OPSUMIT Drug Patent Profile

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

Summary for OPSUMIT

International Patents:	99
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	17
Patent Applications:	686
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 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
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes			Y
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes			Y
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes			Y
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes			Y	Y

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

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

Supplementary Protection Certificates for OPSUMIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	122014000056	Germany		PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
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	92381	Luxembourg		PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT)
1345920	2014C/019	Belgium		PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/893 20131227
1345920	2014/018	Ireland		PRODUCT NAME: MACITENTAN, THE STEREOISOMERS AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/893 20131220
1345920	300672	Netherlands		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		PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220

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.