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-four patent family members in thirty-two 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 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.

Indicators of Generic Entry

Summary for OPSYNVI

International Patents:	94
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 two 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			Y
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-002	Mar 22, 2024		RX	Yes	Yes			Y
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No

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

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

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
Morocco	30704	COMPOSITIONS THERAPEUTIQUES
Denmark	2059246
Norway	20032699

Supplementary Protection Certificates for OPSYNVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	SPC/GB14/018	United Kingdom		PRODUCT NAME: MACITENTAN, WHICH IS N-(5-(4-BROMOPHENYL)-6-(2((5-BROMOPYRIMIDIN-2-YL)OXY)ETHOXY)PYRIMIDIN-4-YL)-N'-PROPYLSULFURIC DIAMIDE; REGISTERED: UK EU/1/13/893 20131220
1345920	14C0017	France		PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220
1345920	132014902244514	Italy		PRODUCT NAME: MACITENTAN(OPSUMIT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/893/001-002, 20131220

OPSYNVI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OPSYNVI

Introduction to OPSYNVI

OPSYNVI, a groundbreaking medication combining macitentan and tadalafil, has recently been approved by the U.S. FDA for the treatment of Pulmonary Arterial Hypertension (PAH). This approval marks a significant milestone in the management of this rare and progressive disease.

Clinical Significance and Efficacy

OPSYNVI is the first and only once-daily single-tablet combination therapy for PAH patients. The FDA's approval is based on the results from the pivotal Phase 3 A DUE study, which demonstrated that OPSYNVI achieved a greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks compared to tadalafil or macitentan monotherapy[1][4].

Market Positioning

With the approval of OPSYNVI, Johnson & Johnson now offers a comprehensive PAH portfolio that addresses all three foundational and guideline-recommended pathways for this disease: nitric oxide, endothelin, and prostacyclin. This positioning strengthens Johnson & Johnson's leadership in the PAH treatment market and aligns with clinical guideline recommendations for early use of combination therapy[1][4].

Safety and Regulatory Considerations

OPSYNVI comes with a Boxed Warning due to the risk of embryo-fetal toxicity, necessitating female patients to enroll in the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS) program. This regulatory requirement is crucial for ensuring patient safety while managing the risks associated with the medication[1][4].

Market Impact

The introduction of OPSYNVI is expected to significantly impact the PAH treatment market. Here are a few key points:

Patient Compliance

• The once-daily dosing regimen of OPSYNVI can improve patient compliance, as it simplifies the treatment process compared to multiple daily doses of separate medications[1][4].

Clinical Outcomes

• The combination therapy has shown superior pulmonary hemodynamic improvement, which can lead to better clinical outcomes for PAH patients. This could result in increased market share as healthcare providers and patients opt for the more effective treatment option[1][4].

Competitive Landscape

• Johnson & Johnson's comprehensive PAH portfolio, now including OPSYNVI, positions the company as a leader in this therapeutic area. This could influence market dynamics by attracting more patients and healthcare providers to Johnson & Johnson's treatments[1][4].

Financial Trajectory

Revenue Potential

• The approval of OPSYNVI is expected to contribute to Johnson & Johnson's revenue growth, particularly within the Innovative Medicine segment. Given the strong performance of Johnson & Johnson's key brands and recently launched products, OPSYNVI is likely to drive additional sales growth[3][5].

Operational Sales Growth

• In 2023, Johnson & Johnson reported above-market operational sales growth of 7.2% in the Innovative Medicine segment, excluding COVID-19 vaccine sales. The introduction of OPSYNVI is anticipated to further boost this growth, aligning with the company's overall strategy of delivering innovative medicines[3][5].

R&D Investments

• Johnson & Johnson's significant investment in R&D, amounting to $15.1 billion in 2023 (almost 18% of sales), underscores the company's commitment to innovation. The success of OPSYNVI and other pipeline products is a direct result of these investments, which are expected to yield long-term financial benefits[5].

Risks and Challenges

Regulatory and Market Risks

• Despite the positive outlook, there are risks associated with product development, market success, and competition. Challenges include obtaining and protecting intellectual property rights, managing patent expirations, and navigating increasingly aggressive competition from biosimilars and generics[2].

Economic and Healthcare Trends

• The healthcare market is subject to various pressures, including trends toward cost containment, consolidation among healthcare providers, and government pressure to reduce costs. These factors could impact the pricing and adoption of OPSYNVI[2][5].

Key Takeaways

• Clinical Efficacy: OPSYNVI has demonstrated superior efficacy in reducing Pulmonary Vascular Resistance compared to monotherapies.
• Market Positioning: Johnson & Johnson now offers a comprehensive PAH portfolio addressing all three foundational pathways.
• Regulatory Considerations: OPSYNVI comes with a Boxed Warning and requires enrollment in a REMS program.
• Financial Impact: Expected to contribute to Johnson & Johnson's revenue growth within the Innovative Medicine segment.
• Risks and Challenges: Includes regulatory, market, and economic risks that could affect adoption and pricing.

FAQs

Q1: What is OPSYNVI, and how does it differ from existing PAH treatments?

• OPSYNVI is a once-daily single-tablet combination therapy combining macitentan and tadalafil, approved for the treatment of Pulmonary Arterial Hypertension (PAH). It differs from existing treatments by offering a more convenient dosing regimen and superior efficacy in reducing Pulmonary Vascular Resistance.

Q2: What are the key findings from the Phase 3 A DUE study?

• The Phase 3 A DUE study demonstrated that OPSYNVI achieved a greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks compared to tadalafil or macitentan monotherapy.

Q3: What are the safety concerns associated with OPSYNVI?

• OPSYNVI has a Boxed Warning due to the risk of embryo-fetal toxicity and requires female patients to enroll in the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS) program.

Q4: How does OPSYNVI fit into Johnson & Johnson's PAH treatment portfolio?

• With the approval of OPSYNVI, Johnson & Johnson now offers a comprehensive PAH portfolio that addresses all three foundational and guideline-recommended pathways for this disease: nitric oxide, endothelin, and prostacyclin.

Q5: What are the potential financial implications of OPSYNVI for Johnson & Johnson?

• The approval of OPSYNVI is expected to contribute to Johnson & Johnson's revenue growth within the Innovative Medicine segment, aligning with the company's overall strategy of delivering innovative medicines and driving sales growth.

Sources

1. U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH) - Johnson & Johnson.
2. Johnson & Johnson Form 10-K 2023 - Johnson & Johnson.
3. Q4 2023 Johnson & Johnson Earnings Call - Johnson & Johnson.
4. U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH) - PR Newswire.
5. 2023 Annual Report - Johnson & Johnson.