Vorapaxar sulfate - Generic Drug Details

What are the generic 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 are two patents 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:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	19
DailyMed Link:	vorapaxar sulfate at DailyMed

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

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
Merck Sharp & Dohme Corp.	Phase 2
Matthew Mell	Phase 2
Ken Mahaffey	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			Y	Y
Key Therap	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014		DISCN	Yes	No			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
Key Therap	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014

International Patents for vorapaxar sulfate

Country	Patent Number	Title	Estimated Expiration
South Korea	20030008161	트롬빈 수용체 길항제 (Thrombin receptor antagonists)
Russian Federation	2329264	ТРИЦИКЛИЧЕСКИЕ АНТАГОНИСТЫ ТРОМБИНОВОГО РЕЦЕПТОРА (TRICYCLIC ANTAGONISTS OF THROMBIN RECEPTORS)
Australia	2004289310	Methods of use of thrombin receptor antagonists
Malaysia	143834	THROMBIN RECEPTOR ANTAGONISTS
Spain	2297150
European Patent Office	1294714	ANTAGONISTES DU RECEPTEUR DE LA THROMBINE (THROMBIN RECEPTOR ANTAGONISTS)
Hong Kong	1151285	凝血酶受體拮抗劑的硫酸氫鹽的結晶多晶型物 (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	C01495018/01	Switzerland		PRODUCT NAME: VORAPAXAR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65803 19.09.2016
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	C20150025 00159	Estonia		PRODUCT NAME: VORAPAKSAAR;REG NO/DATE: EU/1/14/976 21.01.2015
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	2015C/037	Belgium		PRODUCT NAME: VORAPAXAR, OU SON SEL OU SOLVAT PHARMACOLOGIQUEMENT ADMISSIBLE; AUTHORISATION NUMBER AND DATE: EU/1/14/976/001
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	C300746	Netherlands		PRODUCT NAME: VORAPAXAR IN ELKE DOOR HET; REGISTRATION NO/DATE: EU/1/14/976/001-006 20150119

Vorapaxar sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vorapaxar Sulfate

Introduction

Vorapaxar sulfate, marketed under the brand name ZONTIVITY, is a reversible antagonist of the protease-activated receptor-1 (PAR-1) expressed on platelets. It is primarily used to reduce the risk of heart attacks and strokes in patients with a history of heart disease. Here, we delve into the market dynamics and financial trajectory of vorapaxar sulfate.

Mechanism of Action and Clinical Use

Vorapaxar inhibits thrombin-induced and thrombin receptor agonist peptide (TRAP)-induced platelet aggregation, making it an effective antiplatelet agent. It does not affect coagulation parameters or platelet aggregation induced by other factors like adenosine diphosphate (ADP), collagen, or a thromboxane mimetic[3].

Market Size and Growth

The global vorapaxar sulfate market has been experiencing significant growth. As of 2023, the market size was valued at USD 105.6 billion and is projected to reach USD 148.9 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.5%[4].

Key Market Drivers

Several factors are driving the growth of the vorapaxar sulfate market:

Increasing Prevalence of Cardiovascular Diseases

The rising incidence of cardiovascular diseases, such as heart attacks and strokes, is a major driver. As the global population ages and lifestyle factors contribute to increased cardiovascular risk, the demand for effective antiplatelet agents like vorapaxar sulfate is expected to rise[3].

Innovative Therapies

The development of new therapeutic approaches and the approval of vorapaxar sulfate for various indications, including Peripheral Artery Disease (PAD), have expanded its market potential. The drug's unique mechanism of action sets it apart from other antiplatelet agents[3].

Regulatory Milestones

Regulatory approvals and milestones have been crucial in the market growth of vorapaxar sulfate. Detailed reports on its regulatory status and developmental activities provide a clear picture of its market trajectory[3].

Competitive Landscape

The market for vorapaxar sulfate is competitive, with several key players involved in its development and distribution. Here are some key aspects of the competitive landscape:

Market Competitors

The report highlights comprehensive coverage of market competitors, including their market ranks and competitive strategies. Companies are developing therapies that focus on novel approaches to treat cardiovascular diseases, which could influence vorapaxar sulfate's market dominance[3].

Emerging Therapies

Other emerging products for PAD and cardiovascular diseases are expected to provide significant market competition. The launch of late-stage emerging therapies in the near future will impact the market dynamics of vorapaxar sulfate[3].

Financial Trajectory

Revenue Projections

The financial trajectory of vorapaxar sulfate is promising, with forecasted sales data indicating significant growth. The market is expected to expand due to extensive research and incremental healthcare spending globally. By 2032, the forecasted sales of vorapaxar sulfate for PAD in the six major markets (the United States, EU4, and the United Kingdom) are expected to be substantial, supporting the decision-making process for therapeutic portfolios[3].

Pricing and Discounts

The pricing strategy for vorapaxar sulfate is influenced by factors such as invoice price changes, off-invoice discounts, and rebates. While the invoice prices for branded products have risen, net price growth is substantially lower due to these discounts and rebates. This dynamic affects the overall revenue and profitability of the drug[2].

Clinical Trials and Development

Vorapaxar sulfate has undergone various clinical trials to assess its efficacy and safety:

Phase 4 Trials

Several Phase 4 trials have been conducted, including studies on the combination of vorapaxar with other antiplatelet agents like clopidogrel, prasugrel, and ticagrelor. These trials aim to evaluate the long-term outcomes and safety profiles of these combinations[5].

Regulatory Status

The drug has achieved significant regulatory milestones, including approvals for its use in PAD and other cardiovascular conditions. The report provides detailed insights into these regulatory achievements and their impact on the market[3].

Market Insights by Region

The market for vorapaxar sulfate varies by region, with different countries having different regulatory environments and healthcare spending patterns:

United States and Europe

The report provides a detailed market assessment for the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom. These regions are expected to drive the growth of the vorapaxar sulfate market due to high healthcare spending and the prevalence of cardiovascular diseases[3].

SWOT Analysis

A SWOT analysis of vorapaxar sulfate highlights its strengths, weaknesses, opportunities, and threats:

Strengths

• Unique mechanism of action
• Regulatory approvals
• Growing demand for antiplatelet agents

Weaknesses

• Long half-life making it effectively irreversible
• Potential side effects and safety concerns

Opportunities

• Expanding indications for PAD and other cardiovascular diseases
• Increasing healthcare spending globally

Threats

• Emerging competitors and new therapies
• Patent expiries and generic competition[3].

Key Takeaways

• Vorapaxar sulfate is a significant player in the antiplatelet market with a unique mechanism of action.
• The global market for vorapaxar sulfate is projected to grow at a CAGR of 6.5% from 2023 to 2031.
• Regulatory approvals and clinical trials are crucial for its market trajectory.
• The drug faces competition from emerging therapies and generic alternatives.
• Market dynamics are influenced by pricing strategies, discounts, and rebates.

FAQs

What is the primary mechanism of action of vorapaxar sulfate?

Vorapaxar sulfate is a reversible antagonist of the protease-activated receptor-1 (PAR-1) expressed on platelets, inhibiting thrombin-induced and TRAP-induced platelet aggregation[3].

What are the key indications for vorapaxar sulfate?

Vorapaxar sulfate is primarily used to reduce the risk of heart attacks and strokes in patients with a history of heart disease, including Peripheral Artery Disease (PAD)[3].

How does the pricing strategy affect the revenue of vorapaxar sulfate?

The pricing strategy is influenced by invoice price changes, off-invoice discounts, and rebates, which can reduce the net price growth and impact the overall revenue and profitability[2].

What are the major regions driving the growth of the vorapaxar sulfate market?

The United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom are the major regions driving the growth of the vorapaxar sulfate market due to high healthcare spending and the prevalence of cardiovascular diseases[3].

What are the potential threats to the market dominance of vorapaxar sulfate?

Emerging competitors, new therapies, and patent expiries leading to generic competition are potential threats to the market dominance of vorapaxar sulfate[3].

Sources

1. Global Vorapaxar Sulfate Market Research Report 2024 - Market Research Reports[1].
2. Medicines Use and Spending Shifts - IQVIA[2].
3. ZONTIVITY Market Size, Forecast and Market Insight 2024-2032 - GlobeNewswire[3].
4. Vorapaxar Sulfate Market Size, Trends and Projections - Market Research Intellect[4].
5. Vorapaxar Sulfate - Drug Targets, Indications, Patents - Synapse[5].