opsumit Drug Patent Profile

When do Opsumit patents expire, and what generic alternatives are available?

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^® Litigation and Generic Entry Outlook for Opsumit

A generic version of opsumit was approved as macitentan by ALEMBIC on August 18^th, 2025.

Summary for opsumit

International Patents:	99
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	17
Patent Applications:	984
Drug Prices:	Drug price information for opsumit
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for opsumit
What excipients (inactive ingredients) are in opsumit?	opsumit excipients list
DailyMed Link:	opsumit at DailyMed

See drug prices for opsumit

Recent Clinical Trials for opsumit

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

Sponsor	Phase
Janssen, LP	Phase 4
American Heart Association	Phase 4
Janssen Pharmaceutical K.K.	Phase 3

See all opsumit clinical trials

Pharmacology for opsumit

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Endothelin Receptor Antagonists

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 two FDA Regulatory Exclusivities.

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	AB	RX	Yes	Yes					Y
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013	AB	RX	Yes	Yes
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013	AB	RX	Yes	Yes					Y
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013	AB	RX	Yes	Yes					Y
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013	AB	RX	Yes	Yes					Y
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013	AB	RX	Yes	Yes

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/002697Opsumit, 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

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

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Malaysia

Mexico

Morocco

Netherlands

New Zealand

Norway

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Taiwan

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
Austria	323079
Taiwan	I388556
Taiwan	I323661
Brazil	PI0615898
Croatia	P20120957
Hungary	S2400046

Supplementary Protection Certificates for opsumit

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2059246	LUC00371	Luxembourg		PRODUCT NAME: A COMBINATION OF (A) MACITENTAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) TADALAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/24/1859 20240930
2059246	45/2024	Austria		PRODUCT NAME: KOMBINATION AUS (A) MACITENTAN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON UND (B) TADALAFIL ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON; REGISTRATION NO/DATE: EU/1/24/1859 (MITTEILUNG) 20240930
1345920	502	Finland
1345920	C300672	Netherlands		PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920	14C0017	France		PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220
2059246	CA 2024 00050	Denmark		PRODUCT NAME: KOMBINATION AF (A) MACITENTAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG (B) TADALAFIL ELLER ET FAR-MACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/24/1859 20240930

Market Dynamics and Financial Trajectory for OPSUMIT

Last updated: July 27, 2025

Introduction

OPSUMIT (macitentan) is a novel endothelium receptor antagonist approved by the FDA and EMA for the treatment of pulmonary arterial hypertension (PAH). As a significant entrant in the PAH therapeutics market, understanding its market dynamics and financial trajectory is vital for stakeholders, including investors, pharmaceutical companies, and healthcare providers. This analysis evaluates the product’s current market position, competitive landscape, regulatory factors, commercialization strategies, and financial forecasts.

Market Overview and Key Drivers

The PAH market, valued at approximately $4.2 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 7-8% through 2030, driven by increasing prevalence, earlier diagnosis, and emerging treatment options [1]. OPSUMIT, marketed by Bayer, entered a competitive landscape comprising drugs such as bosentan (Tracleer), ambrisentan (Letairis), and selexipag (Uptravi).

The primary market drivers include:

• Rising Prevalence: PAH affects roughly 15-50 affected individuals per million worldwide, with an increasing incidence linked to conditions like connective tissue diseases and congenital heart defects [2].
• Improved Diagnosis: Advances in imaging and screening facilitate earlier detection, expanding the eligible population for OPSUMIT.
• Therapeutic Advances: The drug’s efficacy in improving exercise capacity and delaying clinical worsening underpins its adoption.

Market Dynamics

Regulatory Landscape and Approvals

OPSUMIT’s FDA approval in 2013 and subsequent EMA approval positioned it as a first-line treatment option. Regulatory barriers, including safety profiles, necessitate rigorous post-marketing surveillance, impacting sales trajectories but reinforcing credibility. Ongoing expansion into regional markets depends on local approvals, which can delay revenue streams.

Competitive Environment

OPSUMIT faces competition from:

• Endothelin receptor antagonists (ERAs): Bosentan, ambrisentan, and macitentan’s other formulations.
• Prostacyclin Pathway Agents: Epoprostenol, treprostinil, with complex administration routes.
• Selective PDE-5 Inhibitors: Sildenafil (Revatio) and tadalafil (Adcirca).
• Emerging Agents: Selexipag (Uptravi), a prostacyclin receptor agonist.

OPSUMIT's advantages include once-daily dosing, favorable safety profile, and demonstrated improvement in clinical endpoints, fostering its position in treatment algorithms.

Pricing Strategy and Reimbursement

OPSUMIT’s pricing in the U.S. ranges approximately between $3,200-$4,800 per month, with variations based on dosage and region [3]. Reimbursement policies favor early adoption, especially in developed markets with high healthcare spending. Cost-effectiveness analyses favor OPSUMIT due to its efficacy and tolerability, supporting favorable formulary placements.

Financial Trajectory

Sales Performance and Revenue

Since its launch, OPSUMIT has exhibited steady growth, with global sales reaching approximately $1.4 billion in 2022. Market penetration is particularly high in North America and Europe, with emerging markets contributing increasingly.

Growth Catalysts

• Expanding Indications: Ongoing clinical trials explore use in associated conditions like systemic sclerosis-associated PAH, potentially broadening its addressable market.
• Regional Expansion: Regulatory approvals in Asia-Pacific and Latin America are expected to open new revenue streams.
• Pipeline Products and Biosimilars: Bayer’s emphasis on clinical development could influence future sales trajectories.

Risks and Challenges

• Pricing pressures and increasing healthcare cost containment measures pose risks.
• Generic Competition: Patent expirations could introduce biosimilars or generics, impacting pricing and market share.
• Clinical Limitations: Safety concerns like anemia, edema, and contraindications necessitate careful patient selection.

Market Outlook and Strategic Considerations

The outlook for OPSUMIT remains positive, driven by a growing patient base, clinical validation, and strategic geographic expansion. Key considerations include:

• Differentiation Strategies: Emphasizing efficacy and safety advantages over competitors.
• Pricing Strategies: Balancing profitability with market access.
• Partnerships and Collaborations: Engaging with regional distributors and clinical research entities to expand reach.

Conclusion

OPSUMIT’s market dynamics are shaped by regulatory developments, competitive pressures, and increasing global demand for effective PAH therapies. Financial trajectories forecast sustained growth with potential acceleration via regional expansion, pipeline development, and new indications. Strategic positioning—focused on clinical efficacy, reimbursement strategies, and geographic penetration—will determine its long-term market share and revenue streams.

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Key Takeaways

• OPSUMIT commands a significant share of the PAH market, positioned as a potent, once-daily oral therapy.
• The global PAH market's CAGR of approximately 7-8% presents and sustains growth opportunities for OPSUMIT.
• Competitive landscape challenges can be mitigated through emphasizing its safety profile and clinical benefits.
• Regulatory dynamics and pricing strategies will heavily influence sales trajectories, especially in emerging markets.
• Future growth hinges on geographic expansion, new indications, and managing patent and biosimilar uncertainties.

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FAQs

1. How does OPSUMIT compare to other endothelin receptor antagonists?
OPSUMIT offers once-daily dosing with a favorable safety profile and demonstrated efficacy in improving exercise capacity, potentially providing a clinical advantage over some competitors with less convenient dosing regimens.

2. What are the main constraints affecting OPSUMIT’s market penetration?
Regulatory delays in emerging markets, patent expirations leading to biosimilar threats, and cost containment measures are primary constraints impacting its growth.

3. Are there emerging indications that could expand OPSUMIT's market?
Yes. Ongoing clinical trials are assessing its use in connective tissue disease-associated PAH and other related conditions, which could broaden its therapeutic scope.

4. What regional expansion opportunities exist for OPSUMIT?
Regions like Asia-Pacific and Latin America represent significant growth potentials due to increasing PAH prevalence and improving healthcare infrastructure.

5. How might future patent expirations affect OPSUMIT’s financial performance?
Patent expirations could lead to biosimilar competition, potentially reducing prices and markets share, though timely pipeline development and indication expansion can offset these risks.

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References

[1] MarketResearch.com, "Pulmonary Arterial Hypertension Market Forecast," 2022
[2] Galiè N, et al. "Guidelines for diagnosis and treatment of pulmonary hypertension," Eur Respir J, 2015
[3] GoodRx, "OPSUMIT pricing and cost analysis," 2023