OPSUMIT Drug Patent Profile

When do Opsumit patents expire, 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 one hundred and one patent family members in thirty-five 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 AUROBINDO PHARMA LTD on April 18^th, 2023.

Summary for OPSUMIT

International Patents:	101
US Patents:	5
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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 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	8,268,847*PED				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	9,265,762*PED				Y
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013	AB	RX	Yes	Yes	7,094,781*PED				Y
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013	AB	RX	Yes	Yes	8,367,685*PED				Y
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013	AB	RX	Yes	Yes

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

Lithuania

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
Norway	20081724
Slovenia	1928409
Cyprus	1113395
Brazil	PI0615898
Denmark	2059246
Cyprus	2024033

Supplementary Protection Certificates for OPSUMIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2059246	2490043-3	Sweden		PRODUCT NAME: A COMBINATION OF (A) MACITENTAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) TADALAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1859 20240930
2059246	122024000070	Germany		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 20240927
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
1345920	CA 2014 00012	Denmark		PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131220

Investment Scenario, Market Dynamics, and Financial Trajectory for OPSUMIT

Last updated: February 3, 2026

Summary

This comprehensive analysis evaluates the investment potential, market landscape, and financial outlook for OPSUMIT (macitentan), a medication indicated primarily for pulmonary arterial hypertension (PAH). As a dual endothelin receptor antagonist, OPSUMIT competes in a niche with significant growth prospects driven by increasing PAH prevalence and evolving treatment paradigms. The report covers market size, growth trends, regulatory environment, competitive positioning, revenue projections, and key risks influencing investment decisions.

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Introduction to OPSUMIT: Product Profile and Indications

Parameter	Details
Drug Name	OPSUMIT (macitentan)
Manufacturer	Actelion Pharmaceuticals (a part of Johnson & Johnson)
Regulatory Approval	FDA (2013), EMA (2013), other global markets
Primary Indication	Pulmonary arterial hypertension (PAH)
Mechanism of Action	Dual endothelin receptor antagonist

OPSUMIT received approval based on its efficacy in reducing morbidity and mortality risk by improving exercise capacity and delaying disease progression. Its differentiated profile includes a favorable safety profile and once-daily dosing.

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Market Dynamics: Current Landscape and Drivers

Global Pulmonary Arterial Hypertension Market Overview

Parameter	Estimation / Data
Global Market Size (2022)	USD 2.1 billion
CAGR (2022-2028)	7.5%
Number of PAH Patients (2022)	75,000–80,000 globally
Major Markets	US, EU5, Japan, China

Sources: IQVIA, GlobalData, Bloomberg Intelligence [1][2]

Market Drivers

• Rising Prevalence of PAH: Early diagnosis remains a challenge; however, demographic shifts (aging populations) and better screening increase detected cases.
• Expansion of Indications: Off-label uses and expanded approvals for different PAH classes.
• Treatment Paradigm Shifts: Preference for targeted therapies like OPSUMIT over nonspecific treatments.
• Healthcare Access & Awareness: Improved access in emerging markets.

Market Restraints and Challenges

• Pricing & Reimbursement Constraints: Particularly in Europe and emerging markets.
• Competitive Drugs: Other endothelin receptor antagonists (e.g., bosentan, ambrisentan), prostacyclins, and PDE5 inhibitors.
• Long-term Safety Profile: Surveillance costs and potential adverse events may affect market penetration.

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Competitive Overview: Key Players and Differentiation

Competitor	Product	Mechanism	Market Share (2022)	Remarks
Actelion/J&J	OPSUMIT (macitentan)	Dual endothelin receptor antagonist	~35%	First-to-market advantage, favorable safety profile
Bayer	Bosentan (Tracleer)	Endothelin receptor antagonist	~20%	Older drug, with established safety data
Gilead	Ambrisentan (Letairis)	Endothelin receptor antagonist	~15%	Once-daily dosing, favorable safety profile
Pfizer	Tadalafil (Revatio)	PDE5 inhibitor	~20%	Alternative mechanism, often used in combination therapy

Note: OPSUMIT’s competitive edge derives from its once-daily dosing, safety profile, and robust clinical trial data (SERAPHIN trial).

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Financial Trajectory: Revenue and Growth Projections

Historical Financial Data

Year	Global Sales (USD millions)	Growth Rate	Notes
2017	850	-	Market penetration stabilizing in key regions
2018	1,100	29.4%	Launch in new markets, marketing push
2019	1,350	22.7%	Increased adoption, expanded formulary access
2020	1,600	18.5%	Pandemic impact mitigated in later quarters
2021	1,750	9.4%	Market saturation in developed countries
2022	1,870	6.9%	Slower growth, competitive pressures

Source: Company sales reports, Bloomberg Intelligence[3]

Projected Financial Trajectory (2023-2028)

Year	Estimated Sales (USD millions)	Assumptions	CAGR
2023	2,000	Market expansion, off-label uses, pipeline progress	7.0%
2024	2,140	Increased adoption in Asia and emerging markets	6.7%
2025	2,300	New clinical data supporting broader use	7.0%
2026	2,470	Entry into additional PAH subpopulations	7.0%
2027	2,650	Potential new formulations or indications	7.1%
2028	2,850	Market maturation and steady growth	7.5%

Forecast based on current growth trends, pipeline developments, and market expansion strategies.

Revenue Drivers and Risks

Drivers	Risks
Increased diagnosis and awareness	Patent expiration risks (though J&J maintains exclusivity until 2024)
Market expansion into emerging economies	Competitive erosion by KRAS inhibitors in future or biosimilars
Off-label adoption and combination therapies	Regulatory hurdles in different jurisdictions
Development of next-generation formulations or indications	Changes in reimbursement policies

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Regulatory and Policy Environment

Region	Approval Status	Key Regulations & Policies
United States	Approved since 2013, patent until 2024	CMS reimbursement policies favor high-cost targeted drugs
European Union	Approved since 2013	HTA (Health Technology Assessment) influencing reimbursement
Japan	Approved, market becoming mature	Growing focus on elderly PAH populations
China	Approved, increasing adoption in ERs	Rapid healthcare reforms, dosage, and safety regulations

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Key Investment Considerations

Strengths

• Strong brands and established market presence.
• Clinical trial data (e.g., SERAPHIN) supporting efficacy and safety.
• Favorable dosing convenience.
• Fragmented but growing PAH market.

Weaknesses

• Patent expiry approaching (2024) in major markets.
• Dependence on primarily PAH indications.
• Competition from emerging therapies (e.g., new oral agents).

Opportunities

• Expanding indications (e.g., scleroderma-associated PAH).
• Demographic shifts increasing PAH prevalence.
• Entry into underserved markets (e.g., Africa, Southeast Asia).
• Potential acquisitions or pipeline assets influencing growth.

Threats

• Patent cliffs leading to generic competition.
• Pricing pressures and reimbursement cuts.
• Development of novel drug classes disrupting current therapies.
• Regulatory delays in expanding indications.

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Comparison with Competitors

Parameter	OPSUMIT	Bosentan	Ambrisentan
Market Share (2022)	~35%	~20%	~15%
Approved Indications	PAH, primarily WHO Group 1	PAH, including Eisenmenger’s	PAH, WHO Group 1, in some markets
Dosing Frequency	Once daily	Twice daily	Once daily
Safety Profile	Favorable, fewer hepatic effects	Liver toxicity concerns	Similar to OPSUMIT, safety profile comparable
Patent Status	Valid until 2024	Expired in many markets	Patent expiring soon or expired

Note: OPSUMIT’s differentiation relies on safety, efficacy, and dosing convenience.

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Deep Dive: Future Pipeline and Innovation

• Next-generation endothelin receptor antagonists: Clinical trials focusing on selectivity, reduced adverse events.
• Combination therapies: OPSUMIT combined with PDE5 inhibitors, prostacyclins.
• Biomarker-guided therapy: Improving patient selection and optimizing outcomes.
• Digital health integration: Monitoring and adherence improvements.

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Key Takeaways

• Market Potential: The PAH market, driven by demographic shifts and clinical advancements, presents a steadily growing opportunity, projected to reach USD 3 billion globally by 2028.
• Competitive Position: OPSUMIT holds a strong position due to its clinical data, safety profile, and dosing convenience, though patent expiry in 2024 is a critical milestone.
• Revenue Outlook: Expected to maintain a CAGR of 7-7.5% through 2028, with growth underpinning market expansion and pipeline progress.
• Risks: Patent expiration, competitive threats, pricing dynamics, and regulatory factors pose risks; strategic positioning and pipeline development are key.
• Investment Strategy: Focus on patent management, lifecycle extension, and expanding indications to sustain profitability.

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FAQs

1. What is the primary therapeutic advantage of OPSUMIT over competitors?
   OPSUMIT offers once-daily oral dosing with a favorable safety profile, supported by robust clinical trial data, making it a preferred choice for PAH management.

2. How imminent is patent expiry for OPSUMIT, and what are the implications?
   Patent expiration in major markets (including the US and EU) is scheduled for 2024, raising competition from generics and biosimilars, which could significantly impact revenue.

3. What are the key regulatory challenges for OPSUMIT’s expansion?
   Additional approvals require demonstrating safety and efficacy in broader PAH subsets or other indications, with potential delays due to clinical trial requirements and HTA assessments.

4. What are alternative therapies for PAH, and how might they impact OPSUMIT sales?
   Alternatives include other endothelin receptor antagonists, phosphodiesterase inhibitors, prostacyclins, and combination therapy. The emergence of new classes could erode OPSUMIT’s market share.

5. What pipeline developments could influence OPSUMIT’s future?
   Next-generation endothelin receptor antagonists, combo therapies, and personalized medicine approaches are under clinical evaluation, potentially expanding the market and improving treatment outcomes.

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References

[1] IQVIA, "Global Pulmonary Hypertension Market Data," 2022.

[2] GlobalData, "Pharmaceutical Market Reports," 2022.

[3] Bloomberg Intelligence, "Pharmaceutical Sales and Revenue Analysis," 2022.

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This analysis provides a detailed overview crucial for investors, healthcare strategists, and policy makers evaluating OPSUMIT’s long-term prospects in the rapidly evolving PAH treatment landscape.