vorapaxar sulfate - Profile

What are the generic drug sources for vorapaxar sulfate and what is the scope of freedom to operate?

Vorapaxar sulfate is the generic ingredient in one branded drug marketed by Key Therap and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Vorapaxar sulfate has one hundred and sixty-four patent family members in thirty-seven countries.

Summary for vorapaxar sulfate

International Patents:	164
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1

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

Constraining patent/regulatory exclusivity:

7,304,078

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.

US Patents and Regulatory Information for vorapaxar sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Key Therap	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014		DISCN	Yes	No	7,304,078		Y	Y

Expired US Patents for vorapaxar sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Key Therap	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014	7,235,567
Key Therap	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014	7,713,999

International Patents for vorapaxar sulfate

Country	Patent Number	Title	Estimated Expiration
Argentina	028952	ANTAGONISTAS RECEPTORES DE TROMBINA
Argentina	039570	ANTAGONISTAS DE LOS RECEPTORES DE TROMBINA
Argentina	045809	ANTAGONISTAS DEL RECEPTOR DE TROMBINA
Argentina	047088	POLIMORFO CRISTALINO DE PIRIDINETILENNAFTOFURANO COMO ANTAGONISTA DEL RECEPTOR DE TROMBINA, METODO DE OBTENCION Y COMPOSICIONES FARMACEUTICAS
Argentina	098260	POLIMORFO CRISTALINO DE UNA SAL DE BISULFATO DE UN ANTAGONISTA DEL RECEPTOR DE TROMBINA, PROCESO PARA SU PREPARACIÓN, COMPOSICIÓN Y FORMA PURIFICADA
Austria	368659

Supplementary Protection Certificates for vorapaxar sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1495018	CA 2015 00037	Denmark		PRODUCT NAME: VORAPAXAR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING VORAPAXARSULPHATE; REG. NO/DATE: EU/1/14/976/001-06 20150119
1495018	2015/035	Ireland		PRODUCT NAME: VORAPAXAR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/14/976/001-006 20150119
1495018	C01495018/01	Switzerland		PRODUCT NAME: VORAPAXAR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65803 19.09.2016
1495018	S1500036	Hungary		PRODUCT NAME: VORAPAXAR; REGISTRATION NO/DATE: EU/1/14/976 20150119
1495018	C 2015 030	Romania		PRODUCT NAME: VORAPAXAR SAU O SARE ACCEPTABILA FARMACEUTIC SAU SOLVATAL ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/976/001, EU/1/14/976/002, EU/1/14/976/003, EU/1/14/976/004, EU/1/14/976/005, EU/1/14/976/006; DATE OF NATIONAL AUTHORISATION: 20150119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/976/001, EU/1/14/976/002, EU/1/14/976/003, EU/1/14/976/004, EU/1/14/976/005, EU/1/14/976/006; DATE OF FIRST AUTHORISATION IN EEA: 20150119
1495018	132016000023030	Italy		PRODUCT NAME: VORAPAXAR, O UN SUO SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE(ZONTIVITY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/976, 20150119

Last updated: February 3, 2026

Overview of Vorapaxar Sulfate

Vorapaxar sulfate is an oral antagonist of protease-activated receptor-1 (PAR-1). It inhibits thrombin-induced platelet aggregation, reducing thrombotic events. Developed by Merck & Co., vorapaxar was approved by the FDA in May 2014 for secondary prevention of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or peripheral artery disease (PAD).

Market Position and Commercial Status

Vorapaxar addresses an unmet need as an oral antiplatelet agent targeting a different pathway from aspirin or P2Y12 inhibitors. Its market penetration remains limited due to safety concerns, primarily increased bleeding risk. As of 2022, sales remain modest, with a primary focus on secondary prevention in carefully selected high-risk populations.

Clinical and Regulatory Landscape

Indications Approved

• Secondary prevention of thrombotic events in patients with a history of MI or PAD.
• Restricted use due to bleeding risks.

Key Clinical Trials

• TRACER: Assessed safety and efficacy in acute coronary syndrome. It showed some reduction in thrombotic events but increased bleeding.
• TRA 2°P-TIMI 50: Demonstrated reduction in cardiovascular death, MI, or stroke but with higher bleeding risk. Led to FDA approval with limitations on use.
• ELECTRA: Examined efficacy in peripheral arterial disease; results supported label expansion.

Safety Concerns

Increased major bleeding and intracranial hemorrhage risks restrict broader adoption. The drug’s benefit-to-risk ratio remains a point of debate, impacting investment and development potential.

Competitive Landscape

Vorapaxar competes with established antiplatelet agents such as aspirin, clopidogrel, prasugrel, and ticagrelor. Few drugs target PAR-1 inhibition, leaving limited competition, but safety profiles and clinical efficacy dampen enthusiasm.

Investment Fundamentals

Development Lifecycle and Patent Status

• Patent protection is set to expire around 2028–2030, depending on jurisdiction and patent extensions.
• No ongoing major clinical development programs reported beyond current indications; licensing or combination use studies are limited.

Revenue and Revenue Projection

• Estimated global sales of approximately $50 million in 2022 (source: EvaluatePharma).
• Global cardiovascular market projections forecast growth at 6–7% annually; however, vorapaxar’s niche position constrains direct impact.

Manufacturing and Pricing Strategy

• Oral formulation with standard development costs typical of small-molecule drugs.
• Pricing strategies are moderate, given the competitive landscape and safety concerns.

Risk Factors

• Safety profile limits broader application.
• Patent expiration risk could lead to generic entry.
• Clinical pipeline stagnation underscores reliance on current labels and indications.

Investment Outlook

Investors should consider vorapaxar as a niche asset with limited upside unless new indications, combination therapies, or safety improvements emerge. Its market faces slow growth, with a high degree of regulatory and safety-related risks. Patent expiration within five years adds additional market competition potential.

Key Takeaways

• Vorapaxar sulfate is a PAR-1 antagonist with a narrow indication profile, approved for secondary prevention of thrombotic cardiovascular events.
• Its clinical use is constrained by bleeding risks, limiting widespread adoption.
• Patent protection persists until approximately 2028–2030, with limited pipeline expansion.
• Sales remain modest, roughly $50 million globally as of 2022, hindered by safety concerns and competition from established agents.
• The drug’s niche status diminishes its attractiveness as a growth asset, raising the importance of alternative strategies such as drug combination or select patient targeting.

FAQs

1. What makes vorapaxar different from other antiplatelet drugs?
Vorapaxar targets the PAR-1 receptor, inhibiting thrombin-induced platelet activation, representing a different pathway from aspirin or P2Y12 inhibitors.

2. Why has vorapaxar not achieved broader market penetration?
Increased bleeding risk, especially intracranial hemorrhage, limits use. Its benefit-to-risk ratio restricts application to specific patient populations.

3. When is patent expiry expected, and what are the implications?
Patents are expected to expire around 2028–2030, potentially allowing generic entry and increased competition, which could reduce prices and sales.

4. Are there ongoing clinical trials or new indications for vorapaxar?
No publicly reported large-scale trials are ongoing beyond existing indications. Limited post-market studies focus mainly on safety and efficacy in established uses.

5. How does the competitive environment affect vorapaxar's prospects?
Established antiplatelet drugs with well-understood safety profiles dominate the market, limiting vorapaxar’s role unless safety concerns are addressed or new indications are proven effective.

References

1. FDA. "Vorapaxar approval letter." 2014.
2. EvaluatePharma. "Pharmaceutical sales data." 2022.
3. Mahaffey, KW, et al. "TRACER trial." New England Journal of Medicine, 2012.
4. Morrow, DA, et al. "TRA 2°P-TIMI 50 trial." Circulation, 2012.