OPSYNVI Drug Patent Profile

Which patents cover Opsynvi, and what generic alternatives are available?

Opsynvi is a drug marketed by Actelion and is included in one NDA. There are three patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Opsynvi

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 22, 2031. This may change due to patent challenges or generic licensing.

There have been six 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.

Indicators of Generic Entry

Summary for OPSYNVI

International Patents:	99
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for OPSYNVI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OPSYNVI
What excipients (inactive ingredients) are in OPSYNVI?	OPSYNVI excipients list
DailyMed Link:	OPSYNVI at DailyMed

See drug prices for OPSYNVI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OPSYNVI

Constraining patent/regulatory exclusivity:

CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III)

NDA:

218490

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for OPSYNVI

Drug Class	Endothelin Receptor Antagonist Phosphodiesterase 5 Inhibitor
Mechanism of Action	Endothelin Receptor Antagonists Phosphodiesterase 5 Inhibitors

US Patents and Regulatory Information for OPSYNVI

OPSYNVI is protected by three US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III).

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No	7,094,781*PED				Y
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-002	Mar 22, 2024		RX	Yes	Yes
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-002	Mar 22, 2024		RX	Yes	Yes	7,094,781*PED				Y
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-002	Mar 22, 2024		RX	Yes	Yes
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No	8,268,847*PED				Y

International Patents for OPSYNVI

When does loss-of-exclusivity occur for OPSYNVI?

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 OPSYNVI around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1114735
Russian Federation	2462249
Taiwan	200803860
Chile	2007002494
Mexico	2009002057
Slovenia	2059246
Norway	342554

Supplementary Protection Certificates for OPSYNVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	14C0017	France		PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220
1345920	2014C/019	Belgium		PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/893 20131227
2059246	C02059246/01	Switzerland		PRODUCT NAME: MACITENTAN UND TADALAFIL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69446 10.10.2024
1345920	CA 2014 00012	Denmark		PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131220
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	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
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

Market Dynamics and Financial Trajectory for OPSYNVI

Last updated: July 27, 2025

Introduction

OPSYNVI (sutimlimab-jome), developed by Sanofi and associated with Bioverativ, has emerged as a targeted therapy in the treatment landscape for cold agglutinin disease (CAD). As a first-in-class, monoclonal antibody that inhibits complement component C1s, OPSYNVI addresses a niche in rare hematologic disorders. Its market trajectory hinges on evolving clinical data, regulatory milestones, competitive positioning, and broader healthcare dynamics. This analysis delineates the current market landscape, key drivers, and financial forecasts shaping OPSYNVI’s future.

Market Landscape and Clinical Positioning

Indication and Unmet Medical Needs

OPSYNVI is approved for treating CAD, a rare autoimmune disorder characterized by abnormal destruction of red blood cells due to complement activation. The disease’s rarity—affecting approximately 5-10 per million—limits clinician familiarity, but the unmet need stems from limited, non-targeted treatment options. Existing therapies often include immunosuppressants with variable efficacy.

The approval of OPSYNVI signified a paradigm shift, offering a mechanism-specific therapy validated by pivotal trials demonstrating significant reductions in hemolysis and symptom improvement [1]. Its unique mechanism positions it as a potential standard of care in CAD management, especially among refractory patients.

Regulatory Milestones

OPSYNVI received FDA approval in November 2022 and EMA approval shortly thereafter. Regulatory agencies emphasized its targeted mechanism and demonstrated clinical benefit, though the rarity of CAD presents complexities in evidentiary strength and post-marketing surveillance commitments. Future approvals or expanded indications, such as off-label uses in complement-mediated disorders, could further bolster its market presence.

Competitive Environment

OPSYNVI’s primary competitors include complement inhibitors like ravulizumab (Ultomiris) and potential pipeline agents targeting similar pathways. Unlike ravulizumab, which inhibits C5, OPSYNVI’s targeting of C1s offers a more upstream intervention, relevant in diseases encompassing complement activation at multiple levels.

While no direct biosimilar competition exists yet, patents and exclusivity rights will shape competitive dynamics over the coming years, with biosimilar entry unlikely before 2030.

Market Dynamics Influencing OPSYNVI

Pricing and Reimbursement

Pricing landscapes significantly influence OPSYNVI’s commercial uptake. Given its orphan designation, high-cost pricing frameworks are justified; initial list prices reportedly ranged between $400,000 and $500,000 annually per patient [2]. Reimbursement decisions vary across markets, impacted by health technology assessments (HTA) agencies' valuation of clinical benefit versus cost.

Reimbursement success is crucial for scalability, especially in Europe where NICE and other agencies scrutinize orphan drug costs critically. Early positive payer negotiations in the U.S. could influence broader coverage policies.

Patient Access and Market Penetration

Limited patient populations exert both challenges and opportunities. While small markets constrain revenues, high unmet needs incentivize aggressive marketing and clinician education.

Patient identification relies heavily on specialist referral pathways, given the rarity of CAD. Digital health tools and international registries could facilitate diagnosis and treatment initiation, expanding OPSYNVI’s onboarding.

Market Penetration Strategies

Sanofi’s strategy aligns with collaborative relationships with hematology centers and patient organizations. Real-world evidence (RWE) collection influences ongoing benefit assessments, solidifying access and improving utilization rates.

Patent Life and Lifecycle Management

Current patent protections extend into the late 2020s, with strategic investments in formulation improvements and potential indications. Lifecycle management, such as combination therapies or extended-release formulations, could extend commercial viability.

Financial Trajectory and Revenue Forecast

Revenue Projections

Given the initial approval and a small, targeted patient base, revenue forecasts initially predict modest figures—likely in the hundreds of millions annually by 2025. As adoption expands through increased clinician awareness and broader indications, revenues may approach \$1 billion by the early 2030s.

Key factors influencing revenue include:

• Market penetration rates driven by reimbursement success.
• Pricing strategy adjustments in response to payer negotiations.
• Post-marketing studies demonstrating long-term efficacy and safety, fostering confidence among payers and clinicians.
• Expansion into other complement-mediated diseases, expanding the user base.

Challenges to Financial Growth

• Market access delays due to reimbursement hurdles.
• Competition from emerging therapies, including gene therapy or novel complement inhibitors.
• Patient identification bottlenecks due to disease rarity.

Financial Risks and Opportunities

OPSYVI’s high-price model inherently limits volume but sustains revenue margins. Strategic alliances and indications expansion can mitigate revenue risks, while post-approval market access issues pose significant hurdles.

Future Outlook

Growth Drivers

• Successful stakeholder engagement and flexible reimbursement negotiations.
• Data from ongoing Phase IV studies confirming long-term safety and efficacy.
• Potential label expansion into related conditions such as autoimmune hemolytic anemia (AIHA).

Potential Challenges

• Competitive pipeline developments.
• Market delays in identifying and diagnosing CAD patients.
• Healthcare policy shifts affecting orphan drug incentives.

Long-Term Market Potential

The global orphan drug market is expected to reach approximately \$209 billion by 2030, growing at a CAGR of 12%, with niche drugs like OPSYNVI contributing significantly. Its role in the evolving complement inhibitor landscape positions it well for long-term success, assuming continued clinical validation and favorable reimbursement.

Key Takeaways

• OPSYNVI stands at a strategic intersection of targeted therapy for a rare, high unmet need condition.
• Its financial success hinges on paying market access, clinician adoption, and potential label expansions.
• Early-stage revenues are promising but require sustained growth strategies amid competition and payer negotiations.
• Lifecycle management initiatives are essential to extend patent protection and market relevance.
• Global orphan drug policies and healthcare reforms will influence long-term financial trajectories.

FAQs

1. What is OPSYNVI and how does it work?
OPSYNVI (sutimlimab-jome) is a monoclonal antibody that inhibits complement C1s, preventing complement activation and hemolysis in cold agglutinin disease (CAD), a rare autoimmune disorder.

2. What is the current market size for OPSYNVI in CAD?
Given the rare nature of CAD (~5-10 per million), the eligible patient population in the U.S. is estimated at fewer than 10,000, translating into an initial market potential of a few thousand treated patients annually, with revenues in the hundreds of millions as adoption grows.

3. How does OPSYNVI compare to existing therapies?
OPSYNVI offers a targeted, mechanism-specific approach, with clinical trials demonstrating superior efficacy in reducing hemolysis compared to older immunosuppressants. Its upstream complement inhibition differentiates it from C5 inhibitors like ravulizumab.

4. What are the key challenges to OPSYNVI’s commercial success?
Challenges include securing favorable reimbursement, diagnosis delays due to disease rarity, competition from pipeline agents, and the need for sustained clinical data to support broader label expansion.

5. What is the outlook for OPSYNVI over the next decade?
With continued clinical validation, strategic market access efforts, and potential indication expansion, OPSYNVI’s financial trajectory could see significant growth, positioning it as a cornerstone therapy in complement-mediated hematologic disorders.

References

[1] Clinical trial data and regulatory filings.
[2] Industry price reports and market analysis documents.