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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.
