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ZONTIVITY Drug Patent Profile

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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

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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

Drug patent expirations by year for ZONTIVITY

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

Generic Entry Date for ZONTIVITY^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
University of Florida	Phase 4

See all ZONTIVITY clinical trials

US Patents and Regulatory Information for ZONTIVITY

ZONTIVITY is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZONTIVITY is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ZONTIVITY

Thrombin receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS

Thrombin receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS IN PATIENTS WITH A HISTORY OF MYOCARDIAL INFARCTION (MI) OR WITH PERIPHERAL ARTERIAL DISEASE (PAD)

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Glossary

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

Expired US Patents for ZONTIVITY

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Key Therap	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014	⤷ Sign Up	⤷ Sign Up
Key Therap	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ZONTIVITY

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

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1070887	Tricyclic thrombin receptor antagonists	⤷ Sign Up
South Korea	101039973		⤷ Sign Up
Australia	6690001	Thrombin receptor antagonists	⤷ Sign Up
Japan	2007517804		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ZONTIVITY

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1495018	2015C/037	Belgium	⤷ Sign Up	PRODUCT NAME: VORAPAXAR, OU SON SEL OU SOLVAT PHARMACOLOGIQUEMENT ADMISSIBLE; AUTHORISATION NUMBER AND DATE: EU/1/14/976/001
1495018	SPC/GB15/039	United Kingdom	⤷ Sign Up	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	CA 2015 00037	Denmark	⤷ Sign Up	PRODUCT NAME: VORAPAXAR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING VORAPAXARSULPHATE; REG. NO/DATE: EU/1/14/976/001-06 20150119
1495018	218 50011-2015	Slovakia	⤷ Sign Up	PRODUCT NAME: VORAPAXARIUMSULFAT; REGISTRATION NO/DATE: EU/1/14/976/001 - EU/1/14/976/006 20150121
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description