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ZONTIVITY Drug Patent Profile

Which patents cover Zontivity, and when can generic versions of Zontivity launch?

Zontivity is a drug marketed by Key Therap and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and sixty-four patent family members in thirty-seven countries.

The generic ingredient in ZONTIVITY is vorapaxar sulfate. Additional details are available on the vorapaxar sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Zontivity

Zontivity was eligible for patent challenges on May 8, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 23, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZONTIVITY

International Patents:	164
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	5
Patent Applications:	6
Drug Prices:	Drug price information for ZONTIVITY
What excipients (inactive ingredients) are in ZONTIVITY?	ZONTIVITY excipients list
DailyMed Link:	ZONTIVITY at DailyMed

See drug prices for ZONTIVITY

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

Constraining patent/regulatory exclusivity:

7,304,078

NDA:

204886

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 ZONTIVITY

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

Sponsor	Phase
Vanderbilt University Medical Center	Phase 4
Vanderbilt University	Phase 4
Merck Sharp & Dohme Corp.	Phase 4

See all ZONTIVITY clinical trials

US Patents and Regulatory Information for ZONTIVITY

ZONTIVITY is protected by two US patents.

This potential generic entry date is based on patent 7,304,078.

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
Key Therap	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014		DISCN	Yes	No	7,713,999		Y	Y
Key Therap	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014		DISCN	Yes	No	7,304,078		Y	Y

Expired US Patents for ZONTIVITY

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 ZONTIVITY

See the table below for patents covering ZONTIVITY around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	455774
South Korea	20060113758	CRYSTALLINE POLYMORPH OF A BISULFATE SALT OF A THROMBIN RECEPTOR ANTAGONIST
Russian Federation	2355689	КРИСТАЛЛИЧЕСКАЯ ПОЛИМОРФНАЯ ФОРМА БИСУЛЬФАТНОЙ СОЛИ АНТАГОНИСТА ТРОМБИНОВОГО РЕЦЕПТОРА (CRYSTALLINE POLYMORPHOUS FORM OF THROMBIN RECEPTOR ANTAGONIST BISULFATE)
Australia	2004289310	Methods of use of thrombin receptor antagonists

Supplementary Protection Certificates for ZONTIVITY

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

ZONTIVITY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZONTIVITY

Introduction to ZONTIVITY

ZONTIVITY, also known as vorapaxar, is a first-in-class PAR-1 antagonist approved by the FDA in 2014 for the reduction of thrombotic cardiovascular events in patients with a history of heart attack (myocardial infarction) or peripheral arterial disease (PAD)[4].

Mechanism of Action and Clinical Benefits

ZONTIVITY works by inhibiting the protease-activated receptor-1 (PAR-1) on platelets, which plays a crucial role in platelet activation and aggregation. This mechanism helps in reducing the risk of cardiovascular death, myocardial infarction, stroke, and urgent coronary revascularization (UCR) in patients with a history of heart attack or PAD. Clinical trials have shown a significant 17% relative risk reduction in these combined events over three years when ZONTIVITY is added to standard care, including aspirin and/or clopidogrel[4].

Market Assessment and Forecast

The market for ZONTIVITY is assessed across six major markets: the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom. The report by ResearchAndMarkets.com provides a comprehensive market forecast from 2024 to 2032, highlighting the potential growth and challenges in the PAD market. The market is expected to expand due to extensive research and increased healthcare spending globally[1].

Sales and Revenue Projections

Historical data indicates that ZONTIVITY has seen steady growth in prescriptions. For instance, Aralez forecasted a significant increase in total ZONTIVITY prescriptions from 2017 to 2018, aiming for a market share of 0.9% which corresponded to approximately $15 million in revenues. The long-term projection suggests peak sales of around $150 million[2].

Competitive Landscape

The PAD market is competitive, with several emerging therapies that could challenge ZONTIVITY's market position. The report highlights other late-stage emerging therapies under development, which are expected to impact the market significantly. Companies are focusing on novel approaches to treat PAD, which could alter the market dynamics and competition for ZONTIVITY[1].

Dosage and Administration

ZONTIVITY is administered as a single tablet of 2.08 mg once daily, taken orally with or without food. It is always used in addition to aspirin and/or clopidogrel, as there is no experience with ZONTIVITY as the sole antiplatelet agent[1].

Regulatory Milestones and Development Activities

The drug has undergone significant regulatory milestones, including its FDA approval in 2014. The report provides detailed insights into the research and development activities, including clinical trials, trial interventions, and trial status. This includes information on regulatory approvals and patent expiry timelines, which are crucial for understanding the drug's market longevity[1].

Financial Performance and Projections

Aralez, the company behind ZONTIVITY, reported revenue growth and increased prescriptions in the initial years post-launch. The financial projections indicate that ZONTIVITY is expected to be a main revenue driver for the company, with peak sales forecasted at around $150 million. The company's adjusted EBITDA is projected to improve significantly over the next few years, driven by the growth in ZONTIVITY prescriptions and the performance of other products like Toprol-XL[2].

Cost Structure and Profitability

The cost structure for ZONTIVITY includes costs related to research and development, selling, general, and administrative expenses. The gross margin for the product is high, around 74%, indicating a profitable product. However, the company's overall profitability is influenced by various factors, including the cost of goods sold, SG&A expenses, and research and development costs[2].

Challenges and Opportunities

Bleeding Risks

One of the significant challenges for ZONTIVITY is the increased risk of bleeding, including GUSTO moderate or severe bleeding and intracranial hemorrhage (ICH). This risk profile can impact patient and physician adoption rates[4].

Market Competition

The PAD market is highly competitive, with new product launches and emerging therapies. This competition can erode market share and pricing power for ZONTIVITY. However, the drug's unique mechanism of action and clinical benefits provide a competitive edge[1].

Regulatory and Patent Environment

The patent expiry timeline and regulatory environment are critical for ZONTIVITY's market trajectory. The report highlights the patent information and expiry timeline, which is essential for understanding the drug's market exclusivity period[1].

Industry Dynamics

The pharmaceutical industry, particularly the cardiovascular segment, is driven by an aging population and scientific advancements. However, it is also characterized by moderate erosion in pricing power and abrupt revenue declines following patent expirations. These dynamics can impact the long-term financial trajectory of ZONTIVITY[3].

Key Takeaways

• ZONTIVITY is a first-in-class PAR-1 antagonist with significant clinical benefits in reducing thrombotic cardiovascular events.
• The market forecast indicates steady growth, driven by increased healthcare spending and research.
• The drug faces competition from emerging therapies and has a unique risk profile related to bleeding.
• Financial projections suggest ZONTIVITY will be a key revenue driver, with peak sales forecasted at around $150 million.
• The company's profitability is influenced by various cost structures and market dynamics.

FAQs

What is ZONTIVITY used for?

ZONTIVITY is used for reducing thrombotic cardiovascular events in patients with a history of heart attack or peripheral arterial disease (PAD)[4].

How is ZONTIVITY administered?

ZONTIVITY is administered as a single tablet of 2.08 mg once daily, taken orally with or without food, always in addition to aspirin and/or clopidogrel[1].

What are the key clinical benefits of ZONTIVITY?

ZONTIVITY reduces the risk of cardiovascular death, myocardial infarction, stroke, and urgent coronary revascularization (UCR) by 17% over three years when added to standard care[4].

What are the potential risks associated with ZONTIVITY?

ZONTIVITY is associated with an increased risk of bleeding, including GUSTO moderate or severe bleeding and intracranial hemorrhage (ICH)[4].

What is the forecasted market scenario for ZONTIVITY?

The market for ZONTIVITY is expected to grow, driven by increased healthcare spending and research, with forecasted sales data available until 2032[1].

Sources:

1. GlobeNewswire - ZONTIVITY Market Size, Forecast and Market Insight 2024-2032
2. Zacks Small-Cap Research - Aralez Financial Results and Forecast
3. S&P Global - Mortality In Health Care: What Factors Lead To Default For Pharmaceutical Companies
4. Merck - FDA Approves ZONTIVITY™ (vorapaxar) for the Reduction of Thrombotic Cardiovascular Events