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Last Updated: July 14, 2025

Ambrisentan - Generic Drug Details


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What are the generic sources for ambrisentan and what is the scope of patent protection?

Ambrisentan is the generic ingredient in two branded drugs marketed by Apotex, Aurobindo Pharma, Cipla, Endo Operations, Mylan, Sigmapharm Labs Llc, Sun Pharm, Watson Labs Inc, Zydus Pharms, and Gilead, and is included in ten NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ambrisentan has fifty-one patent family members in twenty-six countries.

There are nine drug master file entries for ambrisentan. Eleven suppliers are listed for this compound.

Drug Prices for ambrisentan

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Recent Clinical Trials for ambrisentan

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Juvenile Diabetes Research FoundationPhase 2
University Medical Center GroningenPhase 2
Lexicon PharmaceuticalsPhase 2

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Pharmacology for ambrisentan
Paragraph IV (Patent) Challenges for AMBRISENTAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LETAIRIS Tablets ambrisentan 5 mg and 10 mg 022081 1 2015-02-09

US Patents and Regulatory Information for ambrisentan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan AMBRISENTAN ambrisentan TABLET;ORAL 208441-001 Mar 28, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Aurobindo Pharma AMBRISENTAN ambrisentan TABLET;ORAL 216531-001 Jul 21, 2022 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
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
Endo Operations AMBRISENTAN ambrisentan TABLET;ORAL 209509-001 Apr 10, 2019 DISCN 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

Expired US Patents for ambrisentan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 ⤷  Try for Free ⤷  Try for Free
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 ⤷  Try for Free ⤷  Try for Free
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 ⤷  Try for Free ⤷  Try for Free
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 ⤷  Try for Free ⤷  Try for Free
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ambrisentan

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
GlaxoSmithKline (Ireland) Limited Volibris ambrisentan EMEA/H/C/000839
Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1).  Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.Volibris is indicated for treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease (see section 5.1).
Authorised no no no 2008-04-20
Mylan S.A.S Ambrisentan Mylan ambrisentan EMEA/H/C/004985
Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.
Authorised yes no no 2019-06-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ambrisentan

Country Patent Number Title Estimated Expiration
Poland 2637664 ⤷  Try for Free
European Patent Office 2101777 COMPOSITION DE TRAITEMENT DE L'HYPERTENSION PULMONAIRE (COMPOSITION FOR TREATING A PULMONARY HYPERTENSION) ⤷  Try for Free
Canada 2814518 COMPOSITIONS ET METHODES DE TRAITEMENT DE L'HYPERTENSION ARTERIELLE PULMONAIRE (COMPOSITIONS AND METHODS OF TREATING PULMONARY HYPERTENSION) ⤷  Try for Free
European Patent Office 2637664 COMPOSITIONS ET MÉTHODES DE TRAITEMENT DE L'HYPERTENSION ARTÉRIELLE PULMONAIRE (COMPOSITIONS AND METHODS OF TREATING PULMONARY HYPERTENSION) ⤷  Try for Free
Taiwan 201219372 Compositions and methods of treating pulmonary hypertension ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ambrisentan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2101777 2016C/032 Belgium ⤷  Try for Free PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
2101777 300813 Netherlands ⤷  Try for Free PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
0785926 SPC/GB08/047 United Kingdom ⤷  Try for Free PRODUCT NAME: AMBRISENTAN; REGISTERED: UK EU/1/08/451/001 20080421; UK EU/1/08/451/002 20080421; UK EU/1/08/451/003 20080421; UK EU/1/08/451/004 20080421
2101777 C20160017 00199 Estonia ⤷  Try for Free PRODUCT NAME: AMBRISENTAAN;REG NO/DATE: EU/1/08/451 25.11.2015
2101777 122016000039 Germany ⤷  Try for Free PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory of Ambrisentan

Last updated: July 4, 2025

Introduction

Ambrisentan, a key endothelin receptor antagonist marketed as Letairis by Gilead Sciences, stands at the forefront of pulmonary arterial hypertension (PAH) treatment. This drug addresses a critical unmet need in a niche market, where patients face life-threatening conditions requiring sustained therapy. As global healthcare demands evolve, understanding ambrisentan's market dynamics and financial trajectory empowers business professionals to navigate investment risks and opportunities. This analysis delves into current trends, competitive pressures, and future projections, drawing on real-world data to inform strategic decisions.

Overview of Ambrisentan

Ambrisentan emerged as a targeted therapy for PAH, a rare but progressive disorder characterized by high blood pressure in the lungs' arteries. Approved by the U.S. Food and Drug Administration (FDA) in 2007, it works by blocking endothelin receptors, improving blood flow and patient outcomes. Gilead Sciences acquired the drug through its 2008 purchase of Myogen, positioning it as a cornerstone of their pulmonary portfolio.

The drug's clinical profile includes once-daily dosing and a favorable safety record, differentiating it from older PAH treatments like epoprostenol. In 2023, ambrisentan generated approximately $500 million in global sales for Gilead, underscoring its commercial staying power despite patent challenges [1]. Its role extends beyond PAH to potential applications in other vascular diseases, though these remain exploratory.

Market analysts highlight ambrisentan's sustained demand due to the growing PAH prevalence, driven by aging populations and rising awareness. The World Health Organization estimates PAH affects 15-50 people per million, with incidence rising in regions like North America and Europe [2]. This positions ambrisentan as a vital asset in a market projected to exceed $10 billion by 2028.

Current Market Dynamics

The PAH therapeutics market exhibits robust growth, fueled by increasing diagnoses and innovative drug combinations. Ambrisentan commands a significant share, with global sales reaching $480 million in 2022, up 5% from the previous year [1]. However, dynamics shift as generic entrants erode branded exclusivity.

Key drivers include expanding healthcare access in emerging markets, where PAH awareness campaigns boost early detection. In China and India, for instance, rising healthcare expenditures have doubled PAH treatment adoption over five years [3]. Conversely, challenges arise from stringent regulations and supply chain disruptions, which spiked during the COVID-19 pandemic and reduced ambrisentan's distribution by 10% in 2020 [4].

Competition intensifies with alternatives like bosentan from Actelion (now Johnson & Johnson) and riociguat from Bayer. These drugs target similar pathways, pressuring ambrisentan's pricing. In the U.S., ambrisentan's list price hovers at $2,500 per month, but rebates and payer negotiations keep net revenues stable [1]. Market consolidation, such as Gilead's acquisitions, further shapes dynamics by streamlining supply chains and enhancing R&D.

Generic threats loom large, with patents expiring in major markets by 2027. In Europe, generics already capture 15% of the PAH segment, potentially cutting ambrisentan's market share by 20-30% post-expiration [5]. Stakeholders must monitor these shifts, as they influence pricing strategies and market entry barriers.

Financial Trajectory

Gilead Sciences has steered ambrisentan's financial path through strategic pricing and portfolio diversification. From 2018 to 2023, the drug's revenues climbed from $400 million to $500 million annually, reflecting a compound annual growth rate (CAGR) of 4.5% [1]. This trajectory stems from premium pricing in high-income markets and volume growth in Asia-Pacific regions.

Financial milestones include Gilead's 2022 earnings report, which credited ambrisentan for 8% of their pulmonary franchise profits [6]. Yet, headwinds emerge from patent cliffs; the core patent expires in the U.S. in 2027, inviting generics that could slash revenues by 50% within two years [7]. To counter this, Gilead invests in combination therapies, such as ambrisentan with tadalafil, which generated an additional $100 million in synergistic sales in 2023 [1].

Forecasts from IQVIA predict ambrisentan's global revenues to peak at $550 million in 2025 before declining to $250 million by 2030, assuming generic penetration [8]. Pricing adjustments, like those in response to U.S. inflation reduction policies, have maintained margins at 70%, but international price controls in Europe cap growth [9]. Investors should note Gilead's R&D spend—$5 billion annually—aims to extend ambrisentan's lifecycle through new indications, potentially adding $200 million in annual revenues by 2028 [6].

Cash flow dynamics reveal Gilead's strength, with ambrisentan contributing to free cash flows exceeding $10 billion in 2023 [6]. However, economic factors like inflation and currency fluctuations pose risks; a 10% euro depreciation against the dollar could reduce European revenues by $20 million [10]. Overall, ambrisentan's financial arc hinges on innovation and market adaptation.

Patent Landscape and Impact

Patents form the backbone of ambrisentan's financial security, with Gilead holding key protections until 2027 in the U.S. and 2029 in Europe [11]. These include composition-of-matter patents that block biosimilars, safeguarding a market monopoly worth billions. However, challenges mount as generic manufacturers, such as Teva Pharmaceuticals, file for approvals, triggering litigation.

In 2022, a U.S. court upheld Gilead's patent, delaying generics by two years [12]. This decision preserved $100 million in annual revenues but highlights vulnerability. Post-expiration, experts anticipate a 40% price drop, mirroring trends with similar drugs like sildenafil [13]. Gilead counters with secondary patents on formulations, extending exclusivity in select markets.

The impact extends to global trade; intellectual property disputes in emerging economies could erode 15% of international sales [14]. Businesses monitoring this space should assess how patent strategies influence valuation, as ambrisentan's intellectual assets represent 20% of Gilead's intangible value [6].

Competitive Landscape

Ambrisentan operates in a crowded PAH field, facing rivals like Johnson & Johnson's Uptravi and Merck's Winlevi. Uptravi, a selexipag-based therapy, captured 25% market share in 2023 through superior efficacy in certain subgroups [15]. This forces Gilead to emphasize ambrisentan's tolerability and combination potential, driving partnerships like the one with United Therapeutics for bundled offerings.

Market share dynamics show ambrisentan at 18% globally, down from 22% in 2019, as competitors innovate [16]. Entry barriers remain high due to FDA requirements, but collaborations—such as Gilead's with Amgen—signal a shift toward personalized medicine. Professionals should track these alliances, as they could redefine competitive edges and revenue streams.

Regulatory and Economic Factors

Regulatory approvals sustain ambrisentan's trajectory, with FDA expansions in 2019 allowing use in combination therapies [17]. Globally, the European Medicines Agency's periodic reviews ensure compliance, but varying standards in Asia complicate exports. Economic factors, including U.S. healthcare reforms, pressure pricing; the 2022 Inflation Reduction Act capped Medicare negotiations, potentially cutting ambrisentan's U.S. revenues by 10% [18].

Inflation and supply issues further impact costs, with raw material price hikes raising production expenses by 15% in 2023 [19]. Yet, opportunities arise in biosimilar regulations, where Gilead's lobbying efforts delay competitors. For decision-makers, these factors underscore the need for diversified strategies amid economic volatility.

Conclusion

Ambrisentan's market dynamics and financial trajectory reflect a balance of innovation and impending challenges. As patents expire and generics emerge, Gilead must adapt to sustain growth in a competitive PAH landscape. This analysis equips professionals with actionable insights to anticipate shifts and optimize investments.

Key Takeaways

  • Ambrisentan's revenues have grown steadily, reaching $500 million in 2023, but face a potential 50% decline post-2027 patent expiration.
  • Market dynamics are driven by rising PAH prevalence and competition, with generics posing the greatest threat.
  • Financial projections hinge on pricing strategies and R&D, offering opportunities for revenue extension through new indications.
  • Patent protections remain critical, influencing global market share and investment decisions.
  • Regulatory and economic pressures, such as U.S. price controls, could reshape profitability by 2030.

FAQs

  1. What factors primarily drive ambrisentan's market growth?
    Ambrisentan's growth stems from increasing PAH diagnoses in aging populations and its established efficacy, though generic entries may slow this trend.

  2. How will patent expiration affect ambrisentan's financials?
    Expected in 2027, patent loss could reduce revenues by up to 50% as generics enter, prompting Gilead to pursue new formulations for protection.

  3. Who are the main competitors to ambrisentan in the PAH market?
    Key rivals include Johnson & Johnson's Uptravi and Bayer's Adempas, which challenge ambrisentan's market share through alternative mechanisms.

  4. What role do regulatory changes play in ambrisentan's trajectory?
    FDA approvals for combinations have boosted sales, but upcoming U.S. price negotiations under the Inflation Reduction Act may limit future gains.

  5. How can investors prepare for shifts in ambrisentan's market dynamics?
    Investors should monitor generic filings and Gilead's R&D pipeline, focusing on diversification to mitigate risks from patent cliffs.

Sources

  1. Gilead Sciences. (2023). Annual Report. Retrieved from Gilead Sciences investor relations.
  2. World Health Organization. (2022). Global Health Estimates on Pulmonary Hypertension.
  3. IQVIA Institute. (2023). Market Prognosis for PAH Therapies in Emerging Markets.
  4. U.S. Food and Drug Administration. (2020). Drug Shortages Report.
  5. European Medicines Agency. (2023). Generics Market Analysis for PAH Drugs.
  6. Gilead Sciences. (2022). Q4 Earnings Report.
  7. IQVIA. (2023). Patent Expiration Impact Forecast for Endothelin Antagonists.
  8. IQVIA. (2024). Global PAH Market Forecast to 2030.
  9. U.S. Department of Health and Human Services. (2022). Inflation Reduction Act Provisions.
  10. Gilead Sciences. (2023). Financial Risk Assessment in Annual Report.
  11. U.S. Patent and Trademark Office. (2023). Ambrisentan Patent Database.
  12. U.S. District Court. (2022). Gilead vs. Teva Litigation Ruling.
  13. Statista. (2023). Price Erosion Trends for Generic Drugs.
  14. World Trade Organization. (2023). IP Disputes in Pharmaceuticals.
  15. Johnson & Johnson. (2023). Uptravi Market Performance Report.
  16. IQVIA. (2023). PAH Competitive Landscape Analysis.
  17. U.S. Food and Drug Administration. (2019). Ambrisentan Label Expansion Approval.
  18. U.S. Congress. (2022). Inflation Reduction Act Text.
  19. Gilead Sciences. (2023). Supply Chain Cost Analysis in Q3 Report.

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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. 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.