VORAPAXAR SULFATE - Generic Drug Details

What are the generic sources for vorapaxar sulfate and what is the scope of patent protection?

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
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
DailyMed Link:	VORAPAXAR SULFATE at DailyMed

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.

Recent Clinical Trials for VORAPAXAR SULFATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Matthew Mell	Phase 2
Ken Mahaffey	Phase 2
Merck Sharp & Dohme Corp.	Phase 2

See all VORAPAXAR SULFATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for VORAPAXAR SULFATE

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

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
Mexico	PA02012447	ANTAGONISTAS RECEPTORES DE TROMBINA. (THROMBIN RECEPTOR ANTAGONISTS.)
New Zealand	523075	Thrombin receptor antagonists
South Korea	20080100497	PROCESS FOR PREPARING CRYSTALLINE POLYMORPH OF A BISULFATE SALT OF A THROMBIN RECEPTOR ANTAGONIST
Mexico	PA06007830	POLIMORFO CRISTALINO DE UNA SAL DE BISULFATO DE UN ANTAGONISTA DEL RECEPTOR DE TROMBINA. (CRYSTALLINE POLYMORPH OF A BISULFATE SALT OF A THROMBIN RECEPTOR ANTAGONIST.)
Japan	2007510750

Supplementary Protection Certificates for VORAPAXAR SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1495018	122015000053	Germany		PRODUCT NAME: VORAPAXAR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/14/976/001-006 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	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	CR 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	2015C/037	Belgium		PRODUCT NAME: VORAPAXAR, OU SON SEL OU SOLVAT PHARMACOLOGIQUEMENT ADMISSIBLE; AUTHORISATION NUMBER AND DATE: EU/1/14/976/001

Market Dynamics and Financial Trajectory for VORAPAXAR SULFATE

Last updated: February 15, 2026

Overview

VORAPAXAR SULFATE is an oral protease-activated receptor-1 (PAR-1) antagonist under development targeting thrombotic cardiovascular conditions. Its market prospects depend heavily on clinical trial outcomes, regulatory approvals, competitive landscape, and strategic partnerships. Currently, it remains in the investigational stage with no regulatory approval or commercial sales.

Market Size and Potential

The global antithrombotic therapy market was valued at approximately $11.8 billion in 2022 and is projected to reach $15.6 billion by 2027, growing at a compound annual growth rate (CAGR) of 5.7%. The segment includes anticoagulants and antiplatelet agents treating conditions like atrial fibrillation, PCI, stroke, and acute coronary syndromes (ACS).

VORAPAXAR's indications are primarily in secondary prevention of thrombotic events in myocardial infarction (MI) and stroke. If approved, it could target a subset of this market, depending on its positioning and differentiation from existing therapies such as:

• P2Y12 inhibitors (clopidogrel, ticagrelor)
• PAR-1 antagonists (e.g., SCH 530348, vorapaxar's development code)

Clinical Trials and Regulatory Pathway

VORAPAXAR completed Phase III trials (TRACER and TRA 2°P-TIMI 50). These demonstrated reduction in ischemic events but increased bleeding risk. As of 2022, development was ongoing, with regulatory discussions likely contingent on balancing efficacy and safety.

• Key Data Points:
  • In TRA 2°P-TIMI 50, vorapaxar reduced recurrent myocardial infarction and ischemic stroke but raised concerns about bleeding, especially intracranial hemorrhage.
  • Regulatory agencies like FDA and EMA have previously issued black box warnings, impacting market perception.

New clinical data or label adjustments will influence market adoption. A favorable outcome would position VORAPAXAR strongly within secondary prevention.

Competitive Landscape

VORAPAXAR faces competition from a spectrum of antiplatelet and anticoagulant drugs, including:

Drug Class	Leading Agents	Market Share (2022)	Key Differentiator
P2Y12 inhibitors	Clopidogrel, Ticagrelor	Clopidogrel (~50%), Ticagrelor (~30%)	Broad acceptance, established safety profiles
PAR-1 antagonists	Vorapaxar (VORAPAXAR)	Development stage, no approval	Once-daily oral, novel mechanism, bleeding trade-offs
Direct oral anticoagulants (DOACs)	Rivaroxaban, Apixaban	Rivaroxaban (~40%), Apixaban (~30%)	Broader indications, easier dosing

Market Penetration Factors

• Safety profile: Bleeding risk remains a critical barrier.
• Clinical efficacy: Must demonstrate superiority or added benefit.
• Regulatory status: Approval in key markets (US, Europe, Asia).
• Pricing strategy: Competitive positioning relative to existing therapies.
• Physician acceptance: Based on trial data, safety, and cost.

Financial Trajectory

Since VORAPAXAR remains investigational, detailed revenue forecasts involve speculation:

Scenario	Assumptions	Implications
Optimistic	Approval received 2025, high adoption, premium pricing	Peak sales could reach $1-2 billion annually
Moderate	Conditional approval, cautious market penetration	Peak sales around $500 million annually
Pessimistic	Clinical setbacks, safety concerns, delayed approval	Limited or no commercialization

• Pre-approval phase costs: R&D, clinical trial expenses, regulatory submissions likely exceed $1 billion cumulatively, depending on trial size.
• Post-approval sales: Regulatory approval can take 2-5 years post-trials, with commercialization efforts and market access negotiations influencing revenue flow.

Investment Considerations

• Large pharmaceutical companies with cardiovascular portfolios (e.g., AstraZeneca, Bayer) may seek licensing or acquisition opportunities.
• Track record of previous PAR-1 antagonists suggests high risk but high reward potential.
• Patent protection expected into the mid-2030s could bolster market exclusivity if approved.

Conclusion

VORAPAXAR SULFATE's market success hinges on overcoming safety concerns, demonstrating clear clinical benefit, and securing regulatory approval. Its financial trajectory remains speculative until definitive trial results and approvals are secured. The drug's potential lies within a competitive but expanding antithrombotic market, targeting unmet needs in secondary prevention.

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Key Takeaways

• VORAPAXAR is an investigational PAR-1 antagonist with potential in secondary prevention of thrombotic events.
• The drug faces significant safety and efficacy hurdles; its approval timeline remains uncertain.
• Its market size could reach hundreds of millions to billions annually if approved, but competitive dynamics complicate penetration.
• Successful commercialization depends on clinical outcomes, regulatory positioning, and physician acceptance.
• Strategic partnerships or licensing agreements are probable pathways for commercialization.

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FAQs

1. What is the primary indication for VORAPAXAR?
It targets secondary prevention of thrombotic cardiovascular events, such as MI and stroke.

2. What are the main safety concerns associated with VORAPAXAR?
The primary concern is increased bleeding risk, particularly intracranial hemorrhage, as observed in clinical trials.

3. How does VORAPAXAR compare to existing antithrombotic therapies?
It offers a novel mechanism through PAR-1 antagonism but faces similar bleeding risks as other agents; its advantage depends on clinical efficacy and safety improvements.

4. What is the expected timeline for commercialization?
Pending positive trial results and regulatory approval, market entry could occur around 2025-2026.

5. Which companies are likely to be interested in VORAPAXAR?
Large pharma firms with cardiology portfolios, such as Bayer, AstraZeneca, or Pfizer, may pursue licensing, partnership, or acquisition.

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References

1. Market data from Transparency Market Research, 2022.
2. Clinical trial results from the TRA 2°P-TIMI 50 trial, 2012.
3. FDA and EMA regulatory notices, 2014/2015.
4. Competitive landscape analysis, IQVIA, 2022.
5. Patent filings and development timelines, public patent databases, 2022.