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
Ken Mahaffey	Phase 2
Merck Sharp & Dohme Corp.	Phase 2
Matthew Mell	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
World Intellectual Property Organization (WIPO)	0196330
Mexico	PA06003379	ANTAGONISTAS DEL RECEPTOR DE TROMBINA. (THROMBIN RECEPTOR ANATGONISTS.)
Russian Federation	2006128779	КРИСТАЛЛИЧЕСКАЯ ПОЛИМОРФНАЯ ФОРМА БИСУЛЬФАТНОЙ СОЛИ АНТАГОНИСТА ТРОМБИНОВОГО РЕЦЕПТОРА
European Patent Office	2277879	Polymorphe cristallin d'un sel bisulfate d'un antagoniste de récepteur de thrombine (Crystalline polymorph of a bisulfate salt of a thrombin receptor antagonist)

Supplementary Protection Certificates for VORAPAXAR SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	SPC/GB15/039	United Kingdom		PRODUCT NAME: VORAPAXAR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/14/976/001 20150121; UK EU/1/14/976/002 20150121; UK EU/1/14/976/003 20150121; UK EU/1/14/976/004 20150121; UK EU/1/14/976/005 20150121; UK EU/1/14/976/006 20150121
1495018	2015C/037	Belgium		PRODUCT NAME: VORAPAXAR, OU SON SEL OU SOLVAT PHARMACOLOGIQUEMENT ADMISSIBLE; AUTHORISATION NUMBER AND DATE: EU/1/14/976/001
1495018	122015000053	Germany		PRODUCT NAME: VORAPAXAR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/14/976/001-006 20150119

Market Dynamics and Financial Trajectory for VORAPAXAR SULFATE

Last updated: July 29, 2025

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Introduction

VORAPAXAR SULFATE, a novel selective protease-activated receptor-1 (PAR-1) antagonist, offers promising pathways in the management of thrombotic and cardiovascular diseases. As the pharmaceutical industry intensifies focus on anti-thrombotic therapies, understanding the market dynamics and financial trajectory of VORAPAXAR SULFATE becomes vital for stakeholders—pharmaceutical companies, investors, and healthcare policymakers. This analysis provides a comprehensive overview of factors shaping its market landscape and financial prospects.

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Market Landscape and Trends

Unmet Medical Need and Competitive Landscape

VORAPAXAR SULFATE targets a significant unmet need in preventing arterial thromboembolism, particularly in patients intolerant to existing therapies like aspirin or warfarin. The drug's mechanism—selective PAR-1 antagonism—positions it distinctively within the antithrombotic class, offering potential safety advantages over traditional agents that increase bleeding risk.

Competitors include established drugs such as vorapaxar (Zontivity), a PAR-1 antagonist approved for secondary prevention in cardiovascular disease, and newer agents exploring similar pathways. The competitive landscape is characterized by ongoing clinical trials, regulatory strategies, and market penetration efforts that influence market share expansion potential for VORAPAXAR SULFATE.

Regulatory Environment

Regulatory pathways significantly influence market dynamics. The drug is currently in late-phase clinical trials, with subsequent approval processes dictating time-to-market and market entry costs. The FDA and EMA's evolving guidance on anticoagulants focusing on bleeding risk profiles could either accelerate or impede commercialization.

Rapid regulatory approval, underpinned by compelling clinical data demonstrating superior safety and efficacy, could catalyze early market capture. Conversely, regulatory hesitancy stemming from safety concerns may delay or constrain adoption, shaping the financial outlook accordingly.

Clinical Development and Data Outlook

Robust clinical trial outcomes demonstrating VORAPAXAR SULFATE's efficacy in reducing thrombotic events with acceptable safety profiles will be critical. Positive trial results tend to bolster market confidence, attract licensing deals, and bolster revenue forecasts, while adverse findings could lead to reevaluation or withdrawal, negatively impacting valuation.

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Market Drivers

• Aging Population and Rising Cardiovascular Disease Incidence: The global increase in elderly populations coupled with the rising prevalence of atherosclerotic cardiovascular diseases (ASCVD) fuels demand for effective antithrombotic agents.

• Limitations of Current Therapies: Bleeding risks associated with conventional anticoagulants, and patient intolerance to drugs like aspirin, motivate the adoption of novel agents such as VORAPAXAR SULFATE, promising improved safety.

• Regulatory and Technological Innovations: Advances in pharmacogenomics and personalized medicine pave the way for tailored therapies, enhancing the appeal of VORAPAXAR SULFATE for specific patient subsets.

• Strategic Collaborations: Partnerships with biotech firms, clinical research organizations, and healthcare providers accelerate development and global market access, influencing revenue streams.

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Market Challenges and Constraints

• Safety Concerns and Clinical Risks: Potential adverse effects, including bleeding and other off-target effects, could hamper market penetration if not mitigated through robust clinical data.

• Pricing and Reimbursement Dynamics: High R&D and clinical trial costs necessitate premium pricing; however, reimbursement policies vary geographically, influencing adoption rates and financial outcomes.

• Regulatory Delays and Clinical Failures: Unfavorable trial outcomes or regulatory bottlenecks could lead to significant financial losses, highlighting the importance of strategic planning in clinical development.

• Market Penetration Barriers: Competition from well-established therapies and late entrants may impede swift market capture.

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Financial Trajectory and Investment Outlook

Revenue Projections

If VORAPAXAR SULFATE successfully completes clinical development with favorable safety and efficacy data, early market entry can generate substantial revenues. Based on comparables like vorapaxar, sales could reach hundreds of millions annually within the first few years post-approval, contingent on market penetration strategies and patient acceptance.

Cost and Investment Considerations

• R&D Expenditure: Significant up-front investments in clinical trials accelerate toward regulatory approval milestones, impacting short-term profitability.

• Manufacturing and Scale-up Costs: To meet global demand, scalable manufacturing processes and supply chain efficiencies are essential, influencing overall cost structures.

• Market Access and Commercialization: Marketing campaigns, education initiatives, and reimbursement negotiations constitute substantial expenses, yet pivotal for maximizing financial return.

Long-term Outlook

A successful commercialization aligned with positive clinical data can lead to steady growth, driven by expanding indications (e.g., evolving anti-thrombotic needs) and potential combination therapies. Conversely, regulatory setbacks or clinical failures could diminish projected revenues, emphasizing the importance of strategic risk management.

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Conclusion

VORAPAXAR SULFATE’s market potential is underscored by its unique targeting mechanism and the global burden of cardiovascular diseases. Its financial trajectory hinges on clinical success, regulatory approvals, competitive positioning, and strategic collaborations. While promising, stakeholders must navigate clinical, regulatory, and market risks to realize its full commercial value.

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Key Takeaways

• The success of VORAPAXAR SULFATE depends on positive clinical trial outcomes that demonstrate safety and efficacy in reducing thrombotic events.
• Market penetration will be enhanced by addressing unmet needs, especially in patients intolerant to existing therapies.
• Navigating regulatory pathways efficiently can significantly impact the drug’s financial potential.
• Competitive dynamics involve existing PAR-1 antagonists and emerging agents, influencing market share and revenue streams.
• Cost management, pricing strategies, and reimbursement policies play critical roles in shaping the drug’s long-term financial trajectory.

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FAQs

1. What distinguishes VORAPAXAR SULFATE from existing anticoagulants?
VORAPAXAR SULFATE selectively targets PAR-1, aiming to reduce thrombotic risk while minimizing bleeding complications—a common adverse effect associated with traditional anticoagulants.

2. What is the current development status of VORAPAXAR SULFATE?
It is in late-stage clinical trials, with pivotal Phase III studies evaluating its safety and efficacy, prior to seeking regulatory approvals.

3. How does regulatory risk influence the financial outlook of VORAPAXAR SULFATE?
Regulatory approval is essential for commercialization. Delays or setbacks can postpone revenue generation and escalate costs, impacting overall investment returns.

4. Who are the primary competitors for VORAPAXAR SULFATE?
Existing drugs like vorapaxar (Zontivity) and emerging agents targeting similar pathways in thrombosis management serve as direct competitors.

5. What factors could accelerate the market adoption of VORAPAXAR SULFATE?
Positive clinical trial results, clear regulatory approval pathways, effective reimbursement strategies, and strong strategic collaborations can facilitate faster market adoption.

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References

1. [1] Clinical trial data and regulatory filings for VORAPAXAR SULFATE.
2. [2] Industry reports on anticoagulant markets and competitor analysis.
3. [3] FDA and EMA guidelines on anticoagulant drug approvals.
4. [4] Epidemiological studies on cardiovascular disease prevalence and impact.
5. [5] Financial models on drug commercialization and market forecasts.

Note: All references are indicative; actual sources should include detailed clinical trial results, regulatory filings, and market research reports.