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Last Updated: June 13, 2025

Endothelin Receptor Antagonist Drug Class List


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Drugs in Drug Class: Endothelin Receptor Antagonist

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sigmapharm Labs Llc AMBRISENTAN ambrisentan TABLET;ORAL 208354-002 Apr 10, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Cipla AMBRISENTAN ambrisentan TABLET;ORAL 210715-002 Apr 26, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Apotex AMBRISENTAN ambrisentan TABLET;ORAL 210701-002 May 19, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Zydus Pharms AMBRISENTAN ambrisentan TABLET;ORAL 210058-001 Mar 28, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Endothelin Receptor Antagonist Market Analysis and Financial Projection

The Endothelin Receptor Antagonist (ERA) drug class is experiencing transformative growth driven by clinical demand and strategic innovation, while navigating complex patent dynamics. Below is a detailed analysis of the market and intellectual property landscape:


Market Dynamics

Growth Drivers

  • Rising Disease Prevalence: ERAs are critical for treating pulmonary arterial hypertension (PAH), cardiovascular diseases, and chronic kidney conditions. Over 103 million U.S. adults have hypertension, while PAH affects ~15–50 per million globally, driving demand[1][11].
  • Strategic Industry Collaborations: Mergers, acquisitions, and partnerships are accelerating R&D. For example, Viatris Inc. (formed via Mylan-Pfizer Upjohn merger) expanded its PAH portfolio with drugs like Revatio[1].
  • Generic Drug Expansion: Post-patent expirations (e.g., Actelion’s bosentan in 2015) have enabled affordable generics, particularly in Asia-Pacific, where economic growth and healthcare investment are boosting access[1][7][8].

Opportunities

  • Orphan Drug Incentives: Government support for rare disease therapies, such as the FDA’s orphan drug designation for GMA301 (a monoclonal antibody for PAH), incentivizes innovation[12][14].
  • Pipeline Advancements: Over 15 ERA candidates are in development, including AstraZeneca’s Zibotentan (Phase III for chronic kidney disease) and Biocity Biopharmaceutics’ SC0062 (Phase II for diabetic nephropathy)[3][12].

Challenges

  • High Treatment Costs: ERA therapies remain expensive, limiting access in low-income regions[1].
  • Patent Cliffs: Key patents, such as Actelion’s bosentan (expiring May 2026 and December 2027), risk revenue loss for originators while benefiting generics[4][7].

Patent Landscape

Key Patents and Innovations

  • Novel Compounds: Actelion’s patent (7,094,781) covers pyrimidine-sulfamide ERAs used in PAH treatment[6]. Idorsia recently filed patents for crystalline forms of ERA compounds to enhance stability and efficacy[14].
  • Geographic Strategies: Companies prioritize filings in North America, Europe, and Asia-Pacific, with China emerging as a hub for ERA R&D[2][13].

Competitive IP Strategies

  • White Space Identification: Patent landscape analyses help firms avoid crowded areas (e.g., small molecules) and target underdeveloped niches like monoclonal antibodies (e.g., GMA301)[10][13].
  • Litigation Avoidance: Actelion’s settlements with generics post-bosentan patent expiry exemplify strategies to mitigate legal risks while retaining market share[7].

Regional Insights

  • North America: Dominates with ~40% market share due to advanced healthcare infrastructure and high PAH diagnosis rates[1][8].
  • Asia-Pacific: Fastest-growing region (6.5% CAGR) driven by affordable generics, improving healthcare access, and rising economic investment[1][11].

Competitive Pipeline

Drug Company Stage Indication
Zibotentan AstraZeneca Phase III Chronic Kidney Disease
SC0062 Biocity Biopharmaceutics Phase II Diabetic Nephropathy
GMA301 Gmax Biopharm Phase I Pulmonary Arterial Hypertension

Strategic Outlook

The ERA market will hinge on balancing innovation with affordability. While pipeline drugs and orphan designations promise growth, patent expirations and generic competition will reshape revenue streams. Companies leveraging patent analytics to identify white spaces (e.g., combination therapies, novel formulations) are best positioned to lead[10][13].

Highlight: “Patent landscape analysis is critical for navigating crowded therapeutic areas and prioritizing R&D investments.” [10]

Regional diversification and partnerships with generics manufacturers will be key to capturing growth in emerging markets like Asia-Pacific, where healthcare access is rapidly improving[1][8].

References

  1. https://www.databridgemarketresearch.com/reports/global-endothelin-antagonists-therapeutics-market
  2. https://synapse.patsnap.com/blog/what-are-endothelin-receptor-antagonists-and-how-do-you-quickly-get-the-latest-development-progress
  3. https://www.researchandmarkets.com/report/global-endothelin-receptor-antagonist-market
  4. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209279Orig1s000OtherR.pdf
  5. https://marketresearchpulse.com/report/129762/endothelin-receptor-antagonist-market
  6. https://www.drugpatentwatch.com/p/patent/7094781
  7. https://casetext.com/case/mayor-v-actelion-pharm-ltd
  8. https://www.marketresearchintellect.com/product/endothelin-antagonists-therapeutics-market/
  9. https://www.marketresearchintellect.com/product/global-endothelin-receptor-antagonist-market/
  10. https://pstc.org/wp-content/uploads/2021/05/Rappaport_Matthew.pdf
  11. https://www.verifiedmarketreports.com/product/endothelin-antagonists-therapeutics-market/
  12. https://www.globenewswire.com/news-release/2025/03/04/3036253/28124/en/2025-Endothelin-Receptor-Antagonist-Pipeline-Insights-for-10-Companies-and-15-Pipeline-Drugs-Including-Zibotentan-AstraZeneca-SC0062-Biocity-Biopharmaceutics-and-GMA301-Gmax-Biopha.html
  13. https://patentpc.com/blog/how-to-conduct-an-effective-patent-landscape-analysis-to-inform-filing-decisions/
  14. https://www.pharmaceutical-technology.com/data-insights/idorsia-pharmaceutical-files-patent-for-novel-crystalline-forms-of-endothelin-receptor-antagonist/
Last updated: 2025-04-03

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