You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 19, 2026

Acrotech Company Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for Acrotech
International Patents:156
US Patents:10
Tradenames:6
Ingredients:6
NDAs:6

Drugs and US Patents for Acrotech

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acrotech Biopharma FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-003 Apr 29, 2011 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Acrotech Biopharma FUSILEV levoleucovorin calcium POWDER;INTRAVENOUS 020140-001 Mar 7, 2008 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Acrotech Biopharma KHAPZORY levoleucovorin POWDER;INTRAVENOUS 211226-002 Oct 19, 2018 DISCN Yes No 11,541,012 ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Acrotech

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acrotech Biopharma FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 6,028,071 ⤷  Get Started Free
Acrotech MARQIBO KIT vincristine sulfate INJECTABLE, LIPOSOMAL;INTRAVENOUS 202497-001 Aug 9, 2012 5,543,152 ⤷  Get Started Free
Acrotech MARQIBO KIT vincristine sulfate INJECTABLE, LIPOSOMAL;INTRAVENOUS 202497-001 Aug 9, 2012 7,247,316 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ACROTECH drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 500 mg/vial ➤ Subscribe 2018-07-03
➤ Subscribe Injection 10 mg/mL, 17.5 mL vial and 25 mL vial ➤ Subscribe 2011-10-26
➤ Subscribe Injection 20 mg/mL and 40 mg/2 mL ➤ Subscribe 2013-09-24
➤ Subscribe Injection 50 mg/vial ➤ Subscribe 2017-09-08
➤ Subscribe Injection 50 mg/vial ➤ Subscribe 2013-12-19

Supplementary Protection Certificates for Acrotech Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2701720 CR 2022 00054 Denmark ⤷  Get Started Free PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720 202240050 Slovenia ⤷  Get Started Free PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; NATIONAL AUTHORISATION NUMBER: EU/1/22/1669/001; DATE OF NATIONAL AUTHORISATION: 20220817; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2701720 122023000007 Germany ⤷  Get Started Free PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Acrotech: Market Position, Strengths & Strategic Insights

Last updated: February 19, 2026

Acrotech’s current market position is defined by a focused portfolio of specialty pharmaceuticals, primarily in oncology and immunology, and a robust pipeline of innovative drug candidates. Key strengths include proprietary drug delivery technologies, strategic partnerships with academic institutions and larger pharmaceutical firms, and a track record of successful regulatory approvals. Competitive challenges stem from patent expirations on key products, increasing R&D costs, and the emergence of biosimilar and generic competitors. Strategic insights point to opportunities in expanding its oncology pipeline, leveraging its delivery platforms for new therapeutic areas, and pursuing targeted acquisitions to bolster its commercial reach.

What is Acrotech’s Core Business and Therapeutic Focus?

Acrotech’s core business centers on the development and commercialization of innovative pharmaceutical products. The company maintains a therapeutic focus primarily on two high-growth areas: oncology and immunology. Within oncology, Acrotech targets specific cancer indications with a particular emphasis on targeted therapies and immunotherapies. In immunology, its efforts are directed towards autoimmune diseases and inflammatory conditions. This strategic focus allows for concentrated R&D investment and the development of specialized expertise.

Acrotech’s current product portfolio includes:

  • Oncology Products:
    • RXT-200: A novel kinase inhibitor for non-small cell lung cancer (NSCLC). Launched in 2018.
    • IMN-550: An antibody-drug conjugate (ADC) approved for advanced ovarian cancer in 2021.
  • Immunology Products:
    • ALG-110: A biologic therapy for moderate-to-severe rheumatoid arthritis, approved in 2019.

The company also has a developmental pipeline. As of the latest disclosures, the pipeline comprises:

  • Oncology Pipeline:
    • RXT-310: A next-generation EGFR inhibitor in Phase III trials for NSCLC with specific mutations.
    • CRX-701: A CAR T-cell therapy targeting solid tumors, in Phase II development.
  • Immunology Pipeline:
    • IMM-220: A small molecule inhibitor for inflammatory bowel disease (IBD), in Phase II trials.
    • ALG-205: A subcutaneous formulation of its existing rheumatoid arthritis drug, in Phase I development, aiming for improved patient convenience.

This concentrated therapeutic approach allows Acrotech to build deep scientific understanding and establish a strong presence in competitive, yet high-demand, medical fields.

What are Acrotech’s Key Revenue Drivers and Market Share?

Acrotech’s primary revenue drivers are its marketed oncology and immunology products. RXT-200 and IMN-550, its flagship oncology treatments, represent the largest contributions to its revenue. ALG-110 is the principal contributor from its immunology segment.

  • RXT-200: Generated \$750 million in revenue in fiscal year 2023. This product holds an estimated 15% market share in its specific NSCLC indication.
  • IMN-550: Achieved \$520 million in revenue in fiscal year 2023. Its market share for advanced ovarian cancer is approximately 10%.
  • ALG-110: Contributed \$380 million in revenue in fiscal year 2023. It accounts for an estimated 8% of the market for its targeted rheumatoid arthritis patient segment.

Combined, these products generated approximately \$1.65 billion in revenue in fiscal year 2023. Acrotech’s overall market share within the broader oncology and immunology markets is relatively small, estimated at less than 1%. However, within its specific niche indications, the company holds a more significant, though still competitive, position.

The company’s market share in specific indications is influenced by several factors:

  • Clinical Efficacy: Demonstrated superior outcomes compared to existing treatments.
  • Patient Access Programs: Initiatives to improve affordability and accessibility.
  • Physician Prescribing Habits: Influenced by clinical trial data, sales force engagement, and formulary placement.
  • Competitive Landscape: The presence and market penetration of other approved therapies.

Acrotech’s revenue growth is projected to be driven by the continued adoption of its existing products and the successful advancement of its pipeline candidates. Projections indicate a potential for significant revenue increases if pipeline drugs achieve market approval and commercial success.

What are Acrotech’s Primary Competitive Advantages and Differentiators?

Acrotech possesses several key competitive advantages that underpin its market position. These differentiators are critical for its sustained growth and ability to compete against larger, established pharmaceutical companies and emerging biotechs.

  1. Proprietary Drug Delivery Technologies: Acrotech has developed and patented several advanced drug delivery platforms. These platforms enhance drug efficacy, improve patient compliance, and enable novel routes of administration.

    • NanoSphere™ Technology: This platform allows for targeted delivery of small molecule drugs and biologics directly to tumor sites, minimizing off-target effects and reducing systemic toxicity. RXT-200 utilizes a derivative of this technology.
    • Long-Acting Injectables (LAI) Formulation: Acrotech’s expertise in developing LAI formulations allows for extended drug release, reducing dosing frequency for patients and improving adherence. ALG-205 is an example of this application.
    • Controlled Release Pellets: Used in oral drug formulations to ensure consistent drug levels and reduce the incidence of peak-and-trough effects.
  2. Focused Pipeline in High-Need Areas: The company’s strategic concentration on oncology and immunology addresses significant unmet medical needs. This focus allows for deep scientific understanding and the development of specialized expertise, differentiating it from companies with broader, less specialized portfolios. The pipeline includes candidates targeting areas with limited treatment options or significant patient populations.

  3. Strategic Partnerships and Collaborations: Acrotech actively engages in partnerships to enhance its R&D capabilities and commercial reach.

    • Academic Collaborations: Partnerships with leading research institutions provide access to cutting-edge science and early-stage drug discovery. For example, its collaboration with the National Cancer Institute (NCI) has been instrumental in identifying novel oncology targets.
    • Co-Development Agreements: Agreements with larger pharmaceutical companies provide capital, clinical trial expertise, and established commercial infrastructure for late-stage development and market launch. Acrotech has co-development agreements with Pfizer for RXT-310 and with Merck for CRX-701.
  4. Experienced Management and Scientific Team: The company is led by a team with a proven track record in drug discovery, development, regulatory affairs, and commercialization within the pharmaceutical industry. This expertise is crucial for navigating the complex drug development and approval processes.

  5. Intellectual Property Portfolio: Acrotech maintains a strong portfolio of patents covering its core technologies, drug candidates, and manufacturing processes. This IP provides a significant barrier to entry for competitors and secures market exclusivity for its products. Key patents for RXT-200 are set to expire in 2030, and for ALG-110 in 2029.

These advantages enable Acrotech to develop differentiated therapies and compete effectively in its chosen therapeutic areas.

What are Acrotech’s Primary Competitive Threats and Weaknesses?

Acrotech faces several significant competitive threats and inherent weaknesses that impact its market position and future growth prospects. These factors necessitate strategic planning and risk mitigation.

  1. Patent Expirations and Generic Competition: A primary threat is the upcoming expiration of key patents protecting its flagship products.

    • RXT-200: Core composition-of-matter patents expire in 2030. This opens the door for generic manufacturers to enter the market, which typically leads to significant price erosion and loss of market share. Generic versions of similar kinase inhibitors have seen an average market share loss of 60-80% within two years of generic entry.
    • ALG-110: Patent protection for this immunology drug expires in 2029. Similar to RXT-200, generic and biosimilar competition will emerge, impacting revenue streams.
    • IMN-550: As an antibody-drug conjugate (ADC), it faces potential biosimilar competition, though the complexity of ADCs may create a longer lead time for biosimilar development compared to small molecules.
  2. Intensifying R&D Costs and Clinical Trial Complexity: The cost of drug discovery and development continues to rise. Clinical trials are becoming larger, longer, and more expensive, particularly for oncology and immunology indications.

    • Phase III trials can cost upwards of \$100-200 million. Acrotech’s current pipeline requires substantial ongoing investment.
    • The success rate for drugs entering Phase III trials is approximately 50-60%, indicating significant financial risk associated with pipeline failures.
  3. Emergence of Novel Therapeutic Modalities: While Acrotech is investing in novel modalities like CAR T-cell therapies (CRX-701), the broader field is rapidly advancing with new technologies such as gene editing (CRISPR) and advanced RNA-based therapies, which could offer alternative treatment paradigms.

  4. Dependence on a Limited Product Portfolio: While focused, Acrotech's revenue is currently heavily reliant on a few key products. A significant disruption to any of these, such as unexpected safety concerns or increased competition, could have a disproportionate impact on its financial performance. In fiscal year 2023, RXT-200 and IMN-550 accounted for approximately 69% of total revenue.

  5. Market Access and Reimbursement Challenges: Gaining and maintaining favorable market access and reimbursement from payers (governments and private insurers) is a constant challenge, especially for high-cost specialty drugs. Payers are increasingly scrutinizing drug value and demanding robust real-world evidence of efficacy and cost-effectiveness.

  6. Limited Commercial Infrastructure: Compared to large pharmaceutical giants, Acrotech has a smaller commercial footprint. This can limit its ability to effectively penetrate broad markets, manage multiple product launches simultaneously, and compete for physician attention in crowded therapeutic areas. Its current sales force numbers approximately 500 representatives.

Addressing these threats and weaknesses is crucial for Acrotech’s long-term sustainability and competitive positioning.

What are the Strategic Opportunities for Acrotech?

Acrotech can leverage its existing strengths and address its weaknesses by pursuing several strategic opportunities. These opportunities focus on pipeline expansion, platform utilization, and market access enhancement.

  1. Accelerate Development of Next-Generation Oncology Candidates: Acrotech's oncology pipeline, particularly RXT-310 and CRX-701, represents a significant opportunity.

    • RXT-310: With RXT-200 nearing patent expiry, advancing RXT-310, a next-generation EGFR inhibitor with potential efficacy in resistant mutations, is critical for replacing lost revenue. Successful Phase III trial completion and rapid regulatory approval are paramount.
    • CRX-701: As a CAR T-cell therapy, CRX-701 taps into a rapidly growing segment of oncology treatment. Further investment in clinical validation and manufacturing scale-up for solid tumors, an area where CAR T-cell therapies have historically faced challenges, could yield substantial returns. Acrotech aims to file an IND for a modified version of CRX-701 targeting pancreatic cancer by Q4 2024.
  2. Expand Application of Drug Delivery Platforms: Acrotech’s proprietary delivery technologies are a core asset that can be applied beyond its current therapeutic areas.

    • Neurology: Exploring the NanoSphere™ technology for targeted delivery of therapeutics to the central nervous system (CNS) for conditions like Alzheimer's or Parkinson's disease. CNS drug delivery remains a significant challenge, and Acrotech’s platform could offer a competitive advantage.
    • Rare Diseases: Utilizing LAI formulations to improve treatment adherence and patient convenience for chronic rare diseases where consistent dosing is critical.
  3. Strategic Acquisitions and In-Licensing: To bolster its commercial capabilities and diversify its portfolio, Acrotech could pursue targeted acquisitions or in-licensing opportunities.

    • Commercial Infrastructure: Acquiring a smaller company with an established sales force in a related therapeutic area (e.g., urology or pulmonology) could provide immediate commercial reach without the long lead time of building a sales team from scratch.
    • Complementary Pipeline Assets: In-licensing early-stage or mid-stage assets that align with its oncology or immunology focus could de-risk its R&D portfolio and provide future growth drivers. Acrotech is reportedly evaluating in-licensing opportunities for novel antibody targets in autoimmune diseases.
  4. Geographic Expansion: While Acrotech has a presence in key markets like the U.S. and Europe, expanding its reach into emerging markets could unlock significant growth potential.

    • Asia-Pacific: Establishing commercial partnerships or direct operations in countries like China and Japan, which have growing healthcare expenditures and increasing demand for advanced therapies, could diversify revenue streams. A market entry strategy for South Korea is projected for 2025.
  5. Real-World Evidence (RWE) Generation: Proactively generating and disseminating RWE for its approved products can strengthen market access and reimbursement discussions with payers, demonstrate long-term value, and support lifecycle management strategies. Acrotech initiated a 5-year RWE study for ALG-110 in June 2023.

By strategically pursuing these opportunities, Acrotech can mitigate its competitive threats, capitalize on its strengths, and position itself for sustained growth and value creation.

What are the Implications for R&D Investment and Investment Decisions?

Acrotech’s market dynamics and strategic positioning have direct implications for R&D investment and investment decisions.

For R&D Investment:

  1. Prioritize Pipeline Advancement: Significant investment should continue to flow into advancing RXT-310 and CRX-701 through their respective clinical development phases. The commercial success of these assets is paramount to offsetting patent expirations of current revenue generators.
  2. Validate Delivery Platform Applications: Investment in exploratory studies and early-stage trials to validate the application of NanoSphere™ and LAI technologies in new therapeutic areas (e.g., neurology, rare diseases) is crucial. This diversifies platform risk and expands future market potential.
  3. Invest in Manufacturing Scale-Up: As pipeline candidates progress, substantial investment will be required for manufacturing scale-up, particularly for complex biologics like CRX-701 (CAR T-cell therapy). Ensuring a robust and cost-effective manufacturing process is critical for commercial viability.
  4. Data Generation for Market Access: Allocate resources for generating high-quality real-world evidence (RWE) and health economic outcomes research (HEOR) data. This data is essential for payer negotiations and demonstrating the value proposition of Acrotech's therapies in an increasingly cost-conscious healthcare environment.
  5. Strategic Tech Scouting: Maintain R&D investment in identifying and evaluating emerging therapeutic modalities and technologies that could complement or enhance Acrotech’s existing capabilities. This includes monitoring advancements in gene therapy, mRNA technology, and AI-driven drug discovery.

For Investment Decisions:

  1. Evaluate Pipeline Risk-Reward: Investors must carefully assess the clinical risk and potential commercial reward of Acrotech’s pipeline. The success of RXT-310 and CRX-701 represents a significant binary event for the company’s valuation.
  2. Analyze Patent Cliff Impact: Quantify the projected revenue loss from patent expirations of RXT-200 and ALG-110 and assess Acrotech’s capacity to replace this revenue with new product launches. The company’s ability to manage this transition is a key determinant of future financial performance.
  3. Assess Partnership Value: Evaluate the strategic and financial contributions of Acrotech’s partnerships. The strength and terms of co-development agreements with larger pharmaceutical firms (e.g., Pfizer, Merck) will influence future revenue sharing and commercial success.
  4. Consider Commercial Execution Capability: Investors should assess Acrotech’s ability to successfully launch and commercialize new products, particularly in competitive markets. Its limited commercial infrastructure compared to larger competitors warrants scrutiny.
  5. Scrutinize Balance Sheet and Cash Flow: Given the high R&D expenditures and potential for clinical trial failures, investors must analyze Acrotech’s balance sheet, cash runway, and access to capital. The need for potential future financing rounds or strategic partnerships to fund development must be factored into investment decisions.
  6. Monitor Competitive Landscape: Ongoing monitoring of competitors’ pipeline advancements, regulatory approvals, and market strategies is crucial. Shifts in the competitive landscape can significantly impact Acrotech’s market share and pricing power.

Strategic alignment between R&D investment and robust investment analysis is critical for navigating the complexities of Acrotech’s market position.

Key Takeaways

Acrotech is a specialty pharmaceutical company focused on oncology and immunology, distinguished by proprietary drug delivery technologies and a pipeline of innovative candidates. Its core revenue drivers are RXT-200 and IMN-550. Key strengths include advanced delivery platforms and strategic partnerships, while primary threats are upcoming patent expirations for RXT-200 (2030) and ALG-110 (2029), escalating R&D costs, and generic competition. Strategic opportunities lie in accelerating the development of next-generation oncology drugs like RXT-310, expanding the application of its delivery platforms into new therapeutic areas, and pursuing targeted acquisitions or in-licensing deals. For R&D investment, prioritization should be given to pipeline advancement, delivery platform validation, and market access data generation. Investment decisions require a thorough evaluation of pipeline risk-reward, the impact of patent cliffs, commercial execution capabilities, and the company's financial health.

Frequently Asked Questions

  1. When do Acrotech's key drug patents expire, and what is the projected impact on revenue? Core composition-of-matter patents for RXT-200 expire in 2030, and for ALG-110 in 2029. The market anticipates significant revenue erosion following these expirations due to the introduction of generic and biosimilar competitors, potentially leading to market share losses of 60-80% within two years for comparable small molecule drugs.

  2. What are Acrotech's most promising pipeline candidates, and what stage of development are they in? The most promising pipeline candidates include RXT-310, a next-generation EGFR inhibitor in Phase III trials for NSCLC, and CRX-701, a CAR T-cell therapy targeting solid tumors currently in Phase II development. IMM-220, a small molecule inhibitor for IBD, is also in Phase II.

  3. How does Acrotech differentiate its products from competitors? Acrotech differentiates its products through proprietary drug delivery technologies, such as NanoSphere™ for targeted delivery and Long-Acting Injectables (LAI) for improved patient compliance. Its focused R&D on high-need areas within oncology and immunology also serves as a differentiator.

  4. What is Acrotech's approach to strategic partnerships and collaborations? Acrotech engages in academic collaborations to access early-stage science and co-development agreements with larger pharmaceutical companies, such as Pfizer and Merck, to leverage their expertise and infrastructure for late-stage development and commercialization.

  5. What are the primary financial risks associated with investing in Acrotech? Primary financial risks include the significant impact of upcoming patent expirations on revenue, the high and escalating costs of R&D and clinical trials, the potential failure of pipeline candidates to achieve regulatory approval, and challenges in securing favorable market access and reimbursement for its high-cost specialty drugs.

Citations

[1] Acrotech Annual Report. (2023). Filed with the U.S. Securities and Exchange Commission. [2] FDA Drug Approvals Database. (Ongoing). U.S. Food and Drug Administration. [3] Market Research Report: Oncology Therapeutics. (2023). Global Pharmaceutical Analytics. [4] Patent Filings and Expiry Data. (Ongoing). United States Patent and Trademark Office. [5] Pharmaceutical Industry R&D Cost Analysis. (2022). Pharma Trends Consulting Group.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.