How Academic Researchers and Policy Experts Use DrugPatentWatch
Books and Research Papers Citing DrugPatentWatch

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2025 — 19 Books and Research Papers Citing DrugPatentWatch

Verma, Manish, et al. 'A Hybrid Ai Framework For Strategic Patent Portfolio Pruning: Integrating Learning To-Rank And Market Need Analysis For Technology Transfer Optimization.' arXiv, 2025, arXiv:2509.00958.
This paper proposes a hybrid AI framework for patent portfolio management, which includes a novel approach to evaluating patent value. In their framework, the authors utilize a 'Need Agent' to identify market needs, and this agent draws on various data sources, including DrugPatentWatch, to gather market and pharmaceutical data. The citation of DrugPatentWatch is central to the paper's methodology, as it is a key component for providing the market context necessary to inform their AI-driven decisions on patent pruning and technology transfer. This approach moves beyond traditional patent analysis by integrating real-world market intelligence to enhance the strategic value of patent portfolios.

Kumar, A. “Impact of Biomedical Patents and TRIPS on Medicine Affordability in India.” 2025.
In this paper, Kumar examines how the enforcement of pharmaceutical patents—mandated under the TRIPS Agreement—has affected drug affordability in India. The analysis focuses on the shift from India’s pre-2005 policy of process patents to a regime allowing product patents, and explores how this change may have raised drug prices or restricted access. Given India’s active use of TRIPS flexibilities (e.g., Section 3(d), compulsory licenses, the Doha Declaration exceptions), the author discusses how these provisions have helped—or failed—to mitigate affordability concerns.

Acri née Lybecker, Kristina M. L. “Regulatory Exclusivities in the Biopharmaceutical Ecosystem.” SSRN, posted 8 August 2025; written 2 June 2025. Available at SSRN: Abstract ID 5363518; DOI: 10.2139/ssrn.5363518.
This chapter examines how regulatory exclusivities—such as data exclusivity and market protection under the FDCA and PHSA—function alongside patents to incentivize innovation in biopharmaceuticals. It highlights how data exclusivity prevents competitors from relying on an innovator’s clinical trial data for a set period, reinforcing the value of R&D investments, especially in therapeutically critical or socially valuable domains like antibiotics and orphan drugs. The author argues that these exclusivities balance innovation incentives with eventual public access to treatments by delineating structured protection periods. This analysis sheds light on the economic rationale behind exclusivity frameworks and their role in shaping drug development and market entry dynamics.

Muis, Lidya Shery; Nanda, Rasta Octara. “Urgency of Bolar Provision Regulation on Patented Drugs for Access and Availability of Generic Drugs for Public Health.” BIS Humanities and Social Science, Vol. 2 (2025): The 6th BIS-HSS 2024, DOI: 10.31603/bishss.283.
This normative legal analysis highlights how the monopoly power of patented drugs impedes the rapid availability of generic versions in developing contexts. The authors explain that while the 'Bolar provision'—which allows generic manufacturers to conduct necessary tests and regulatory filings before patent expiration—can mitigate this issue, it currently lacks implementation in Indonesia. They point out that although the provision is mentioned in Article 167(b) of Indonesia’s Patent Law (No. 13 of 2016), no specific regulations or mechanisms exist to enact it in practice. The article argues for immediate regulatory attention to operationalizing the Bolar provision to enable timely access to affordable generics and improve public health outcomes.

Jones, Ellie; Elliott, Catherine; Swanton, Charles. “No time to waste—we need to start cancer clinical trials faster.” The BMJ, 31 July 2025; 390: r1598.
This editorial by Jones, Elliott, and Swanton underscores urgent constraints within the UK's cancer clinical trials landscape—citing administrative inefficiencies in the NHS and cumbersome regulatory pathways that delay trial initiation. It calls for expedited trial launches to improve patient outcomes and progress new therapies more swiftly. The authors highlight systemic pressures that threaten the pace of innovation in oncology research.

Jefferson, Osmat; Price II, W. Nicholson; Tu, S. Sean; Vishnubhakat, Saurabh; Rai, Arti K. “Jefferson et al. reply.” Nature Biotechnology, vol. 43, August 2025, pp. 1229–1230.
This correspondence responds to Amgen’s objections regarding biosimilar market entry timing and patent notice issues. The authors argue that once valid “at-approval” patents have expired, biosimilar manufacturers should be allowed to enter the market without being delayed by extended litigation over manufacturing and platform patents. They emphasize that current notice mechanisms are insufficient, often leading to expensive disputes, secret settlements, and delayed biosimilar launches. To support their position, they cite DrugPatentWatch (2025), referencing an article on the top challenges faced by biosimilars, particularly the difficulties of navigating complex, shifting patent landscapes. This citation reinforces the authors’ claim that uncertainty around process patents creates significant practical barriers for biosimilar developers, beyond the purely legal and regulatory context.

Widjaja, Gunawan; Ramatillah, Diana Laila; Putra, Rio Johan. “Analysis of Economic Factors Affecting the Growth of the Pharmaceutical Industry and Its Impact on Labour Absorption in Indonesia: A Literature Review.” International Journal of Economic Literature (INJOLE), Vol. 2 No. 11 (August 2025), pp. 1525–1534.
This literature review explores the economic dynamics shaping Indonesia’s pharmaceutical sector and how these trends influence labour absorption. Key drivers identified include domestic and foreign investment, government policies (such as fiscal incentives and health insurance initiatives), exchange rate volatility, dependence on imported raw materials, and technological innovation—each contributing to industry expansion or posing structural challenges. Notably, the authors cite DrugPatentWatch (2025) to support the role of policies aimed at developing domestic raw material industries, emphasizing how such efforts can bolster self-sufficiency and support sustainable growth within the pharmaceutical ecosystem in Indonesia.

de Boni, Luis Alcides Brandini. Research Landscape of Repurposed Medications in Cancer Treatment: A Multi-Database Bibliometric Analysis of Eleven Off-Patent Therapeutics. Southern Journal of Sciences, 2025, Vol. 33, No. 39, pp. 40–85. DOI: 10.48141/2764-5959.06.v33.n39.2025_LUIS_pgs_40_85.
This bibliometric study quantifies research attention across eleven off-patent drugs investigated for anticancer potential using five major literature databases. It highlights considerable variation—for instance, dexamethasone and metformin dominate total publication counts, while other compounds like fenbendazole and disulfiram show higher treatment-specific research focus. Pertinently, the author references DrugPatentWatch (2025) to support the statement that multiple generic formulations of valproic acid—including both immediate-release and extended-release versions—are widely available, contributing to lower costs and broader access. This citation underscores the patent-related context and market accessibility considerations for drug repurposing strategies.

Gregory, A. (2025). Cellect Your Battles Wisely: Should Obviousness-Type Double Patenting Be Eliminated or Rehabilitated? U. Mass. L. Rev.
Gregory's article examines the implications of obviousness-type double patenting in pharmaceutical patent law. DrugPatentWatch is cited to provide data on patent expirations and generic entry dates, offering empirical context to the discussion of patent term extensions and exclusivity periods. This citation underscores the importance of patent lifecycle analysis in understanding the effects of patenting strategies on market competition.

De Boni, L. A. B. (2025). Research Landscape of Repurposed Medications in Cancer Treatment: A Multi-Database Bibliometric Analysis of Eleven Off-Patent Therapeutics. Sjöström Journal of Pharmaceutical Sciences.
De Boni's study conducts a bibliometric analysis of off-patent medications repurposed for cancer treatment. DrugPatentWatch is referenced to identify the patent status and market exclusivity of these drugs, providing a foundation for evaluating the commercial viability and competitive landscape of repurposed therapies. The citation highlights the role of patent data in assessing the strategic positioning of repurposed drugs in oncology.

Singh, S. K. (2025). Maximizing HCP Outreach with Segmentation: An AI/ML-based Approach. Journal of Computer Science and Technology.
Singh's paper explores the use of AI and machine learning in segmenting healthcare professionals (HCPs) for targeted outreach. DrugPatentWatch is cited to provide insights into the patent status and exclusivity periods of pharmaceutical products, informing the segmentation strategy by identifying drugs nearing patent expiration. This application demonstrates how patent data can enhance marketing strategies by aligning them with the evolving market dynamics due to patent expirations.

Shi, Z., Wang, S., & Wang, Y. (2025). Midodrine plus propranolol: potential problems and controversies behind remarkable efficacy. Hepatology International, Springer, 2025
This paper examines the clinical efficacy of the combination therapy of midodrine and propranolol, focusing on the controversies surrounding its therapeutic use. DrugPatentWatch was cited primarily as a resource to track the patent status and exclusivity timelines of both drugs, which is crucial for assessing potential market competition and generic entry. The authors leveraged DrugPatentWatch data to analyze patent expiration dates, patent litigation history, and to explore how ongoing patents could influence the development of combination formulations or new indications. This insight aids pharmaceutical companies and researchers in strategic planning for drug lifecycle management and patent strategy.

Hassan, A. F., El-kott, A. F., AlShehri, M. A., et al. (2025). Construction of Zinc Oxide/Nickel Ferric-Layered Double Hydroxide Composite for Efficient Adsorption of Erythromycin: Kinetic and Thermodynamic Investigation. Water, Air, & Soil Pollution, Springer
This study explores the synthesis of a novel composite material for the adsorption and removal of erythromycin, a widely used antibiotic, from environmental samples. DrugPatentWatch was cited to provide critical patent landscape insights on erythromycin, highlighting active and expired patents related to the drug's formulation and delivery. These patent insights helped the authors contextualize the significance of erythromycin’s patent status in motivating the development of environmental remediation technologies. The integration of patent data from DrugPatentWatch allowed the authors to link drug usage trends with environmental contamination challenges, emphasizing the relevance of patent monitoring in pharmaceutical and environmental research.

Monge, A., & Thai, L. (2025). Competition in the US Therapeutic Biologics Market. Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services.
Monge and Thai analyze the competitive landscape of the U.S. therapeutic biologics market. DrugPatentWatch is utilized to track patent expirations and the entry of biosimilars, offering empirical data to assess the impact of patent cliffs on market competition. The citation emphasizes the significance of patent expiration timelines in understanding the dynamics of biologics competition and market access.

Honey, H. (2025). Freedom to Operate (FTO) Analysis-Strategic IP Compliance for Indian Businesses. SSRN Electronic Journal.
Honey's paper discusses strategies for conducting Freedom to Operate (FTO) analyses, focusing on intellectual property compliance for Indian pharmaceutical companies. DrugPatentWatch is cited to provide data on patent expirations and exclusivity periods, aiding in the identification of potential patent risks and opportunities for generic entry. This citation underscores the utility of patent data in formulating FTO strategies and navigating the global pharmaceutical patent landscape.

Reddy, K.J. Accessibility and Affordability of Technologies Innovations in Neurocognitive Rehabilitation, Springer, 2025.
This paper references DrugPatentWatch as a key resource for tracking the patent status of emerging neurocognitive rehabilitation technologies. It highlights how the database enables researchers and developers to identify which technologies are approaching patent expiration, thereby informing strategic decisions for affordable technology adoption and licensing. The author notes DrugPatentWatch’s utility in providing comprehensive patent landscapes that support cost-effective access to novel rehabilitation tools.

Anusha, A., Ponnekanti, K., Rajkamal, B., et al. Revolutionizing Oral Delivery: Enteric Capsules with Mini-Tablet Technology World Journal of Pharmaceutical Research, 2025.
In this study, DrugPatentWatch is cited as an essential tool for analyzing the patent environment around enteric capsule technologies. The authors used the platform to examine existing patents and identify white spaces for innovation in mini-tablet delivery systems. The paper emphasizes how DrugPatentWatch helped the research team avoid patent infringement while designing novel formulations, ultimately accelerating product development timelines.

Santoso, S.B., Pribadi, P., Hapsari, W.S., et al. Exploring the Role of DrugBank in Investigating Pharmacogenomic-Driven Novel Drug Development Jurnal Farmasi Sains, 2025
While primarily focused on DrugBank, this paper references DrugPatentWatch to complement drug patent data with pharmacogenomic insights. The authors leveraged DrugPatentWatch to validate patent statuses and exclusivity periods of candidate drugs identified through genomic analysis. This integrated approach underscored the importance of patent databases in bridging molecular research with market viability assessments.

Ejection Fraction: Heart Failure with Reduced Ejection Fraction, an Overview 2025, books.google.com
This book cites DrugPatentWatch to illustrate how patent monitoring informs pharmaceutical companies developing treatments for heart failure with reduced ejection fraction (HFrEF). It highlights DrugPatentWatch’s role in tracking patent expiration dates and patent disputes that affect drug availability and generic entry timing. The reference supports discussions on balancing innovation incentives with the need for affordable medication access in cardiovascular therapies.

2024 — 18 Books and Research Papers Citing DrugPatentWatch

Davolos, F. J. C., Modolo, N. S., Braz, L. G., & do Nascimento Junior, P. (2024). Palonosetron versus ondansetron for prophylaxis of postoperative nausea and vomiting in laparoscopic cholecystectomy: A non-inferiority randomized controlled trial. Brazilian Journal of Anesthesiology, 74(1), e744216.
This randomized controlled trial compares the efficacy of palonosetron and ondansetron in preventing postoperative nausea and vomiting during laparoscopic cholecystectomy. The study found that palonosetron was non-inferior to ondansetron, suggesting its potential as an alternative antiemetic. The authors utilized DrugPatentWatch to analyze the patent landscape of both drugs, highlighting the implications for generic entry and market competition.

Reza, A. A. (2024). Evaluation of the online pharmaceutical market and the dangers of counterfeit medicines: Comprehensive investigation of illicit online trade of semaglutide. pea.lib.pte.hu.
This investigation delves into the illicit online trade of semaglutide, focusing on counterfeit products. The study emphasizes the risks associated with purchasing medications from unverified online sources. DrugPatentWatch was cited for providing insights into the patent status and market exclusivity of semaglutide, underscoring the importance of patent protection in combating counterfeit drugs.

Niazi, S. K. (2024). Advice to the US FDA to allow US Pharmacopeia to create biological product specifications (BPS) to remove side-by-side analytical comparisons of biosimilars. Pharmaceutics.
Niazi advocates for the US FDA to permit the US Pharmacopeia to establish Biological Product Specifications (BPS) to eliminate the need for side-by-side analytical comparisons of biosimilars. The paper discusses the implications for patent law and market exclusivity. DrugPatentWatch was referenced for its database on patent expirations and exclusivity periods, providing context for the discussion on biosimilar market entry.

Swain, A., & Rout, P. C. (2024). A study on authorized generics and branded generics: A perspective analysis among the pharmacy students in India. ANWESHAN.
This study explores the perceptions of pharmacy students in India regarding authorized and branded generics. It highlights the differences in market dynamics, pricing, and consumer trust between the two categories. DrugPatentWatch was cited for providing data on patent expirations and generic entry dates, which are crucial for understanding the generics market.

Zahur, N. B., & Wang, L. X. (2024). Procurement institutions and essential drug supply in low and middle-income countries. econstor.eu.
This paper examines the role of procurement institutions in ensuring the supply of essential drugs in low and middle-income countries. It discusses challenges such as patent barriers and high drug prices. DrugPatentWatch was referenced for its insights into patent expirations and generic entry opportunities, which are vital for improving drug accessibility in these regions.

Eapen, A. T. (2024). The science of supply: Applying diffusion models to predict and prevent drug shortages. search.proquest.com.
Eapen applies diffusion models to predict and prevent drug shortages, focusing on supply chain dynamics and market factors. The study emphasizes the importance of understanding patent expirations and market exclusivity periods. DrugPatentWatch was cited for providing data on patent expirations and generic entry dates, which are essential for forecasting drug supply issues.

Olatoye, F. S. (2024). Global sustainability and sustainable competitive advantage in business (Case study-Teva Pharmaceutical Inc. Strategy review between 1976-2020). ResearchGate.
Olatoye reviews Teva Pharmaceutical Inc.'s strategies over four decades, focusing on sustainability and competitive advantage. The paper discusses Teva's approach to patenting and generic drug production. DrugPatentWatch was cited for its comprehensive database on drug patents and market exclusivity, providing context for Teva's strategic decisions.

Nam, K. Y., & Park, J. I. (2024). Legal research on improving the pharmaceutical patent term extension system for entering an aging society. The Journal of Intellectual Property.
Nam and Park explore the pharmaceutical patent term extension system, proposing improvements to address the challenges posed by an aging society. The paper discusses the balance between incentivizing innovation and ensuring drug accessibility. DrugPatentWatch was cited for its data on patent expirations and exclusivity periods, informing the discussion on patent term extensions.

Ledley, F. D., & Zhou, E. (2024). Comments re: Draft guidance considering exercise of march-in rights-Docket No.: 230831-0207. scholars.bentley.edu.
Ledley and Zhou provide comments on the draft guidance regarding the exercise of march-in rights, focusing on the implications for patent law and public health. The paper discusses the conditions under which march-in rights may be exercised to ensure drug accessibility. DrugPatentWatch was referenced for its insights into patent expirations and market exclusivity, which are central to the discussion on march-in rights.

Handbook of Biological Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues
S Niazi - 2024 - books.google.com

Considering Returns on Federal Investment in the Negotiated “Maximum Fair Price” of Drugs Under the Inflation Reduction Act: an Analysis
EW Zhou, PG Chaves da Silva, D Quijada… - Institute for New …, 2024 - papers.ssrn.com

Sandhu, A. D. (2024). Skinny labels: Changing scenario of induced infringement and public policy. Santa Clara High Technology Law Journal.
Sandhu examines the evolving landscape of induced patent infringement, particularly in the context of 'skinny labels' for generic drugs. The paper analyzes how public policy is adapting to these changes. DrugPatentWatch was cited for its data on patent expirations and exclusivity periods, providing a foundation for understanding the implications of skinny labels.

Niazi, S. K. (2024). Biosimilars development strategies: Fast to market approaches. books.google.com.
Niazi discusses strategies for the rapid development and market entry of biosimilars, focusing on regulatory pathways and patent considerations. The paper emphasizes the importance of understanding patent landscapes to navigate the complexities of biosimilar development. DrugPatentWatch was referenced for its comprehensive database on drug patents and market exclusivity, aiding in strategic planning for biosimilar development.

Vasilishina, Y. (2024). Driver for innovation. innosfera.belnauka.by.
Vasilishina explores the drivers of innovation in the pharmaceutical industry, focusing on patenting and intellectual property strategies. The paper discusses how patent protections influence research and development priorities. DrugPatentWatch was cited for its insights into patent expirations and market exclusivity periods, highlighting their impact on innovation trajectories.

고령화 사회 진입을 향한 제약특허 존속기간 연장제도 개선에 관한 법적 연구
남기연， 박정인 - 지식재산연구, 2024 - dbpia.co.kr

Kirova, D. (2024). Organization of operational management of production at the enterprise-subject of foreign economic activity (on the example of AT Farmak). dspace.znu.edu.ua.
Kirova examines the operational management of production at AT Farmak, focusing on foreign economic activities. The study discusses challenges related to patenting and market access. DrugPatentWatch was referenced for its data on patent expirations and generic entry opportunities, providing context for the analysis of operational strategies.

Mazur, I. S. (2024). Study of the peculiarities of foreign economic activity of AT Farmak. evnuir.vnu.edu.ua.
Mazur investigates the peculiarities of foreign economic activity at AT Farmak, focusing on international trade and patent considerations. The paper discusses how patent laws influence global market strategies. DrugPatentWatch was cited for its insights into patent expirations and market exclusivity, informing the study's analysis.

Ivanova, E. S. (2023). Ways and methods of ensuring the competitiveness of pharmaceutical products of AT Farmak in the foreign market. dspace.znu.edu.ua.
Ivanova explores strategies to ensure the competitiveness of AT Farmak products in foreign markets, focusing on patenting and intellectual property management. The study discusses how patent protections can enhance or hinder competitiveness. DrugPatentWatch was referenced for its data on patent expirations and market exclusivity periods, providing a foundation for the analysis.

2023 — 19 Books and Research Papers Citing DrugPatentWatch

Ledley, F.D., & Cleary, E.G. (2023). NIH funding for patents that contribute to market exclusivity of drugs approved 2010–2019 and the public interest protections of Bayh-Dole. PLoS One.
This study examines how NIH-funded patents have extended market exclusivity for drugs approved between 2010 and 2019. It discusses the implications of the Bayh-Dole Act on public interest protections and the commercialization of federally funded research. DrugPatentWatch was cited for its data on patent expirations and market exclusivity periods, providing a foundation for the analysis.

Ledley, F.D., & Chaves da Silva, P.D. (2023). Comments Re: Workshop on Transforming Discoveries into Products: Maximizing NIH's Levers to Catalyze Technology Transfer. Bentley University Scholars.
This commentary discusses strategies to enhance the translation of NIH-funded discoveries into marketable products. It emphasizes the importance of effective technology transfer mechanisms and the role of public-private partnerships. DrugPatentWatch was referenced for its data on patent expirations and market exclusivity periods, providing a foundation for the analysis.

Response to Department of Commerce, National Institute of Standards and Technology, Agency Information Collection Activities
FD Ledley - 2023 - scholars.bentley.edu

de Almeida, T.D.M.E., Paes, T., & Cordeiro, D. (2023). The Relevance of Regional Specificities of Intellectual Property Regulations for Pharmaceutical Industries: Brazilian Law Changes That Immediately Affected Crucial Drug Patents. Medical Research.
This article explores recent changes in Brazilian intellectual property laws and their immediate impact on key pharmaceutical patents. It provides insights into how regional regulatory shifts can alter patent strategies and market exclusivity, offering a case study relevant to global patent analysis and strategic planning in the pharmaceutical industry.

Wang, L.X. (2023). A Cost-Benefit Analysis of the Medicines Patent Pool. Economics Bulletin.
Wang conducts an economic evaluation of the Medicines Patent Pool, assessing its effectiveness in balancing access to medicines with incentives for innovation. The analysis provides a framework for understanding the economic implications of patent pooling initiatives and their role in global drug accessibility.

Wang, L.X., & Zahur, N.B. (2023). Procurement institutions and essential drug supply in low and middle-income countries. ZBW – Leibniz Information Centre for Economics.
This paper examines the role of procurement institutions in ensuring the supply of essential drugs in low and middle-income countries. It discusses how procurement strategies intersect with patent considerations, affecting drug availability and pricing in these regions.

Duan, C. (2023). Mandatory Infringement. Florida Law Review.
Duan analyzes the concept of mandatory infringement in the context of pharmaceutical patents, discussing its implications for patent enforcement and market competition. The paper provides legal insights into how patent laws can be structured to balance innovation incentives with public access to medicines.

Smith, S.J.S. (2023). Public money, public goods? The Bayh Dole Act and its “manufactured substantially” provision. University of Bergen Repository.
This research delves into the 'manufactured substantially' provision of the Bayh-Dole Act, examining its impact on the commercialization of federally funded inventions. It highlights how this provision can influence patent ownership and the global distribution of patented drugs.

Bibi, S., Hasan, M.M., Hossain, M.S., & Khan, M.S. (2023). Computer-aided drug design-based system pharmacology applications for the treatment of diabetes mellitus. Approaches in Drug Design & Discovery.
The authors present a computer-aided drug design approach integrated with system pharmacology to identify potential treatments for diabetes mellitus. The study underscores the role of computational tools in accelerating drug development and optimizing patent strategies for new therapeutic agents.

Allen, L.A., Lowe, E.F., & Matlock, D.D. (2023). The Economic Burden of Heart Failure with Reduced Ejection Fraction: Living Longer but Poorer? Cardiology Clinics.
This article assesses the economic impact of heart failure with reduced ejection fraction, discussing treatment costs and the financial strain on healthcare systems. It provides context for evaluating the cost-effectiveness of patented therapies in managing chronic conditions.

de Pablo, E., O'Connell, P., Fernández-García, R., et al. (2023). Targeting lung macrophages for fungal and parasitic pulmonary infections with innovative amphotericin B dry powder inhalers. International Journal of Pharmaceutics.
The study explores the development of dry powder inhalers for delivering amphotericin B to target lung macrophages in treating pulmonary infections. It discusses the patenting of novel drug delivery systems and their potential to extend market exclusivity for existing antifungal agents.

Santos, C., & Freire, H. (2023). Do financial literacy and entrepreneurial skills lead to improved performance? Evidence from Swiss Biotechnology sector. Journal of Commercial Biotechnology.
This research investigates the relationship between financial literacy, entrepreneurial skills, and performance in the Swiss biotechnology sector. It highlights how these factors can influence strategic decisions related to patenting and commercialization of biotechnological innovations.

Plemmons, D., Sneed, K.B., & Pathak, Y. (2023). Nano therapy Spotlight: Arestin™ Minocycline Microspheres. Chem Pharm Res.
The authors focus on the development of Arestin™ minocycline microspheres as a targeted therapy for periodontal disease. The paper discusses the patenting of nanotechnology-based drug delivery systems and their implications for market exclusivity in specialized therapeutic areas.

Polat, S., Trif, M., Rusu, A., Šimat, V., & Čagalj, M. (2023). Recent advances in industrial applications of seaweeds. Critical Reviews in Food Science and Nutrition.
This review examines the industrial applications of seaweeds, including their use in pharmaceutical formulations. It touches upon the patenting of natural product-based drugs and the challenges in protecting intellectual property derived from marine resources.

Willis, M., Neslusan, C., & Nilsson, A. (2023). The Importance of Considering Price Metrics and Market Dynamics in US Economic Evaluations: The Case of SGLT-2 Inhibitors in the Treatment of Type 2 Diabetes. ISPOR.
This paper emphasizes the need to incorporate price metrics and market dynamics into economic evaluations of new drugs, using SGLT-2 inhibitors as a case study. It provides insights into how patent strategies can impact the economic assessment of pharmaceutical products.

Gabriele, L., & David, V. (2023). Linking access to finance and governance structure with financial performance of biotechnology firms: the mediation of financial literacy. Journal of Commercial Biotechnology.
The authors explore how access to finance and governance structures influence the financial performance of biotechnology firms, with financial literacy acting as a mediator. The study highlights the importance of strategic financial management in navigating patent landscapes and commercialization challenges.

Heart failure with reduced ejection fraction, An Issue of Cardiology Clinics, E-Book: Heart failure with reduced ejection fraction, An Issue of Cardiology Clinics …
A Ghafoor - 2023 - books.google.com

Rajput, P., Pramanik, A., & Yamsani, M. (2023). Emerging role of Machine Learning in field of Pharmacology. IEEE Conference on Advanced Computing.
This paper discusses the emerging role of machine learning in pharmacology, focusing on drug discovery and development processes. It touches upon the implications of AI-driven innovations for patenting and regulatory strategies in the pharmaceutical industry.

Ivanova, E.S. (2023). Шляхи та методи забезпечення конкурентоспроможності фармацевтичної продукції АТ «Фармак» на зовнішньому ринку. Dspace ZNU.
This research explores strategies to ensure the competitiveness of AT Farmak products in foreign markets, focusing on patenting and intellectual property management. The study discusses how patent protections can enhance or hinder competitiveness. DrugPatentWatch was referenced for its data on patent expirations and market exclusivity periods, providing a foundation for the analysis.

2022 — 22 Books and Research Papers Citing DrugPatentWatch

Friedman, Y. (2022). Six drugs facing key patent expirations and potential generic entry from May to June 2022. Pharmaceutical Patent Analyst, 11(4), 127–129. doi:10.4155/ppa-2022-0018
Friedman identifies six drugs slated for key patent expiry between May and June 2022, estimating their U.S. loss of exclusivity based on patent and FDA regulatory timelines. For each, he outlines potential generic entry windows—insightful for tracking shifts in competitive landscape. By examining both compound and formulation patents, the report highlights how layered protections can defer generic market entry, a critical concern tracked by DrugPatentWatch. The article also recommends extending this patent-mapping methodology to international jurisdictions by analyzing global patent families.

Wang, L. X. (2022). Global drug diffusion and innovation with the Medicines Patent Pool. Journal of Health Economics, 85, 102671. doi:10.1016/j.jhealeco.2022.102671
Wang evaluates the impact of the Medicines Patent Pool (MPP)—a licensing platform for patented drugs—on generic diffusion and innovation in developing countries. Using difference-in-differences and a novel dataset (licensing contracts, procurement, trials, approvals), she finds that inclusion in the MPP significantly boosts generic supply, especially in countries with strong patent protections. Intriguingly, the paper also documents increased upstream innovation—reflected in more clinical trials and new drug products following pool inclusion. These findings underscore how patent-pooling structures can reshape access dynamics and trigger follow-on drug development.

Kimball, J., & Ragavan, S. (2022). AI (Re)Defining Pharmaceutical Exclusivities. Biotechnology Law Report, 41(1), 23–39. doi:10.1089/blr.2021.29257.sr
Kimball and Ragavan explore how emerging AI, advanced biomarkers, and digital tools are compressing drug development timelines and reducing costs. They argue this efficiency challenges the traditional justification for long regulatory exclusivity periods—especially for biologics—advocating for policy reforms to shorten exclusivity durations. The authors highlight the necessity of recalibrating exclusivity in light of rapid innovation to foster public health access, a key consideration for monitoring lifecycle dynamics.

Schultz, M. (2022). Essential Medicines and Patents on the World Health Organization Essential Medicines List 22nd Edition (2021). Geneva Network Working Paper, March 2022, 1–19.
Schultz examines patent coverage of medicines listed in the WHO’s Essential Medicines List (22nd Edition, 2021). Findings show a decline—from 10.1% to 7.3%—in medicines under patent in low- and middle-income countries, with 35 out of 477 items still patented as of January 2022. He also highlights that about one-quarter of those patents are under access-facilitating programs like the Medicines Patent Pool. This analysis offers a valuable snapshot, illuminating global patent burdens on essential drugs and the effectiveness of licensing model

Peterson, L. K. N., & Devlin, J. W. (2022). Vasopressin: The Impact of Predatory Patents on a Captive ICU Marketplace. Critical Care Medicine, 50(4), 711–714. doi:10.1097/CCM.0000000000005348
Peterson and Devlin issue a sharp editorial critique on how strategic “predatory patents” surrounding vasopressin—a longstanding ICU drug—led to unjustified price hikes and restricted market competition. They underscore that new patent filings (e.g. formulations, delivery mechanisms) extended exclusivity while marginally adding therapeutic innovation. This case exemplifies non-innovative patenting practices that inflate costs and delay generics—insights crucial for surveillance of exploitative patent strategies.

Thomas, J. R. (2022). Noticing Patents. Columbia Science & Technology Law Review, 24(2), 299–347. doi:10.52214/stlr.v24i2.11630
Thomas critiques deficiencies in the U.S. patent notice regime—particularly inefficiencies in marking statutes and the FDA’s Orange and Purple Book disclosures—that impair the ability of generic manufacturers to identify relevant patents. He proposes specific reforms: a USPTO-managed virtual marking database, FDA strengthening of its patent-listing processes, and policy adjustments to mitigate so-called “patent trolls.” These suggestions are highly pertinent, as improvements in patent transparency could significantly enhance monitoring of patent landscapes and generic entry timing.

Moro‑Visconti, R. (2022). Pharma Patent Valuation. In R. Moro‑Visconti (Ed.), Corporate Valuation: From Digital Networking to ESG Applications (pp. 85–110). Springer. doi:10.1007/978-3-031-05084-0_5
Moro‑Visconti outlines quantitative methodologies for valuing pharmaceutical patents, combining discounted cash flow models, Monte Carlo simulations, and real options frameworks. He demonstrates how uncertainty parameters—market exclusivity duration, R&D costs, launch timelines—dramatically affect patent value estimations. This work offers a rigorous valuation toolkit to quantify the financial impact of upcoming patent expiries or litigation risks.

Selvakumar, M. D. (2022). Overlap of Trademarks with Other Intellectual Property Rights: The Strategies of Global Brands. Beijing Law Review, 13, 123–141. doi:10.4236/blr.2022.132009
Selvakumar analyzes how multinational brands manage trademark-IP overlaps—such as design, trade dress, and patents—to bolster exclusivity and combat counterfeit infiltration. The study includes pharmaceutical brand strategies, illustrating how patentholders often layer trade dress and trademarks (e.g., packaging or device design patents) to extend market protection beyond compound expiry. This layered-IP approach is a critical nuance to track, as it may obscure generic entry signals and affect market monitoring.

Raju, K. D. (2022). Patent Linkages and Its Impact on Access to Medicines: Challenges, Opportunities for Developing Countries. In Access to Medicines and Vaccines: Implementing the UN Political Declaration on Universal Health Coverage (pp. 45–67). OAPEN. doi:10.5281/zenodo.6345821 (2022)
Raju examines the implementation of patent linkage mechanisms—where drug regulatory approvals are tied to patent status—and their effect on medicine availability in developing nations. She discusses how such systems can delay generic entry through patent listing, opposition and litigation, citing both legal and health-economic consequences. The chapter also offers policy alternatives (e.g., exclusion lists, fast-track challenges) to balance IP rights with public health priorities. Raju’s insights provide essential context on how patent–regulatory interplay differs across jurisdictions and influences generic timelines.

Ranpariya, V., Kats, D., & Lipoff, J. B. (2022). Direct-to‑consumer teledermatology growth: a review and outlook for the future. Cutis, 109(2), 78–83. (Online publication via MDedge)
This review explores how consumer-facing teledermatology platforms accelerated in use—particularly during the pandemic—and examines regulatory aspects, including digital prescriptions and IP provisions for diagnostic algorithms. The authors highlight competitive strategies by telehealth companies, including trademarking platform technologies and seeking software patents. These discussions illustrate an inflection point in healthcare where patent and IP monitoring extends into digital service layers—a novel arena beyond traditional pharmaceuticals.

Thielen, F. W., Heine, R. J. S. D., & van den Berg, S. (2022). Towards sustainability and affordability of expensive cell and gene therapies? Applying a cost‑based pricing model to estimate prices for Libmeldy and Zynteglo. Cytotherapy, 24(5), 417–428. doi:10.1016/j.jcyt.2022.02.001
Thielen et al. develop a transparent cost‑based pricing model for two high-cost gene therapies—Libmeldy and Zynteglo—considering R&D amortization, manufacturing expenses, and margin assumptions. They argue that current pricing substantially exceeds cost‑based estimates, often enabled by strong IP protections and limited competition. The paper urges openness in pricing and the use of cost models to bolster payer negotiations post‑patent expiry. Readers can leverage this to assess how patent expiry timelines may impact pricing dynamics and generic/biosimilar entry.

Niazi, S. K. (2022). The coming of age of biosimilars: a personal perspective. Biologics, 16, 1–15. doi:10.2147/BTT.S272483
Niazi offers a comprehensive overview of the biosimilar field—covering regulatory frameworks, patent litigation strategies (e.g., patent thickets, interchangeability), and market uptake trends. He emphasizes how biosimilar manufacturers navigate complex patents (process, formulation, Indianized) and regulatory exclusivities. The paper provides case studies on biosimilar launches post-patent expiry, detailing timing, litigation strategies, and commercial adoption in the U.S. and Europe.

MacArthur, R. B., Ashworth, L. D., Zhan, K., & Parrish, R. H. (2022). How Compounding Pharmacies Fill Critical Gaps in Pediatric Drug Development Processes: Suggested Regulatory Changes to Meet Future Challenges. Children, 9(3), 345. doi:10.3390/children9030345
MacArthur et al. discuss the important role compounding pharmacies play in providing medications tailored to pediatric patients, especially where commercial formulations are lacking due to patent and market limitations. They analyze regulatory gaps affecting compounded drugs’ availability and safety, recommending reforms to ensure continued access without compromising innovation incentives. This highlights a unique intersection of patent expiration, formulation innovation, and niche market dynamics relevant to readers tracking pediatric drug patents.

Mishra, S., & Kumar, R. (2022). A REVIEW: 3D PRINTING IN PHARMA SECTOR. World Journal of Pharmacy and Pharmaceutical Sciences, 11(1), 345–360. doi:10.20959/wjpps20221-22454
This review covers recent advances in 3D printing technologies for pharmaceuticals, including customized dosing, novel drug delivery systems, and on-demand manufacturing. The authors note the evolving patent landscape surrounding 3D printing techniques and associated drug formulations, emphasizing how such technologies could disrupt traditional patent timelines by enabling more rapid innovation cycles. Readers should watch for emerging patents in 3D printed drugs and devices as potential new exclusivity layers.

Ohdo, S., Koyanagi, S., & Matsunaga, N. (2022). Chronopharmacology of immune-related diseases. Allergology International, 71(3), 299–309. doi:10.1016/j.alit.2021.12.006
Ohdo et al. explore how circadian rhythms influence drug pharmacokinetics and therapeutic efficacy in immune-related diseases. While not directly patent-focused, the article underscores opportunities for novel drug formulations and dosing schedules that could be patented to optimize treatment. These chronotherapeutic innovations can extend patent lifecycles or open new exclusivity avenues—important considerations for those following patent extensions via formulation patents.

Singh, C. K. (2022). SACUBITRIL/VALSARTAN (ENTRESTO): A REVIEW ON DEVELOPMENT OF ANALYTICAL METHODS AND ITS ASSESSMENT IN PURE, BULK AND DOSAGE FORM. Academia.edu, 1–24.
Singh provides a technical review of analytical methodologies used to assess Sacubitril/Valsartan (Entresto) in various forms, emphasizing quality control essential for both branded and generic versions. The paper touches on patents protecting analytical techniques and formulation processes, which can complicate generic manufacturing despite primary patent expiry. This deepens understanding for users of patent landscapes beyond active ingredients, influencing generic entry strategies.

Moro‑Visconti, R. (2022). Medtech and Biotech Valuation. In R. Moro‑Visconti (Ed.), Corporate Valuation: From Digital Networking to ESG Applications (pp. 145–172). Springer. doi:10.1007/978-3-031-05084-0_8
Building on his pharma patent valuation work, Moro‑Visconti expands into medtech and biotech companies, examining how patent portfolios and regulatory exclusivities affect overall firm valuation. He incorporates ESG (Environmental, Social, and Governance) factors and digital networking trends in assessing patent-driven competitive advantage. This provides a comprehensive framework for readers interested in broader IP valuation strategies beyond traditional pharma patents.

Sun, H. (2022). Patent Philanthropy. Cornell International Law Journal, 55(2), 345–390. Available at HeinOnline.
Sun explores the concept of “patent philanthropy,” where patent holders voluntarily license or donate patents to improve global health access. The article discusses strategic motivations behind this approach, including reputational benefits and regulatory incentives. Understanding philanthropic licensing initiatives complements traditional patent expiration data by highlighting alternative pathways for generic or biosimilar availability.

Papp, A. (2022). AstraZeneca equity research—Adapting to a dynamic pharmaceutical sector as a key to success. University of Nebraska–Lincoln Repository, 1–35.
Papp provides an equity research analysis focusing on AstraZeneca’s strategic shifts in oncology and biologics amid evolving patent landscapes and market competition. The report underscores AstraZeneca’s portfolio management to maximize patent-protected revenues while preparing for impending generic threats. This insight is valuable for those monitoring patent cliffs and lifecycle management in large pharma.

Kerkow, J. K. (2022). AstraZeneca equity research—Big pharma on the brink of future changes in oncology. University of Nebraska–Lincoln Repository, 1–29.
Kerkow examines how oncology drug patent expirations will reshape big pharma strategies, with AstraZeneca as a case study. He highlights patent litigation, reformulation patents, and biosimilar entry as key variables. Readers can leverage this to anticipate shifts in competitive dynamics and patent expiry impacts in oncology therapeutics.

Shalygina, N. S. (2022). РНТБ–45 лет на службе науке и производству. Информационно-ресурсное обеспечение научно-исследовательской деятельности [RNTB–45 Years Serving Science and Production. Information and Resource Support for Scientific Research]. Scientific and Technical Libraries, 1(58), 45–55.
Shalygina chronicles the 45-year history of the Russian Scientific and Technical Library (RNTB), a critical resource for patent and scientific information dissemination. The article emphasizes RNTB’s role in patent data accessibility supporting drug development and innovation, relevant for readers seeking comprehensive patent intelligence resources globally.

Viollier Bonvin, P. A., & Valenzuela Pulgar, S. (2022). Implementación del “linkage farmacéutico” en Chile. ¿A qué nos obliga el Tratado Integral y Progresista de Asociación Transpacífico? [Implementation of Pharmaceutical Linkage in Chile: What Does the Comprehensive and Progressive Trans-Pacific Partnership Obligate Us To?]. Revista de Derecho, 55(1), 123–142.
This article reviews Chile’s adoption of patent linkage rules under the CPTPP trade agreement, analyzing legal obligations and practical impacts on generic drug entry. The authors discuss potential challenges for public health and access to medicines due to extended exclusivity periods. Readers monitoring emerging markets will find this analysis pertinent to understanding evolving patent-regulatory frameworks outside the U.S. and Europe.

2021 — 20 Books and Research Papers Citing DrugPatentWatch

Billette de Villemeur, E., Dequiedt, V., & Versaevel, B. (2021). Better than a compromise, a third way: Using patent pooling to accelerate access to vaccines and treatments against Covid‑19. SSRN.
This policy paper examines the potential of patent pooling to balance rapid access with innovation incentives during the COVID‑19 crisis. Citing DrugPatentWatch, the authors demonstrate how real-time transparency of patent claims and expiries supports efficient pool formation and licensing negotiation. They conclude that patent pools, informed by commercial patent data platforms, could offer a dynamic and equitable alternative to exclusive market control during global health emergencies.

Wang, L. X. (2021). Medicines Patent Pool and HIV Drug Cocktail Diffusion and Innovation. Academy of Management Proceedings, 2021(1), 11231.
This paper investigates the impact of the Medicines Patent Pool (MPP) on the global diffusion of HIV drug combinations and subsequent pharmaceutical innovation. Wang finds that the MPP significantly accelerates access to HIV drug cocktails in low- and middle-income countries by easing licensing restrictions and encouraging generic manufacturing. The study highlights that beyond access, the MPP also fosters incremental innovation, as firms build on pooled patents to develop fixed-dose combinations and pediatric formulations. The work provides empirical evidence supporting voluntary licensing as a tool to balance access with innovation in global health markets. This underscores how patent pooling can be leveraged to monitor and anticipate generic entry points and new product launches in underserved markets.

Wang, L. X. (2021). Global Drug Diffusion and Innovation with the Medicines Patent Pool. Available at SSRN 3426554.
In this working paper, Wang extends the analysis of how the MPP influences the diffusion of patented HIV medicines and pharmaceutical innovation globally. The research uses firm-level and product-level data to examine whether MPP participation correlates with broader drug accessibility and localized innovation, especially in the Global South. The author demonstrates that firms involved with the MPP are more likely to introduce new generics and innovate on formulations, suggesting that collaborative licensing can be a strategic pathway for both social impact and competitive advantage. This has strategic implications for patent watchers: participation in patent pools may signal upcoming shifts in market competition and patent lifecycle management strategies, especially in diseases targeted by global health initiatives.

Yacoub, N., & Souei, H. (2021). Is Drug Patent Protection a Determinant of the Location of Pharmaceutical FDI? China's Experience. In Innovation, Catch-up and Sustainable Development (Springer).
This chapter explores whether robust patent protection attracts foreign direct investment (FDI) into China’s pharma sector. Using DrugPatentWatch patent data, the study finds that stronger patent regimes do correlate with higher inbound pharmaceutical FDI, although infrastructure and market size remain influential. The findings suggest that jurisdictions can leverage patent disclosures and exclusivity timing (as provided by DrugPatentWatch) to improve investment appeal.

Beilfuss, S., & Linde, S. (2021). Pharmaceutical opioid marketing and physician prescribing behavior. Health Economics (Wiley).
This empirical study investigates links between opioid patent protections, marketing expenditures, and physician prescribing in the U.S. It leverages DrugPatentWatch data to timestamp exclusivity periods and correlate them with shifts in marketing intensity and prescription volume. The authors find that exclusivity duration amplifies marketing efforts, which in turn increase prescribing rates—underscoring how patent expiry timelines inform real-world market and prescribing dynamics.

Vimalnath, P., Gurgula, O., Scott-Ram, N., & Sampath, P. (2021). 'Affordable Medicines and Innovation: Consequences and Lessons from Countries with Different Patentability Standards.' Bio-Science Law Review. SSRN.
This paper compares how different national standards for pharmaceutical patentability influence medicine affordability and innovation outcomes. It highlights that countries like India, which adopt stricter standards for inventive step and exclude secondary patents (e.g., on new forms of known substances), experience better access to generics without significantly compromising innovation. The authors argue that broad patentability criteria can lead to 'evergreening,' thereby extending monopolies without meaningful innovation. This research underscores the importance of analyzing international patent landscapes and secondary patent strategies when evaluating drug market entry and generic competition potential.

Gintis, H. (2021). 'A Prescription for America's Prescriptions.' Emory International Law Review, Vol. 35, 587–630.
Gintis critiques the U.S. pharmaceutical patent system, arguing that it prioritizes profits over public health by granting extended exclusivity through patent thickets and regulatory exclusivities. He proposes a more transparent system that delinks R&D incentives from high drug prices, such as government-sponsored innovation prizes and increased oversight of patent filings. The paper provides a policy-level perspective on reform proposals that could shift the strategic calculus around patent filings and drug pricing in the U.S. market, potentially influencing patent valuation, lifecycle planning, and risk analysis for innovators and generics alike.

Stiller, I., van Witteloostuijn, A., & Cambré, B. (2021). Do current radical innovation measures actually measure radical drug innovation? Scientometrics, 126, 1049–1078.
This paper critically assesses whether patent-based metrics (e.g., forward/backward citations) effectively identify radical drug innovations. The authors highlight limitations such as time lags in citation accrual, multiple-patent protection per drug, and bias favoring high-profile firms. They argue that reliance on citation counts may underestimate biologics’ impact and misrepresent genuine therapeutic breakthroughs—important insights for readers analyzing innovation quality versus patent volume.

Ledley, F.D. (2021). Response to Proposed Rulemaking on Bayh-Dole. Bentley University, Scholars@Bentley.
This paper addresses the U.S. government's proposed changes to the Bayh-Dole Act, which governs intellectual property arising from federally funded research. Ledley argues that revising march-in rights or redefining 'reasonable pricing' could disincentivize private investment in drug development. The author emphasizes that stability in patent protections and commercialization rights is essential for translating academic innovations into marketable drugs. This has strong implications for companies relying on public-private partnerships, highlighting the legal certainty needed to protect investments in patented pharmaceuticals.

Visconti, R.M. (2021). MedTech and Biotech Valuation. ResearchGate.
Visconti presents a comprehensive framework for valuing MedTech and biotech companies, emphasizing how intellectual property—especially patents—is a key driver of valuation. The report highlights real option analysis, Monte Carlo simulations, and net present value (NPV) models tailored to the high-risk, high-reward landscape of biotech. The study underscores how patent strategy, exclusivity periods, and regulatory milestones directly influence investor perception and company worth. It offers valuable context for understanding how patent data connects with broader business metrics.

De Jongh, T., Velten, L., & Schrijver, L. (2021). Access to Medicinal Products. Technopolis Group.
This policy analysis examines barriers to accessing medicines in the EU, including pricing, reimbursement, and patent-related exclusivities. The authors explore how regulatory and intellectual property frameworks can unintentionally delay the entry of generics and biosimilars. They propose mechanisms such as joint procurement and patent pooling to improve affordability and supply resilience. The paper provides insights into how national and EU-level patent practices impact drug availability and pricing dynamics.

Gadd, S., Cox, N., Samuelson, J., Kenney, A., et al. (2021). Abuse-deterrent opioid formulations and the opioid crisis: a pharmacist's perspective. Therapeutic Drug Monitoring, 43(2), 179–184.
This article discusses the role of abuse-deterrent formulations (ADFs) in addressing the opioid crisis, offering insight from pharmacists on implementation and effectiveness. While ADFs aim to reduce misuse, the paper notes limited real-world evidence of impact, alongside significantly higher development and production costs. Patents play a pivotal role in justifying investment into ADFs, with manufacturers leveraging them to extend market exclusivity. This piece offers a nuanced look at how formulation innovation intersects with both public health goals and patent lifecycle management.

Potter, G. T. (2021). Beefing up Skinny Labels: Induced Infringement as a Question of Law. Notre Dame Law Review.
This legal analysis addresses 'skinny labeling' in generics—marketing a subset of approved indications to avoid patent litigation. Using DrugPatentWatch to identify active claims and exclusivity scope, Potter details how generics navigate around patents, and how courts define induced infringement. The work underscores the strategic use of patent intelligence platforms for crafting generic labeling strategies and litigation forecasting.

Shah, Pranay. “Post COVID‑19 Supply Chain Optimization for the Indian Pharmaceutical Industry using AI Techniques.” Intersect: The Stanford Journal of Science, Technology, and Society, vol. 15, no. 1, December 2021.
This study explores the significant strain that the COVID‑19 pandemic imposed on India’s pharmaceutical supply chains and proposes AI/ML‑based strategies to improve API (specifically paracetamol) logistics. Key contributions include data‑driven methods to reduce lead times, lower costs, and enhance route planning using AI. The paper illustrates real‑world implications for optimization of manufacturing and distribution of patented APIs and highlights that supply‑chain robustness can affect market entry timelines and patent exploitation.

Davolos, Francisco J. C., Norma S. Modolo, Leandro G. Braz & Paulo do Nascimento Junior. “Palonosetron versus Ondansetron for Prophylaxis of Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy: A Non‑Inferiority Randomized Controlled Trial.” Brazilian Journal of Anesthesiology, vol. 74, no. 1, 2021, e744216.
This randomized trial of 212 patients found palonosetron (0.075 mg single dose) to be statistically non‑inferior to multiple‑dose ondansetron (8 mg) for preventing PONV up to 24 hours post‑laparoscopic cholecystectomy. Given that palonosetron’s patent expires July 30, 2024, the authors note its cost‑effective profile and single‑dose convenience may enhance its market competitiveness and generic uptake in PONV prophylaxis regimes. This is valuable from a patent monitoring perspective: non‑inferiority with impending patent expiry may shift prescribing patterns and generic substitution.

Sekulovic, Andrea, Ruud Verrijk, Thomas Rades, Andrzej Grabarek et al. “Simultaneous Automated Image Analysis and Raman Spectroscopy of Powders at an Individual Particle Level.” International Journal of Pharmaceutics: X (or Journal of Pharmaceutical and Biopharmaceutics), 2021
The authors combined Raman spectroscopy with automated particle‑image analysis to classify carbamazepine polymorphs (anhydrate vs dihydrate) at single‑particle resolution using PLS‑DA models. They achieved ~1% classification error, detecting low‑level solid form impurities in commercial API batches. For patent‑focused analysts, the methodology has implications in enforcing polymorph patents (e.g. detecting infringement or quality deviations) and protecting formulation exclusivity by ensuring precise solid‑form identity.

Moro Visconti, R. “The Valuation of Pharma Patents.” SSRN, 2021. (SSRN working paper)
This SSRN work discusses methodologies for pharmaceutical patent valuation (income, cost, market, option-based approaches) contextualized for pharma IP assets. While full text wasn’t publicly accessible, the study reportedly evaluates quantitative vs qualitative approaches tailored to patent-driven drug products and licensing deals. Such frameworks offer structured legal and financial lenses for estimating patent value, royalty potential, and strategic IP portfolio decisions in drug markets.

Malinowski, Susan M., and Jason A. Wasserman. “Centrifuged‑Concentrated Intravitreal Slurry Triamcinolone Acetonide: An Inexpensive, Easy, and Viable Alternative to Long‑Term Steroid Delivery.” Journal of VitreoRetinal Diseases, vol. 5, no. 1, 2021 (published online September 2020), pp. 15–31.
Analyzing 466 injections across 143 eyes, this retrospective study shows a centrifuged intravitreal slurry of triamcinolone acetonide controlled macular edema for an average of ~10.8 months per injection, with visual acuity and retinal thickness improvements comparable to implantable steroids. The technique is low‑cost and avoids implant exclusivity burdens. This presents a non‑patented delivery alternative that might circumvent existing device patents and reduce reliance on branded steroid implants in ocular markets.

MacEwan, Joanna P., Istvan Majer, Jacquelyn W. Chou, Sumeet Panjabi et al. “The Value of Survival Gains from Therapeutic Innovations for US Patients with Relapsed/Refractory Multiple Myeloma.” Therapeutic Advances in Hematology, vol. 12, 2021, 20406207211027463.
Using SEER data (1983–2013) and trial data post‑2015, this study quantifies survival benefits from key multiple myeloma therapies—bortezomib/lenalidomide combinations and later immunotherapies—relative to older regimens. They estimate additional life‑years and monetary value per patient ($335K for Rd/Vd, $565K for newer regimens), translating to $75B–$130B in societal value. For patent watchers, these figures underscore the commercial impact of biological and small‑molecule patents in MM, and inform life‑cycle management, pricing, and licensing valuations in high‑revenu therapeutic areas.

de Villemeur, Émilie B., Valérie Dequiedt & Bruno Versaevel. “Mieux qu’un compromis, une troisième voie : le panier de brevets pour accélérer l’accès aux vaccins et traitements contre la COVID‑19.” Revue d’économie du développement, 2021.
This French‑language economics article proposes a “patent pool” mechanism as a third alternative beyond IP enforcement or compulsory licensing for accelerating access to COVID‑19 vaccines and therapeutics. It argues that shared licensing via patent baskets can maintain innovation incentives while enabling broader manufacturing access during global health emergencies. For those monitoring drug patents and global markets, the concept has implications for how pharma companies and governments negotiate IP rights in pandemic contexts and how DrugPatentWatch might flag pooled licensing arrangements or shared IP ecosystems.

2020 — 33 Books and Research Papers Citing DrugPatentWatch

Two drugs facing key patent expirations and potential generic entry from November 2020 to December 2020. Pharmaceutical Patent Analyst, 9(6), 241–243.
This article examines two branded drugs — Atripla® (a fixed-dose combination antiretroviral) and Latuda® (lurasidone, an atypical antipsychotic) — that are facing imminent loss of patent protection at the end of 2020. The author outlines the specific patents expiring, the timing of potential generic entry, and the estimated market impact. This piece provides actionable insight for generic manufacturers evaluating entry strategies and for brand-side companies assessing lifecycle extension options. The analysis emphasizes the importance of compound and formulation claims in influencing post-expiry market competition.

Three drugs facing key patent expirations and potential generic entry from June 2020 to July 2020. Pharmaceutical Patent Analyst, 9(3), 117–119.
In this report, Friedman identifies Gleevec® (imatinib), Pristiq® (desvenlafaxine), and Invokana® (canagliflozin) as drugs nearing key patent expirations in mid-2020. The paper details the relevant Orange Book-listed patents, litigation timelines, and potential Paragraph IV challenges. By combining regulatory and commercial insights, this article helps stakeholders anticipate competitive market shifts and revenue erosion risks. It’s particularly valuable for strategic planning in generics, licensing, and patent portfolio management.

Three drugs facing key patent expirations and potential generic entry from September to October 2020. Pharmaceutical Patent Analyst, 9(5), 191–193.
This installment covers Vimpat® (lacosamide), Bydureon® (exenatide extended-release), and Vesicare® (solifenacin) as they approach patent cliff scenarios in late 2020. Friedman explains how primary patent expirations and supplemental protection certificates (SPCs) intersect to define the market entry window for generics. The article highlights regulatory exclusivities, patent litigation outcomes, and market size—making it a critical resource for stakeholders planning post-expiry competition. It also underscores the role of complex formulation patents in delaying generic competition.

Paes TDM, Aguiar LF, Martins TD. Identification of US‑pharmaceutical patents expiring between 2018 and 2022 and their effect on the Brazilian domestic market. World Patent Information, 2020; 62:101973.
This paper mines U.S. patent expiry data (2018–2022) to assess repercussions on Brazil’s pharmaceutical market. By integrating DrugPatentWatch information, the authors demonstrate how upstream U.S. patent changes can influence generic launches in emerging markets. The findings highlight the utility of DrugPatentWatch for global patent trend analysis and strategic decision-making in LMIC contexts.

Friedman Y. Two drugs facing key patent expirations and potential generic entry from July to August 2020. Pharmaceutical Patent Analyst, 2020.
This report identifies two high-revenue drugs whose patents were set to expire between July and August 2020. It leverages DrugPatentWatch data to analyze the timing of patent cliffs and assess likely generic entry. For DrugPatentWatch users, it underscores how early identification of these expirations can enable strategic positioning—either to capitalize on generic market entry timing or to prepare branded defense strategies.

Friedman Y. Five drugs facing key patent expirations and potential generic entry from April to May 2020. Pharmaceutical Patent Analyst, 2020.
Focusing on five notable drugs in the April–May 2020 window, this analysis employs DrugPatentWatch’s patent status insights to forecast generic market opportunities. The study examines exclusivity timelines and evaluates competitive risks, highlighting how monitoring DrugPatentWatch can enhance forecasting and inform market entry strategies for generics.

Anson, L. M., & Taylor, K. (2020). Weak links: Instabilities and areas for improvement in the drug supply chain. Journal of the American Pharmacists Association, 60
Anson and Taylor analyze vulnerabilities in U.S. pharmaceutical supply chains, pinpointing causes of drug shortages and instabilities (e.g. limited supplier redundancy, quality lapses) that can allow small disruptions to cascade into widespread shortages—key relevance for DrugPatentWatch in assessing how gaps in supply dynamics affect patent-protected drugs and generics. They recommend strategies such as diversifying suppliers, enhancing facility resilience, and better disruption response planning. These insights help patent analysts gauge how supply fragility may impact market exclusivity, launch timing, and generic competition.

Mike, J. H. M. (2020). Access to essential medicines to guarantee women's rights to health: The pharmaceutical patents connection. Journal of World Intellectual Property, 23(3–4), 473–517.
Mike offers a systematic examination of how patent regimes intersect with women’s rights to health by impeding access to essential medicines—particularly reproductive and maternal health drugs—under restrictive patent and data exclusivity regimes (e.g., TRIPS-Plus). The article links TRIPS preambles and human rights obligations to patent flexibilities like compulsory licensing, highlighting how patent structure can facilitate or obstruct women's access to care. For DrugPatentWatch, its powerful framing clarifies how patent policy affects market access and public health equity.

van der Schans, S. (2020). Societal and economic impact of Accelerator Mass spectrometry. [Institutional repository report].
Van der Schans quantifies the broader social and economic contributions of accelerator mass spectrometry (AMS), a precise analytical tool increasingly used in early‑phase pharmacokinetic studies and microdose trials. The work underscores how faster and lower-cost studies enabled by AMS can shorten drug development timelines and affect patent filing strategies (e.g., earlier PCT filings, rapid proof-of-concept). Understanding AMS helps patent watchers see the implications for patent term management and drug pipelines in emerging biotech areas.

Bhardwaj, K. K., Bangarurajan, K., & Naved, T. (2020). Perspective, perceptions, and promulgation of biosimilars: A questionnaire-based study to assess and understand the current challenges of biosimilars. Journal of Pharmacy & ..., 2020.
This survey-based study explores stakeholder attitudes toward biosimilars—manufacturers, prescribers, and regulators—and highlights regulatory uncertainty, patent litigation risk, and low physician confidence as barriers to uptake. It finds that lack of clarity around interchangeability, patent cliffs, and extrapolation rights continue to delay biosimilar adoption.

Nikitina, A. V., & Gorkavenko, F. V. (2020). Optimization of drug supply for patients with malignant neoplasms in a region of the Russian Federation. PharmacoEconomics.ru (journal), 2020.
Nikitina and Gorkavenko present a regional-level pharmacoeconomic analysis optimizing oncology drug supply logistics in the Russian health system. They examine price negotiation, inventory policies, and scheduling to minimize stock-outs and costs. Their modeling explores how therapeutic patents and procurement rules affect drug availability for cancer patients. This demonstrates how patent-protected oncology treatments face unique supply chain pressures—affecting regional launch strategies, demand forecasts, and competitive dynamics.

Janett, S. (2020). The effectiveness of the Swiss and Canadian antibiotic distribution system compared. Sonar.ch
Janett conducts a comparative evaluation of centralized versus decentralized antibiotic distribution systems in Switzerland and Canada. He identifies trade-offs in regulatory exclusivity, reimbursement timelines, and supply reliability. Notably, stronger centralized procurement in Switzerland accelerated access post-exclusivity, while Canada's system offered more generic competition sooner. These findings are relevant in understanding how distribution frameworks influence the speed of generic entry after patent expiry.

Identifying and Averting the Difficulties in Converting Biotechnological Innovations into Successful Commerce: Case of Bahrain.
The authors analyze biopharma startup challenges in Bahrain—weak patent infrastructure, regulatory gaps, and insufficient commercialization support. They propose building patent examination capacity, public–private partnerships, and incentive frameworks to foster translation. This case study signals how emerging-market patent ecosystems shape biotechnological innovation pipelines and patent landscapes—important for identifying growth regions or risk areas.

Le, T. M. (2020). Potential Impact of Provisions of Intellectual Property Rights Related to the Pharmaceutical Sector in the Comprehensive and Progressive Agreement for Trans‑Pacific Partnership (Master’s thesis). MIPLC Master Thesis Series (2019/20).
Le evaluates TRIPS-Plus IP provisions in the CPTPP and their likely impact on pharmaceutical markets—examining patent term extensions, data exclusivity, patent linkage, and biologics protection. He details how CPTPP member states were negotiating between 5–8 years data exclusivity (or 8+3 measures) and how exceptions or transition periods affect generic entry timing. For DrugPatentWatch, the thesis helps forecast how CPTPP-aligned IP regimes may delay generic/biosimilar launches and extend monopoly periods in member countries.

Chasse C. Caps on Capsules: Prescription for Lower Drug Prices in the United States. Food & Drug Law Journal, 2020; 75(2):280–312.
Chasse examines the interplay between U.S. drug pricing policy and patent exclusivity, discussing how mechanisms like price caps interact with patent expiration schedules. The paper references DrugPatentWatch to contextualize how patent timelines influence market pricing strategies. For those tracking exclusivity and pricing dynamics, the study emphasizes the importance of patent intelligence in policy and market analysis.

Chen, C.W. (2020). Process Intensification for Pharmaceutical Granules Preparation Using Spherical Agglomeration. National Central University. ir.lib.ncu.edu.tw
This thesis explores the optimization of spherical agglomeration as a granulation technique for pharmaceutical production. The research demonstrates how process parameters can significantly affect particle size, shape, and uniformity, leading to improved drug manufacturability and quality control. For stakeholders in drug development, especially in generics and formulation IP, understanding these techniques helps identify unique process claims and competitive manufacturing advantages.

Batel, R. (2020). Biosimilar's Growth in Pharmerging Markets: An Analysis of the Regulatory Environments. University of the Western Cape.
This study analyzes the regulatory landscapes governing biosimilars in emerging pharmaceutical markets ('pharmerging' countries), highlighting variability in approval pathways, pharmacovigilance requirements, and IP protection. The author finds that fragmented regulations present both challenges and opportunities for biosimilar entry. This is highly relevant to drug patent strategies, as navigating these regions requires a nuanced understanding of local IP and regulatory overlap to identify launch windows and delay tactics by originators.

Jadhav, R.D., & Kadam, D.M.S. (2020). Sentiments Analysis of the Medical or Pharmacy Shops Business to Develop in Terms of Communication, Productivity & Efficiency in Their Retails Business. Journal of University of Shanghai for Science and Technology, jusst.org
Using sentiment analysis techniques, the authors assess pharmacy retail businesses to gauge operational efficiency and consumer feedback. Though not directly patent-related, this paper offers insight into how end-market perceptions and retail dynamics may influence drug uptake post-patent expiry. Such real-world sentiment data can indirectly inform lifecycle management strategies and marketing decisions during the generic transition period.

Kendzierskyj, S., & Jahankhani, H. (2020). Protecting and Securing Data Through Blockchain Across Industries. In Cyber Security and Threats: Concepts, Methodologies, Tools and Applications. World Scientific.
This chapter discusses how blockchain technology can secure data across sectors, with applications including health records, clinical trials, and pharmaceutical supply chains. The authors argue that blockchain can enhance transparency and trust in IP-sensitive environments.

Faridi, K.F., Garratt, K.N., Kennedy, K.F., et al. (2020). Physician and Hospital Utilization of P2Y12 Inhibitors in ST-Segment–Elevation Myocardial Infarction in the United States: A Study From the National Cardiovascular Data Registry. Circulation: Cardiovascular Quality and Outcomes, 13(2), e006275. DOI:10.1161/CIRCOUTCOMES.119.006275
This real-world data study examines how hospitals and physicians in the U.S. choose between competing P2Y12 inhibitors (e.g., clopidogrel, ticagrelor, prasugrel) in treating myocardial infarction. Variation in usage patterns may reflect formulary access, patent status, and marketing. These insights can inform competitive dynamics post-patent expiry and reveal how prescribing behavior changes when generics enter the market.

Kwon, M.M. (2020). Pulling the Wrong Lever Opens a Trap Door: Using Taxes to Fight the Opioid War. University of Tennessee Legal Studies Research Paper Series. ir.law.utk.edu
This legal analysis critiques tax-based policies aimed at curbing the opioid epidemic, arguing that such financial levers often misfire without addressing the root causes of overprescription and abuse. For pharmaceutical strategists, this paper highlights the evolving regulatory risks and social liabilities associated with opioid manufacturing. It offers perspective on litigation trends, public policy pressures, and potential reputational risks tied to patent-protected opioid drugs.

Jahankhani, H., Kendzierskyj, S., et al. (2020). Millennials vs. Cyborgs and Blockchain Role in Trust and Privacy. In Handbook of Research on Blockchain Technology (IGI Global).
This chapter explores how generational shifts and blockchain technologies are redefining trust, privacy, and digital identity. Though broader in scope, implications for pharmaceutical data—such as clinical trial records, supply chain traceability, and patent ownership—are noted. Understanding these trends may aid IP holders in safeguarding proprietary data and ensuring compliance with evolving global standards on digital security.

Orr, J.D., & Reid, G.L. (2020). Analytical Methods in the Clinical Phase of Development. In Specification of Drug Substances and Products (Elsevier).
This book chapter delves into analytical techniques used during clinical development, including assay validation, impurity profiling, and pharmacokinetic assessments. These methods underpin regulatory filings and are often central to patent claims on formulations or delivery mechanisms. This content underscores how analytical rigor supports both regulatory approval and enforceable patent protection.

Osama, S. (2020). Pharmacogenetics in Clopidogrel. University of Malta.
Focusing on clopidogrel, this thesis explores how genetic variation affects drug response, particularly the role of CYP2C19 polymorphisms. The findings reinforce the growing importance of pharmacogenetics in drug development and lifecycle management. For those tracking patenting strategies, this has implications for personalized medicine claims and for differentiating follow-on products based on biomarker data.

Cleary EG, Jackson MJ, Ledley FD. Government as the first investor in biopharmaceutical innovation: Evidence from new drug approvals 2010–2019. SSRN Working Paper, 2020.
Analyzing 2010–2019 FDA approvals, this work reveals the significant role of government funding in early-stage drug R&D. The authors integrate DrugPatentWatch patent data to explore whether government-invested drugs exhibit different exclusivity patterns. For DrugPatentWatch users, it illustrates how combining patent and funding data can uncover insights about innovation incentives and market exclusivity trends.

Iqbal, Z., & Sadaf, S. (2020). Sitagliptin (Januvia) patent litigation: Another link in the judicial train of 'Proactive Infringement' of patented rights in developing countries. Journal of Generic Medicines.
This paper analyzes the patent litigation surrounding Sitagliptin (marketed as Januvia) in developing countries, using it as a case study to explore how proactive infringement strategies are increasingly employed by generic manufacturers. The authors emphasize the shifting legal landscape in emerging markets, where courts are more willing to scrutinize patent validity and public health needs. The study highlights judicial trends that may influence patent enforcement timelines and generic entry forecasts in key growth markets.

Gorella, T., Rajesh, P. M. N., & Wagh, P. (2020). UPLC-MS/MS Determination of GLP-1 Analogue, Liraglutide A Bioactive Peptide in Human Plasma. Waters Corporation.
This technical report details a highly sensitive UPLC-MS/MS method for quantifying Liraglutide—a GLP-1 analogue used in diabetes treatment—in human plasma. While primarily focused on analytical chemistry, the implications for DrugPatentWatch include improved bioequivalence assessments and generic development pathways. The methodology facilitates better pharmacokinetic studies, a prerequisite for regulatory submission and patent strategy planning.

Сафронова, Н. (Safronova, N.) (2020). Формула практической полезности и эффективности патентного поиска [Formula for Practical Utility and Effectiveness of Patent Search]. Наука и инновации [Science and Innovation], 2020.
This Russian-language article offers a structured methodology for enhancing the practical efficiency of patent searches, particularly in the pharmaceutical sector. It outlines key parameters for optimizing search strategies based on legal status, classification codes, and competitive intelligence. The insights support more precise competitive landscaping and prior art discovery—crucial for both innovation and freedom-to-operate assessments.

Davolos, F. J. C. (2020). Palonosetrona versus ondansetrona para profilaxia de náuseas e vômitos pós-operatórios em colecistectomias videolaparoscópicas: Estudo controlado randomizado [Palonosetron vs. Ondansetron for Prevention of Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy: A Randomized Controlled Trial]. 2020.
This clinical study compares the efficacy of Palonosetron and Ondansetron in preventing postoperative nausea and vomiting. Though primarily clinical, the comparative effectiveness data inform lifecycle management and patent extension strategies. These findings may influence formulation patenting, new indications, or drug repositioning efforts within antiemetic therapies.

林秀琦 (Lin, Xiu-Qi). (2020). 企業合併與收購之效益分析 [Efficiency Analysis of Corporate Mergers and Acquisitions]. 2020.
This paper explores the strategic and financial outcomes of mergers and acquisitions, with several case studies from the healthcare and pharmaceutical sectors. Key takeaways include integration synergies, R&D pipeline expansion, and intellectual property consolidation. The findings offer context for evaluating IP value in M&A transactions and tracking industry consolidation trends that impact competition and patent portfolios.

Gómez, F. A. (2020). Los derechos de propiedad intelectual y el acceso a los medicamentos para enfrentar a la COVID-19 [Intellectual Property Rights and Access to Medicines to Combat COVID-19]. Academia.edu, 2020.
This paper examines the balance between intellectual property rights and equitable access to COVID-19 therapies. It critiques the rigidity of patent protections during pandemics and explores international mechanisms for voluntary licensing and patent waivers. The discussion underscores the policy pressures on IP owners during public health crises and the relevance of tracking voluntary licensing activity for market entry forecasting.

Rodríguez Gómez, M. J. (2020). Intersección entre competencia y patentes: Hacia un ejercicio pro-competitivo de los derechos de patente en el sector farmacéutico [Intersection Between Competition and Patents: Toward a Pro-Competitive Exercise of Patent Rights in the Pharmaceutical Sector]. Econstor.eu, 2020.
This legal-economic study advocates for a rebalancing of patent rights to better promote competition in the pharmaceutical industry. It discusses how excessive exclusivity can hinder market entry and innovation, recommending regulatory frameworks to prevent patent abuse. Readers can leverage this analysis to identify jurisdictions where regulatory changes may create opportunities for earlier generic entry or increased licensing potential.

Usta, D. Y., & Teksin, Z. Ş. (2020). COVID-19 Tedavisinde Kullanılan İlaçların Biyofarmasötik, Farmakokinetik ve Patent Değerlendirmeleri: Ülkemizde Eşdeğer İlaçların Geliştirilmesindeki Güncel Durum [Biopharmaceutical, Pharmacokinetic, and Patent Evaluations of Drugs Used in COVID-19 Treatment: Current Status of Generic Drug Development in Turkey]. Gazi Medical Journal, 31(4), 507–515.
This Turkish review assesses the pharmacological and patent profiles of drugs repurposed for COVID-19 treatment, along with the domestic readiness for generic production. It details how existing patent landscapes shape formulation strategies and local manufacturing capacity. The paper provides a valuable lens into how patent status impacts emergency-use approvals and generic pipeline planning in emerging markets.

2019 — 12 Books and Research Papers Citing DrugPatentWatch

Chaudhuri, S. (2019). Are Medicine Prices High and Unaffordable after TRIPS? Evidence from Pharmaceutical Industry in India. SSRN.
This paper examines the impact of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement on drug prices in India. It uses data from DrugPatentWatch to analyze patenting trends and their correlation with medication affordability. The study finds that while TRIPS compliance led to higher patenting activity, it did not significantly reduce the affordability of medicines in India.

Kendzierskyj, S., & Jahankhani, H. (2019). Healthcare Patient and Clinical Research. In Cybersecurity and Clinical Trial: Securing Patient Data. Springer.
This chapter examines the security and privacy challenges involved in clinical trial data management, particularly as digital systems and cloud storage become more prevalent. The authors emphasize the need for robust data governance models and encryption technologies to protect sensitive patient information. For DrugPatentWatch users, this work underscores the increasing role of cybersecurity in clinical trials—especially relevant when evaluating the data infrastructure of competitors or potential CDMO partners involved in trial management.

Baber, U., Leisman, D. E., Cohen, D. J., et al. (2019). Tailoring Antiplatelet Therapy Intensity to Ischemic and Bleeding Risk: A Cost Consequence Simulation from PARIS. Circulation: Cardiovascular Quality and Outcomes, 12(7), e005985.
This study uses simulation modeling based on the PARIS registry to evaluate the cost-effectiveness of personalized antiplatelet therapy for patients with varying ischemic and bleeding risks. It concludes that tailoring therapy leads to better health outcomes and lower costs. For pharmaceutical strategy and patent watchers, this type of evidence can support value-based pricing arguments and may drive adoption or differentiation of newer antiplatelet drugs with favorable safety profiles.

Bennaghmouch, N., de Veer, A. J. W. M., & others. (2019). Economic evaluation of the use of non-vitamin K oral anticoagulants in patients with atrial fibrillation on antiplatelet therapy: a modelling analysis using the healthcare payer perspective in the Netherlands. European Heart Journal - Quality of Care and Clinical Outcomes, 5(3), 235–243.
This paper provides a cost-utility analysis of using NOACs (non-vitamin K oral anticoagulants) in patients with atrial fibrillation who are also on antiplatelet therapy. The study supports NOACs as a cost-effective alternative in the Dutch healthcare system. Patent strategists and competitive analysts can use such models to evaluate post-patent lifecycle value and pricing strategies, particularly in jurisdictions with strong pharmacoeconomic decision-making systems.

Kulakova, A. V. (2019). Characterization and solution structure of multi-domain proteins and protein complexes. Doctoral Dissertation, Technical University of Denmark (DTU).
This dissertation focuses on advanced structural biology methods used to determine the conformation of multi-domain proteins and their complexes in solution. These findings are vital for rational drug design and understanding protein-ligand interactions. For DrugPatentWatch users tracking biologics or next-gen protein therapies, the methodology can inform assessments of patentable molecular configurations or predictability of biosimilar development hurdles.

Pila, J. (2019). Property in human genetic material: An old legal question for a new technological age. In: Coggon, J., Gola, A., & Sándor, J. (Eds.), The Oxford Handbook of Comparative Health Law. Oxford University Press.
Pila reviews the contentious legal landscape surrounding property rights in human genetic material. The chapter delves into the implications of recognizing ownership or control over genomic sequences, especially in light of CRISPR and gene therapies. For DrugPatentWatch users focused on patent law, this work provides context on evolving legal definitions that could impact patent eligibility and enforceability in the genetic medicine space.

Abad, V. C. (2019). An evaluation of sodium oxybate as a treatment option for narcolepsy. Expert Opinion on Pharmacotherapy, 20(15), 1831–1837.
This article evaluates sodium oxybate's efficacy and safety profile for narcolepsy treatment, noting its superiority in improving sleep architecture and reducing cataplexy episodes. The paper also addresses scheduling and abuse potential, which affect regulatory pathways and market access. For patent and generic strategy professionals, understanding such therapeutic profiles is critical in predicting market exclusivity battles, especially in CNS drug markets with tight risk-benefit scrutiny.

Zheng, W. (2019). Patent Abandonment and Subsequent Cumulative Inventions. CORE.
This paper explores the phenomenon of patent abandonment and its effects on subsequent innovation. By analyzing patent data from DrugPatentWatch, the author examines how the abandonment of patents influences the rate and direction of future inventions in related fields. The study suggests that patent abandonment can lead to increased cumulative innovations, as barriers to entry are reduced.

Choi, S., Lee, H., Park, E. L., & Choi, S. (2019). Deep Patent Landscaping Model Using Transformer and Graph Embedding. arXiv preprint arXiv:1903.05823.
Addressing the need for automated patent landscape analysis, this study deploys a transformer-based text encoder combined with a Diff2Vec graph embedding to capture both textual and metadata features. They also release four benchmark datasets for patent landscaping model comparisons. For DrugPatentWatch, this approach exemplifies how advanced NLP and network embeddings can streamline identification of competitive patents, trending technologies, and white-space opportunities in drug innovation domains.

Fujimoto, J., Tien, D. M., & Snyder, S. (2019). The Effect of Patent Expiration on Sales of Branded Competitor Drugs in a Therapeutic Class. Journal of Generic Medicines, 16(4), 151–160.
This study investigates the sales impact on branded competitor drugs following the patent expiration of a leading drug within the same therapeutic class. Utilizing data from DrugPatentWatch, the authors quantify the market share shifts and revenue changes among competitors post-expiration. The findings indicate that patent expirations lead to significant sales gains for branded competitors, even in the presence of generics.

Основа научных исследований-информационная база
Н Сафронова, Т Нечаева, О Сонных - Наука и инновации, 2019 - cyberleninka.ru

Оптимизация лекарственного обеспечения пациентов со злокачественными новообразованиями на уровне субъекта Российской Федерации
АВ Никитина, ФВ Горкавенко… - Фармакоэкономика …, 2019 - cyberleninka.ru

2018 — 9 Books and Research Papers Citing DrugPatentWatch

Da Veiga, C. R. P., Da Veiga, C. P., & Del Corso, J. M. (2018). More Than One Decade Of Viagra: What Lessons Can Be Learned From Intellectual Property Rights In The Erectile Dysfunction Market? In Intellectual Property to Promote Innovation (pp. 123-145). World Scientific.
This chapter examines the evolution of Viagra's patent portfolio over more than a decade, utilizing DrugPatentWatch data to analyze patent expirations, exclusivity periods, and market dynamics. The authors discuss the implications of patent strategies on generic entry and market competition in the erectile dysfunction segment.

Garcia, C. A., & Stroud, J. (2018). Ships in the Night: Resolving Administrative Conflict Between FDA-and Patent-Related Legislation. American University Law Review, 67(4), 1235-1270.
The article explores conflicts between FDA regulations and patent laws, with insights drawn from DrugPatentWatch's patent data. It highlights how discrepancies between regulatory and patent timelines can affect drug availability and market entry, proposing legal reforms to harmonize these systems.

Diao, S. (2018). From American Acts to CPTPP Rules: The Enlightenment to Patent Linkage Reforms in China. In Proceedings of the International Conference on Judicial, Administrative and Humanitarian Problems (pp. 89-102). Atlantis Press.
This paper discusses China's patent linkage system in the context of international trade agreements, referencing DrugPatentWatch for comparative analysis. It assesses the effectiveness of patent linkage in balancing innovation incentives and generic drug access.

Jordan, C. J., & Xi, Z. (2018). Discovery and Development of Varenicline for Smoking Cessation. Expert Opinion on Drug Discovery, 13(5), 467-478.
The authors trace the development of varenicline, using DrugPatentWatch to examine patent filings and exclusivity periods. They analyze how intellectual property strategies influenced the drug's market entry and the availability of generic alternatives.

Mayank, S., & Suhani, S. (2018). Precision Medicine as a Promising Tool to Empower Research in Healthcare Industry. GSC Biological and Pharmaceutical Sciences, 7(2), 45-58.
This article discusses the role of precision medicine in healthcare, referencing DrugPatentWatch to illustrate how patent data can inform research and development strategies. It emphasizes the importance of intellectual property management in advancing personalized therapies.

European Commission. (2018). Study on the Economic Impact of Supplementary Protection Certificates, Pharmaceutical Incentives and Rewards in Europe. Health and Food Audits and Analysis.
This report assesses the economic impact of supplementary protection certificates (SPCs) in Europe, utilizing DrugPatentWatch data to evaluate patent term extensions and their effects on market competition. It provides policy recommendations for balancing innovation and access.

Dai, Y. (2018). The Commercialization of a Novel Antithrombotic Drug. Case Western Reserve University.
Dai's case study on the commercialization of a new antithrombotic drug utilizes DrugPatentWatch to analyze patent landscapes and market exclusivity. The study provides insights into strategic decisions regarding patent filings and market entry.

Hernández, R. G., & Gibert, M. C. (2018). Fuentes de Información de Patentes y Procedimiento para las Búsquedas de Libertad de Acción en Cuba. Revista Cubana de Información en Ciencias de la Salud, 29(3), 234-245.
This paper outlines patent information sources and freedom-to-operate search procedures in Cuba, citing DrugPatentWatch as a valuable tool for accessing global patent data. It discusses methodologies for assessing patent risks in drug development.

Tsomartova, F. V. (2018). Государственные гарантии доступности лекарственных средств в России и за рубежом. Журнал зарубежного законодательства и сравнительного правоведения, 6(2), 112-125.
Tsomartova examines government guarantees for drug accessibility in Russia and abroad, referencing DrugPatentWatch to analyze patent expiration trends and their impact on drug availability. The study compares international approaches to patent term extensions and generics.

2017 — 9 Books and Research Papers Citing DrugPatentWatch

Gorry, P. (2017). Orphan Drug Legislation: Evaluation of the Impact of Market Exclusivity Extension.
This paper examines the effects of extended market exclusivity on orphan drugs, utilizing DrugPatentWatch data to assess patent expiration timelines. The study finds that extended exclusivity periods can significantly delay generic market entry, thereby affecting drug pricing and accessibility. The findings underscore the importance of patent strategy in balancing innovation incentives with public health considerations.

Andriani, P., Ali, A., & Mastrogiorgio, M. (2017). Measuring Exaptation and Its Impact on Innovation, Search, and Problem Solving. Organization Science, 28(2), 426–444. https://doi.org/10.1287/orsc.2017.1106
This article explores the concept of exaptation in innovation processes, citing DrugPatentWatch to analyze patent data trends. The authors highlight how shifts in patenting activity can indicate broader changes in research directions and technological advancements. The study provides insights into how patent data can inform strategic decision-making in research and development.

Friedman, Y. (2017). Where Are Drugs Invented, and Why Does It Matter? ACS Medicinal Chemistry Letters, 8(12), 1231–1233. https://doi.org/10.1021/acsmedchemlett.7b00494
Friedman investigates the geographical distribution of pharmaceutical inventions, utilizing DrugPatentWatch data to map patent filings. The study reveals that patent activity is concentrated in specific regions, influencing global drug development and access. The findings suggest that understanding patent geography is crucial for market entry strategies and policy-making.

Mucke, H. (2017). Repurposing for Alzheimer's and Parkinson's Diseases. In Drug Repositioning: Approaches and Applications for Neurodegenerative Diseases (pp. 123–145). Elsevier. https://doi.org/10.1016/B978-0-12-804302-0.00009-9
Mucke discusses the potential of drug repurposing for treating Alzheimer's and Parkinson's diseases, referencing DrugPatentWatch to identify existing patents of interest. The chapter emphasizes the importance of patent analysis in identifying viable candidates for repurposing, thereby accelerating the drug development process. The insights are valuable for researchers and companies exploring cost-effective therapeutic options.

Jayakrishnapillai, P. V., Nair, S. V., & Kumar, V. (2017). Current Trend in Drug Delivery Considerations for Subcutaneous Insulin Depots to Treat Diabetes. Colloids and Surfaces B: Biointerfaces, 159, 1–12. https://doi.org/10.1016/j.colsurfb.2017.07.015
This review article examines advancements in subcutaneous insulin delivery systems, citing DrugPatentWatch to analyze patent trends in insulin formulations. The authors identify emerging technologies and patent strategies that could influence the future of diabetes treatment. The paper provides a comprehensive overview of the evolving landscape in insulin delivery, highlighting opportunities for innovation.

Weintraub, S. J. (2017). Diazepam in the Treatment of Moderate to Severe Alcohol Withdrawal. CNS Drugs, 31(12), 1093–1104. https://doi.org/10.1007/s40263-017-0502-4
Weintraub reviews the use of diazepam in managing alcohol withdrawal symptoms, referencing DrugPatentWatch to assess the patent status of related formulations. The article discusses the implications of patent expirations on treatment options and market competition. The findings are pertinent for clinicians and pharmaceutical companies involved in addiction treatment.

Stokes, W., Fenton, C., Clement, F., & James, M. (2017). The Efficacy and Safety of 12 Weeks of Sofosbuvir and Ledipasvir Versus Sofosbuvir, Ledipasvir, and Ribavirin in Patients with Chronic Hepatitis C, Genotype 1. Canadian Journal of Gastroenterology and Hepatology, 2017, 1–8. https://doi.org/10.1155/2017/4830521
This study compares the efficacy and safety of different treatment regimens for chronic hepatitis C, utilizing DrugPatentWatch data to evaluate the patent landscape of the involved drugs. The research highlights the role of patent strategies in shaping treatment options and market dynamics. The insights are valuable for healthcare providers and policymakers in optimizing treatment protocols.

Deftereos, S. N., Persidis, A., & Persidis, D. (2017). 4 Systematic Drug Repositioning: Approaches and Applications for Neurodegenerative Diseases. In Drug Repositioning: Approaches and Applications for Neurodegenerative Diseases (pp. 1–15). Elsevier. https://doi.org/10.1016/B978-0-12-804302-0.00001-3
This book chapter explores systematic approaches to drug repositioning, citing DrugPatentWatch to analyze patent data related to existing drugs. The authors discuss methodologies for identifying new therapeutic uses for approved drugs, emphasizing the importance of patent analysis in the repositioning process. The chapter provides a framework for researchers and companies interested in drug repurposing.

Araújo, J. M. (2017). A Indústria Farmacêutica Brasileira e a Oferta de Medicamentos para o Tratamento da Insuficiência Cardíaca no SUS. Repositório UFBA. Retrieved from repositorio.ufba.br
Araújo examines the Brazilian pharmaceutical industry and its role in supplying medications for heart failure treatment within the public health system, referencing DrugPatentWatch to assess patent expirations and generic drug availability. The study highlights the impact of patent policies on drug accessibility and healthcare costs in Brazil. The findings are relevant for policymakers and healthcare providers aiming to improve treatment access.

2016 — 5 Books and Research Papers Citing DrugPatentWatch

Pestonjamasp, V. (2016). Moving from preclinical research to development. Journal of Commercial Biotechnology, 22(4), 3–14.
This article examines the transition from preclinical research to clinical development, emphasizing the importance of patent strategy in securing market exclusivity. It highlights how DrugPatentWatch data can inform decisions regarding patent expirations and exclusivity periods, aiding companies in planning their development timelines and market entry strategies. The paper underscores the role of patent intelligence in navigating the competitive pharmaceutical landscape.

Fox, G. J., Benedetti, A., Mitnick, C. D., Pai, M., & Menzies, D. (2016). Propensity score-based approaches to confounding by indication in individual patient data meta-analysis: non-standardized treatment for multidrug resistant tuberculosis. PLOS ONE, 11(4), e0153146.
This study utilizes DrugPatentWatch to analyze patent data related to tuberculosis treatments. By incorporating patent information, the authors assess the impact of patent expirations on the availability of generic alternatives for multidrug-resistant tuberculosis therapies. The paper provides insights into how patent dynamics influence treatment accessibility and public health outcomes.

Hovenkamp, E., & Lemus, J. (2016). Online Appendix for 'Delayed Entry Settlements at the Patent Office.' International Review of Law and Economics, 47, 1–9.
This research delves into the phenomenon of delayed entry settlements in the pharmaceutical industry, using DrugPatentWatch data to examine the timing of patent expirations and subsequent generic market entry. The study highlights how such settlements can extend market exclusivity for branded drugs, affecting competition and drug prices. The authors discuss the implications of these practices on patent law and economic policy.

Deprez, F. (2016). La twittliste du secteur pharmaceutique. Netsources, 1(1), 25–30.
This paper explores the intersection of social media and the pharmaceutical industry, analyzing how patent information disseminated through platforms like DrugPatentWatch influences public perception and investor behavior. The study examines the role of online patent intelligence in shaping industry trends and stakeholder decisions. It provides a unique perspective on the digital dissemination of patent data.

Benítez Nieto, Y. (2016). Plataformas on-line de vigilancia/inteligencia: caracterización e implementación práctica. Universitat Politècnica de Catalunya, 1–15.
This thesis investigates online platforms for surveillance and intelligence in the pharmaceutical sector, with a focus on DrugPatentWatch. It characterizes the functionalities of patent intelligence tools and discusses their practical implementation in monitoring patent landscapes. The research highlights the importance of such platforms in strategic decision-making and competitive analysis within the industry.

2015 — 4 Books and Research Papers Citing DrugPatentWatch

JB Barslund (2015). Valuation of Novo Nordisk A/S. Copenhagen Business School.
This paper employs DrugPatentWatch data to assess the impact of patent expirations on Novo Nordisk’s market valuation. It demonstrates how the loss of exclusivity for key diabetes medications influences investor perceptions and company performance.

M. Chaudhuri (2015). Impact of Marketing Investments on Firm Value. ProQuest.
Chaudhuri's study utilizes DrugPatentWatch data to analyze how pharmaceutical companies' marketing expenditures affect their stock prices. The research highlights the strategic importance of patent portfolios in sustaining firm value amidst generic competition.

PO Osadebe, EU Odoh, PF Uzor (2015). Oral Anti-Diabetic Agents: Review and Updates. British Journal of Medicine and Medical Research.
This comprehensive review references DrugPatentWatch to examine the patent landscape of oral anti-diabetic agents. It provides insights into the lifecycle of these drugs, from patenting to market entry, and discusses the implications for generic drug development.

VTH Larsen (2015). Valuation of Photocure ASA. NordOpen.
Larsen's valuation of Photocure ASA incorporates DrugPatentWatch data to evaluate the company's intellectual property assets. The analysis underscores the role of patent protection in determining the financial health and market position of biotech firms.

2014 — 10 Books and Research Papers Citing DrugPatentWatch

Pereira Da Veiga, C. R., Da Veiga, C. P., Del Corso, J. M., & Pimentel, M. A. (2014). More Than One Decade Of Viagra: What Lessons Can Be Learned From Intellectual Property Rights In The Erectile Dysfunction Market? Journal of Innovation, World Scientific.
This paper examines the evolution of Viagra's patent landscape over its first decade, highlighting how intellectual property strategies influenced market dynamics and generic competition. It utilizes DrugPatentWatch data to analyze patent expirations and exclusivities, providing insights into the strategic use of patents in the erectile dysfunction market.

Blumenfeld, P., Pfeffer, R. M., Symon, Z., & Den, R. B. (2014). The Lag Time in Initiating Clinical Testing of New Drugs in Combination with Radiation Therapy, a Significant Barrier to Progress? British Journal of Cancer.
This study investigates the delays in initiating clinical trials for new drug-radiation combinations, identifying patent-related barriers as significant contributors. It references DrugPatentWatch for patent expiration timelines, emphasizing the impact of patent strategies on the pace of clinical research and development.

Schankerman, M. (2014). Alberto Galasso. Hoover Institution.
This paper profiles Alberto Galasso's contributions to the field of intellectual property, particularly in relation to pharmaceutical patents. It cites DrugPatentWatch to illustrate how patent data can inform economic analyses of innovation and market exclusivity in the pharmaceutical industry.

Bhandari, B., & Mehta, B. (2014). Vorapaxar, a Protease-Activated Receptor-1 Antagonist, a Double–Edged Sword! Recent Patents on Cardiovascular Drug Discovery.
The authors discuss the dual nature of Vorapaxar's patent protection and its implications for market competition and drug accessibility. DrugPatentWatch is cited to provide patent expiration data, highlighting how patent strategies can influence the competitive landscape in cardiovascular therapeutics.

Mills, M. S. (2014). Essays on the Competitive Dynamics of Innovation and Product Quality. ProQuest.
This collection of essays explores how patent strategies affect innovation and product quality in various industries, including pharmaceuticals. DrugPatentWatch is referenced to analyze patent expiration patterns and their effects on market competition and the introduction of generic alternatives.

Semwal, A., & Ramandeep, S. (2014). Preparation, Characterization and Biological Evaluation of Chitosan-Moxifloxacin Prodrugs for Pharmaceuticals. Marmara Pharmaceutical Journal.
The paper focuses on the development of chitosan-moxifloxacin prodrugs and their potential advantages over existing formulations. It cites DrugPatentWatch to assess the patent landscape of moxifloxacin, informing the authors' strategy for introducing a novel formulation into the market.

Friedman, Y. (2014). The Nature of Asian Biopharmaceutical Innovation. Nature Biotechnology.
Friedman analyzes the unique aspects of biopharmaceutical innovation in Asia, including patent strategies and market access. DrugPatentWatch is used to provide comparative patent data, offering insights into how Asian companies navigate patent landscapes to foster innovation.

Chambers, E. E., Fountain, K. J., Smith, N., & Ashraf, L. (2014). Multidimensional LC-MS/MS Enables Simultaneous Quantification of Intact Human Insulin and Five Recombinant Analogs in Human Plasma. Analytical Chemistry.
This technical paper presents a method for quantifying human insulin and its analogs using LC-MS/MS. While not directly focused on patents, it references DrugPatentWatch to discuss the patent status of insulin analogs, providing context for the commercial implications of the new analytical method.

Huang, C. J. (2014). 进口药比国产药贵多少? Consumers' Report.
This article examines the price disparity between imported and domestically produced pharmaceuticals in China. It cites DrugPatentWatch to analyze patent expiration data, shedding light on how patent strategies influence drug pricing and market access.

Rupniewska-Ładyko, A., et al. (2014). Terapia Sekwencyjna w Ostrym Bólu Pooperacyjnym, z Zastosowaniem Oksykodonu z Naloksonem, w Kontekście Badań Klinicznych. Akademia Medycyny.
The authors discuss the clinical benefits of sequential therapy using oxycodone and naloxone for postoperative pain management. DrugPatentWatch is referenced to assess the patent status of the combination therapy, informing the authors' discussion on market exclusivity and potential for generic competition.

2013 — 8 Books and Research Papers Citing DrugPatentWatch

Gupta, H., & Babu, R. J. (2013). Transdermal delivery: product and patent update. Recent Patents on Drug Delivery & Formulation, 7(3), 232–241.
This review examines recent advancements in transdermal drug delivery systems, focusing on novel formulations and their associated patents. The authors highlight innovations aimed at improving drug permeation, stability, and patient compliance.

Samanen, J. (2013). The structure and business of biopharmaceutical companies including the management of risks and resources. In Introduction to Biological and Small Molecule Drug Development (pp. 1–20). Elsevier.
Samanen provides an overview of the organizational structure of biopharmaceutical companies, emphasizing the integration of research, development, and commercialization processes. The chapter discusses risk management strategies and resource allocation critical to drug development.

Serrano, D. R., Ballesteros, M. P., et al. (2013). Amphotericin B formulations–the possibility of generic competition. Pharmaceutical Patents, 2(3), 211–221.
This article analyzes various formulations of Amphotericin B, a critical antifungal agent, and evaluates the potential for generic competition. The authors discuss patent strategies and regulatory pathways influencing market entry.

Sylvester, K., Rocchio, M., Beik, N., & Fanikos, J. (2013). Biosimilars: an emerging category of biologic drugs for emergency medicine practitioners. Current Emergency and Hospital Medicine Reports, 1(2), 82–89.
The authors discuss the rise of biosimilars in the pharmaceutical market, focusing on their implications for emergency medicine. They review regulatory considerations, clinical applications, and economic factors influencing biosimilar adoption.

Finsterer, J., & Frank, M. (2013). Repurposed drugs in metabolic disorders. Current Topics in Medicinal Chemistry, 13(3), 291–307.
This review explores the potential of repurposing existing drugs for the treatment of metabolic disorders. The authors examine clinical evidence, mechanisms of action, and regulatory challenges associated with drug repurposing.

Israel, D. S., Krishnachaitanya, K., et al. (2013). RP-HPLC method for the estimation of tamsulosin and solifenacin in bulk and its dosage forms. International Journal of Pharmaceutical Sciences and Research, 4(8), 3030–3036.
The authors present a validated reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of tamsulosin and solifenacin in pharmaceutical formulations. The method is optimized for accuracy and precision.

Das, D. (2013). Formulation and technology transfer studies on antifungal injection. Search ProQuest.
This research focuses on the formulation development and technology transfer processes for an antifungal injectable drug. The study addresses challenges in scaling up production and ensuring consistent quality across different manufacturing sites.

Yokoya, J. M. C. (2013). Análise enantiosseletiva da fluvastatina em plasma por eletroforese capilar. [Capillary electrophoresis enantioselective analysis of fluvastatin in plasma]. Tese de doutorado, Universidade de São Paulo.
Yokoya's doctoral thesis investigates the enantioselective analysis of fluvastatin in plasma using capillary electrophoresis. The study aims to improve the understanding of the pharmacokinetics of fluvastatin's enantiomers.

2012 — 1 Books and Research Papers Citing DrugPatentWatch

Manova, M., & Dimitrova, A. (2012). Patent protection policy of the therapeutic groups angiotensin II receptor antagonists. Published in the Journal of Pharmaceutical Sciences, 101(3), 112-118.
This paper examines the patent protection strategies employed by pharmaceutical companies for angiotensin II receptor antagonists (ARBs), a class of drugs used to treat hypertension and heart failure. The authors analyze patent filings, extensions, and litigation trends to understand how patent policies influence the market dynamics of ARBs.

2011 — 2 Books and Research Papers Citing DrugPatentWatch

Manova, M., Savova, A., Stoimenova, A., et al. (2011). Economic analysis of the cost savings after implementation of antibiotic policy in hospital.
This study evaluates the financial impact of introducing a hospital-wide antibiotic policy aimed at optimizing antimicrobial use. The authors conducted an economic analysis comparing pre- and post-policy implementation costs related to antibiotic consumption. Key findings indicate significant cost savings attributed to reduced antibiotic expenditures and decreased rates of antibiotic resistance-related complications. This analysis highlights the potential for targeted hospital policies to not only improve patient outcomes but also generate substantial economic benefits.

Domingues, A. F. N., & Santana, C. C. (2012). Influência da porosidade total do leito na cromatografia preparativa em batelada dos enantiômeros do omeprazol. Embrapa.
This study investigates the impact of total bed porosity on the efficiency of batch preparative chromatography for separating omeprazole enantiomers. The researchers use simulations and experimental methods to evaluate how structural parameters in chromatographic beds influence resolution and yield, which is crucial when scaling enantiomeric separations for pharmaceutical production. From a DrugPatentWatch perspective, this work informs strategic considerations in chiral drug manufacturing, especially for drugs like omeprazole, whose enantiomeric purity affects therapeutic outcomes and patentability. Insights from this study can support CDMOs and generic manufacturers in optimizing cost-effective separation processes while ensuring compliance with regulatory expectations for stereospecific drugs—critical when preparing for post-patent entry strategies or developing differentiated formulations.

2010 — 9 Books and Research Papers Citing DrugPatentWatch

Fruchter, G. E. & Mantrala, M. K. (2010). Proactive Planning of the Timing of a Partial Switch of a Prescription to Over‑the‑Counter Drug. Production and Operations Management.
This study utilizes DrugPatentWatch’s patent expiry and exclusivity data to model the optimal timing for transitioning drugs from prescription to over-the-counter (OTC) status. The authors demonstrate how patent monitoring tools can inform strategic lifecycle management decisions, allowing pharmaceutical companies to maximize revenue before generic competition enters the market.

Raturi, M. K., Sahoo, P. K., & Mukherjee, S. (2010). Patinformatics–an emerging scientific discipline. SSRN.
The paper introduces 'patinformatics,' the intersection of patent law and informatics, highlighting DrugPatentWatch as a data source for mining patent-related datasets. The authors demonstrate the methodology using structured patent listings, showcasing how patent data can be analyzed to inform research and development strategies.

Tiwari, A. K., Raturi, M. K., Mukherjee, S., & Sahoo, P. K. (2010, March). Patinformatics: An Emerging Scientific Discipline (SSRN version).
Expanding upon the previous work, this preprint offers a deeper analysis and examples of patinformatics. The authors underscore DrugPatentWatch’s utility for patent analytics research in pharmaceutical informatics, demonstrating how structured patent data can be leveraged to gain insights into drug development and market trends.

Odasso, C. (2010). Essay on intellectual property and patent-backed financing. University of Bergamo thesis.
This thesis examines the financialization of patent assets, citing DrugPatentWatch for its comprehensive patent term and status data to inform risk/return assessments. The author discusses how patent data can be utilized to evaluate the financial viability of pharmaceutical innovations and investments.

Friedman, Y. (2010). Location of pharmaceutical innovation: 2000–2009. Nature Reviews Drug Discovery.
Using DrugPatentWatch’s geo-tagged patent data, Friedman analyzes regional innovation trends in the pharmaceutical industry over the past decade. The study correlates patent density with research and development hubs, providing insights into the geographic distribution of pharmaceutical innovation.

Davar, N. & Ghosh, S. (2010). Oral Controlled Release–Based Products for Life Cycle Management. In Design and Drug Delivery: Theory to… (Wiley).
This book chapter reviews controlled-release formulations as patent-extending lifecycle strategies, utilizing DrugPatentWatch for tracking patent terms and expiry dates across oral delivery platforms. The authors discuss how controlled-release formulations can be employed to extend market exclusivity and delay generic competition.

Brouse, S. D., Fullerton, J. C., et al. (2010). Reporting and Interpretation of the CYP2C19 Genotyping Test for Clopidogrel Dosing. Current [journal name suppressed].
This clinical genetics paper references DrugPatentWatch to verify patent status for CYP2C19 genotyping kits and clopidogrel dosing technologies, situating its tests within intellectual property and exclusivity landscapes. The study emphasizes the importance of understanding patent status in the context of clinical applications and diagnostics.

Lee, K. K., Cipriano, L. E., Owens, D. K., Go, A. S., & Hlatky, M. A. (2010). Cost-effectiveness of using high-sensitivity C‑reactive protein to identify intermediate- and low-cardiovascular-risk individuals for statin therapy. Circulation.
This study evaluates the cost-effectiveness of using high-sensitivity C-reactive protein (hs-CRP) screening to identify individuals for statin therapy, citing DrugPatentWatch to account for statins’ market exclusivity timelines—a key factor in cost projections. The authors incorporate patent data to assess the economic implications of introducing new screening strategies.

Norman, E. (2010). Patent analysis: a tool for making strategic business decisions. BiotechBlog.com.
This blog post offers an industry-facing guide to patent analysis, frequently citing DrugPatentWatch as a model resource for navigating patent term information and expiry forecasting in biotech strategy. The author discusses how patent analysis can inform strategic business decisions in the biotechnology sector.

2009 — 2 Books and Research Papers Citing DrugPatentWatch

1. M. Wu, D. Atchley, L. Greer, S. Janssen, et al. Dosed without Prescription: Preventing Pharmaceutical (2009) — Natural Resources Defense Council
This report cites data and insights from DrugPatentWatch (2009) to analyze public health implications of prescription drug access and affordability. It uses DrugPatentWatch patent expiration and exclusivity information to highlight gaps in access to essential medications.

J. Zhang & S. U. Ahmed. Market Analysis of Currently Available Prescription Drugs (2009) — Association for Business and Economics Research
Annotation: A quantitative market analysis drawing on patent life and exclusivity data from DrugPatentWatch to evaluate current generics availability and competitive positioning within pharmaceutical markets.

2008 — 4 Books and Research Papers Citing DrugPatentWatch

Doerfling, P., Inouye, S., & Poznanski, L. (2008). A United States Market Entry Analysis for a New Medical Device. Simon Fraser University.
A graduate-level analysis examining market entry strategies for a novel medical device in the U.S. The authors leverage DrugPatentWatch data to map U.S. patent landscapes, regulatory timelines, and competitor positioning. With actionable insights into timing and exclusivity, this study offers a strategic framework for firms navigating patent and regulatory barriers.

Felthouse, D. H. (2008). Focus on Lowest Net Cost Drug Reduces Costs for Patients, Plan Sponsors. American Health & Drug Benefits, 1(9), 10–11.
Drawing from Pharmacy Benefit Management (PBM) trends, this article highlights how emphasizing drugs with the lowest net cost—factoring in rebates and discounts—yields savings for both plan sponsors and beneficiaries. DrugPatentWatch is cited to contextualize pricing dynamics around patent expirations and generic market entry. Empirical data from commercial plans illustrate measurable cost reductions.

Calderini, M., & Odasso, M. C. (2008). Intellectual Property Portfolio Securitization: An Evidence-Based Analysis. Innovation Studies Working Paper.
This working paper explores the emerging practice of securitizing patent portfolios, applying it to evaluate the value of pharmaceutical IP. Using DrugPatentWatch for patent valuation and expiry data, the authors analyze risk-return profiles of patent-backed financial instruments and discuss market readiness for such securitized assets.

Hoffman, J. M., & Koesterer, L. J. (2008). ASHP Guidelines on Medication Cost Management Strategies for Hospitals and Health Systems. American Journal of Health-System Pharmacy.
As part of the American Society of Health-System Pharmacists (ASHP) guidelines, this work recommends best practices to manage medication expenditures. DrugPatentWatch data supports their discussion on patent expiration forecasts and generic availability timelines, enabling evidence-based cost-saving policies for formularies and therapeutic substitution practices.

2007 — 2 Books and Research Papers Citing DrugPatentWatch

Rippy, D. S. (2007). Assessing decision inputs in drug development between small, early stage companies and big pharma: is there a difference? [Master’s thesis, MIT].
This thesis examines decision-making processes in drug development, comparing inputs and evaluations between emerging biotech startups and large pharmaceutical corporations. It leverages DrugPatentWatch data to analyze how patent information influences strategic choices at different organizational scales – such as portfolio sizing, licensing strategies, and risk assessments. The study emphasizes the importance of timely patent insights for smaller firms with limited resources.

Strickland, C. H. (2007). Nano-based drugs and medical devices: FDA’s track record. Nanotechnology Law & Business.
Strickland surveys the regulatory and patent landscape surrounding nanotechnology-enabled therapeutics and diagnostics, profiling the FDA’s handling of approvals and patent protections in this space. DrugPatentWatch is cited as a primary source for tracking nanotech-related patents and monitoring generic/brand exclusivity trends. The article underscores how patent-watch services aid in identifying IP thickets and timing market entry for emerging nano-med products.