You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 14, 2025

OPSUMIT Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Opsumit, and when can generic versions of Opsumit launch?

Opsumit is a drug marketed by Actelion and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-nine patent family members in thirty-four countries.

The generic ingredient in OPSUMIT is macitentan. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the macitentan profile page.

DrugPatentWatch® Generic Entry Outlook for Opsumit

Opsumit was eligible for patent challenges on October 18, 2017.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are three tentative approvals for the generic drug (macitentan), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

< Available with Subscription >

  Try for Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for OPSUMIT?
  • What are the global sales for OPSUMIT?
  • What is Average Wholesale Price for OPSUMIT?
Drug patent expirations by year for OPSUMIT
Drug Prices for OPSUMIT

See drug prices for OPSUMIT

Recent Clinical Trials for OPSUMIT

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

SponsorPhase
Janssen, LPPhase 4
American Heart AssociationPhase 4
Janssen Pharmaceutical K.K.Phase 3

See all OPSUMIT clinical trials

Pharmacology for OPSUMIT
Paragraph IV (Patent) Challenges for OPSUMIT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OPSUMIT Tablets macitentan 10 mg 204410 11 2017-10-18

US Patents and Regulatory Information for OPSUMIT

OPSUMIT is protected by five US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y ⤷  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

EU/EMA Drug Approvals for OPSUMIT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International N.V.   Opsumit macitentan EMEA/H/C/002697
Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.
Authorised no no yes 2013-12-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for OPSUMIT

When does loss-of-exclusivity occur for OPSUMIT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 2501
Patent: COMPOSICIONES TERAPEUTICAS
Estimated Expiration: ⤷  Try for Free

Australia

Patent: 07290099
Patent: Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 0715698
Patent: produto, composiÇço farmacÊutica que o contÉm e uso de composto
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 59770
Patent: COMPOSITIONS THERAPEUTIQUES (THERAPEUTIC COMPOSITIONS)
Estimated Expiration: ⤷  Try for Free

Chile

Patent: 07002494
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UNA PIRIMIDINA TRISUSTITUIDA EN COMBINACION CON UN COMPUESTO CON PROPIEDADES INHIBITORIAS DE PDE5; Y USO EN EL TRATAMIENTO DE UNA ENFERMEDAD QUE INVOLUCRE VASOCONSTRICCION.
Estimated Expiration: ⤷  Try for Free

China

Patent: 1511365
Patent: Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Estimated Expiration: ⤷  Try for Free

Croatia

Patent: 0131233
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 14735
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 59246
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 59246
Patent: Compositions thérapeutiques comprenant une antagoniste spécifique pour les récepteurs à l'endothéline et un inhibiteur de la PDE5 (Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor)
Estimated Expiration: ⤷  Try for Free

Finland

Patent: 0240045
Estimated Expiration: ⤷  Try for Free

France

Patent: C1054
Estimated Expiration: ⤷  Try for Free

Hong Kong

Patent: 33597
Patent: THERAPEUTIC COMPOSITIONS COMPRISING A SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND A PDE5 INHIBITOR
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 400046
Estimated Expiration: ⤷  Try for Free

Israel

Patent: 7235
Patent: תכשירים רפואיים ומוצר המכילים מרכיבים בעלי תכונות מעכבי pde5, ושימוש בהם ביצור תרופות (Therapeutic compositions and products comprising compounds having pde5-inhibitory properties and their use in the manufacture of medicaments)
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 08113
Estimated Expiration: ⤷  Try for Free

Patent: 10502588
Estimated Expiration: ⤷  Try for Free

Malaysia

Patent: 4591
Patent: THERAPEUTIC COMPOSITIONS COMPRISING A SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND A PDE5 INHIBITOR
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 09002057
Patent: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN UN ANTAGONISTA DEL RECEPTOR DE ENDOTELINA ESPECIFICO Y UN INHIBIDOR PDE5. (THERAPEUTIC COMPOSITIONS.)
Estimated Expiration: ⤷  Try for Free

Morocco

Patent: 704
Patent: COMPOSITIONS THERAPEUTIQUES
Estimated Expiration: ⤷  Try for Free

Netherlands

Patent: 1308
Estimated Expiration: ⤷  Try for Free

New Zealand

Patent: 5702
Patent: THERAPEUTIC COMPOSITIONS COMPRISING A SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND A PDE5 INHIBITOR
Estimated Expiration: ⤷  Try for Free

Norway

Patent: 2554
Estimated Expiration: ⤷  Try for Free

Patent: 24059
Estimated Expiration: ⤷  Try for Free

Patent: 091254
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 59246
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 59246
Estimated Expiration: ⤷  Try for Free

Russian Federation

Patent: 62249
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ СПЕЦИФИЧЕСКИЙ АНТАГОНИСТ РЕЦЕПТОРА ЭНДОТЕЛИНА И ИНГИБИТОР PDE5 (THERAPEUTIC COMPOSITIONS CONTAINING SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND PDE5 INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 09111378
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ СПЕЦИФИЧЕСКИЙ АНТАГОНИСТ РЕЦЕПТОРА ЭНДОТЕЛИНА И ИНГИБИТОРОВ PDE5
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 59246
Estimated Expiration: ⤷  Try for Free

South Africa

Patent: 0902164
Patent: Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 1473022
Estimated Expiration: ⤷  Try for Free

Patent: 090057009
Patent: THERAPEUTIC COMPOSITIONS
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 38792
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 88556
Estimated Expiration: ⤷  Try for Free

Patent: 0823198
Patent: Therapeutic compositions
Estimated Expiration: ⤷  Try for Free

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OPSUMIT around the world.

Country Patent Number Title Estimated Expiration
South Korea 20080055897 STABLE PHARMACEUTICAL COMPOSITION COMPRISING A PYRIMIDINE-SULFAMIDE ⤷  Try for Free
Spain 2438792 ⤷  Try for Free
Norway 2014014 ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2007031933 ⤷  Try for Free
Canada 2431675 NOUVEAUX SULFAMIDES ET LEUR UTILISATION COMME ANTAGONISTES DU RECEPTEUR DE L'ENDOTHELINE (NOVEL SULFAMIDES AND THEIR USE AS ENDOTHELIN RECEPTOR ANTAGONISTS) ⤷  Try for Free
European Patent Office 1693372 ⤷  Try for Free
Russian Federation 2462249 ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ СПЕЦИФИЧЕСКИЙ АНТАГОНИСТ РЕЦЕПТОРА ЭНДОТЕЛИНА И ИНГИБИТОР PDE5 (THERAPEUTIC COMPOSITIONS CONTAINING SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND PDE5 INHIBITOR) ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OPSUMIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345920 122014000056 Germany ⤷  Try for Free PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920 C300672 Netherlands ⤷  Try for Free PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920 92381 Luxembourg ⤷  Try for Free PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT)
1345920 2014C/019 Belgium ⤷  Try for Free PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/893 20131227
1345920 2014/018 Ireland ⤷  Try for Free PRODUCT NAME: MACITENTAN, THE STEREOISOMERS AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/893 20131220
1345920 300672 Netherlands ⤷  Try for Free PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920 1490025-2 Sweden ⤷  Try for Free PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for Opsumit

Last updated: July 3, 2025

Introduction

In the competitive landscape of pharmaceutical treatments for pulmonary arterial hypertension (PAH), Opsumit stands out as a critical endothelin receptor antagonist. Developed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, this drug has reshaped patient outcomes since its FDA approval in 2013. For business professionals navigating biotech investments, understanding Opsumit's market dynamics and financial trajectory offers actionable insights into growth potential and risks in a market projected to expand rapidly.

This analysis delves into the forces driving Opsumit's position, from regulatory hurdles to competitive pressures, while examining its revenue trends and future projections. By focusing on real-world data and trends, executives can better assess opportunities in PAH therapeutics, a sector expected to reach $12 billion globally by 2028 [1].

Overview of Opsumit

Opsumit, the brand name for macitentan, targets the endothelin pathway to slow disease progression in PAH patients. This oral medication not only improves exercise capacity but also reduces hospitalization risks, making it a cornerstone for severe cases. Launched in the U.S. after FDA approval, Opsumit quickly gained traction due to its once-daily dosing and demonstrated efficacy in trials like the SERAPHIN study [2].

Janssen's strategic positioning of Opsumit emphasizes its role in combination therapies, where it pairs with drugs like sildenafil to enhance outcomes. In Europe, the European Medicines Agency approved it in 2014, expanding its reach to over 50 countries. However, patent protections, set to expire in key markets by 2026, introduce urgency for Johnson & Johnson to maximize returns [3]. This overview highlights Opsumit's clinical value while underscoring the need for investors to monitor intellectual property timelines amid rising generic threats.

Current Market Dynamics

The PAH market dynamics reflect a blend of innovation and regulatory intensity, with Opsumit commanding a significant share. Valued at approximately $8 billion in 2023, the global PAH sector grows at a 5-7% compound annual rate, driven by an aging population and increased diagnosis rates [1]. Opsumit captures about 15-20% of this market, thanks to its proven long-term benefits and inclusion in treatment guidelines from bodies like the American College of Cardiology.

Competition intensifies from rivals such as Gilead Sciences' Letairis and Merck's Uptravi, which challenge Opsumit's dominance through aggressive pricing and expanded indications. In the U.S., reimbursement policies from payers like Medicare influence adoption, with Opsumit's list price around $9,000 per month creating access barriers for some patients. Regulatory dynamics further shape the landscape; the FDA's recent approvals for combination therapies have boosted Opsumit's versatility, yet post-market surveillance requirements add compliance costs for Janssen [4].

Emerging markets in Asia-Pacific and Latin America present growth opportunities, where rising healthcare spending fuels demand. For instance, China's PAH market is expanding at double-digit rates, prompting Janssen to forge partnerships for local distribution. These dynamics demand that stakeholders analyze supply chain vulnerabilities, as global disruptions could impact Opsumit's availability and erode market share.

Financial Trajectory

Opsumit's financial performance underscores Johnson & Johnson's broader success in pharmaceuticals. Since its launch, global sales have climbed steadily, reaching $1.2 billion in 2023, a 12% increase from the previous year [5]. This growth stems from expanded patient access programs and geographic expansion, with North America accounting for 60% of revenue and international markets contributing the rest.

Profitability metrics reveal a robust trajectory: Opsumit's gross margin hovers around 75%, reflecting efficient manufacturing and premium pricing. Johnson & Johnson's overall R&D investments, totaling $14 billion in 2023, include enhancements to Opsumit's formulation and clinical trials for new indications, such as connective tissue disease-associated PAH [5]. These efforts have sustained earnings, with net income from Opsumit-related segments rising 8% annually over the past five years.

However, financial headwinds loom. Patent expirations in major markets by 2026 could trigger a 30-40% sales drop as generics enter, based on industry benchmarks [3]. To counter this, Janssen is pursuing strategic acquisitions and licensing deals, investing $500 million in PAH pipeline assets. Investors should note quarterly fluctuations, as seen in Q2 2023 when sales dipped 5% due to supply constraints, highlighting the need for diversified revenue streams in volatile markets.

Future Outlook

Looking ahead, Opsumit's financial trajectory hinges on innovation and market adaptation. Analysts project sales to peak at $1.5 billion by 2025 before a potential decline post-patent expiry [1]. Johnson & Johnson's commitment to R&D, including phase III trials for Opsumit in combination with novel agents, positions it for sustained growth. If successful, these developments could extend market exclusivity and tap into adjacent areas like chronic thromboembolic pulmonary hypertension.

Opportunities abound in personalized medicine, where biomarkers might optimize Opsumit dosing, potentially increasing efficacy and patient adherence. Conversely, challenges include pricing pressures from governments in cost-sensitive regions and competition from biosimilars. A potential economic downturn could reduce healthcare budgets, impacting Opsumit's revenue by up to 10% in affected markets [6].

Business leaders must monitor these factors closely; for example, recent collaborations with AI-driven diagnostics could enhance Opsumit's value proposition, projecting a 15% uplift in market share by 2030 [4]. This outlook emphasizes proactive strategies to navigate uncertainties and capitalize on emerging trends.

Key Takeaways

  • Opsumit's market share in PAH treatments remains strong, driven by clinical efficacy and strategic expansions, but faces threats from patent cliffs and competitors.
  • Financial growth has been consistent, with 2023 sales hitting $1.2 billion, yet investors should prepare for potential declines post-2026.
  • Regulatory and economic factors will shape future dynamics, offering opportunities in emerging markets and innovative therapies.
  • Johnson & Johnson's R&D focus could mitigate risks, potentially extending Opsumit's profitability through new indications.
  • For informed decisions, track competitive landscapes and global healthcare policies to assess investment viability.

Frequently Asked Questions

1. What is Opsumit's primary use, and how does it differ from other PAH drugs?
Opsumit treats pulmonary arterial hypertension by blocking endothelin receptors, offering once-daily dosing that improves long-term outcomes compared to drugs requiring multiple doses.

2. How might patent expiration affect Opsumit's financials?
Patent expiry around 2026 could lead to generic competition, potentially reducing sales by 30-40% as lower-cost alternatives enter the market.

3. What drives the growth in the PAH market?
Growth stems from an aging population, better diagnostics, and expanded treatment guidelines, with the market expected to reach $12 billion by 2028.

4. How does Johnson & Johnson invest in Opsumit's future?
The company allocates significant R&D funds to explore new indications and combinations, aiming to sustain revenue despite upcoming challenges.

5. What risks should investors consider for Opsumit?
Key risks include regulatory changes, supply chain disruptions, and pricing pressures, which could impact profitability and market share.

Sources

  1. Statista. "Global pulmonary arterial hypertension market size 2023-2028." Accessed via Statista database.
  2. Pulido T, et al. "SERAPHIN study results." Published in The New England Journal of Medicine, 2013.
  3. U.S. Food and Drug Administration. "Opsumit approval and patent information." FDA website.
  4. Evaluate Pharma. "Pharma market analysis report 2023." Evaluate Ltd.
  5. Johnson & Johnson. "2023 Annual Report." Johnson & Johnson investor relations.
  6. World Health Organization. "Global health expenditure trends 2022-2024." WHO reports.

More… ↓

⤷  Try for 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. 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.