Vorapaxar sulfate - Generic Drug Details

What are the generic drug 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 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		RX	Yes	Yes			Y	Y
Key Therap	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014		RX	Yes	Yes			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
Taiwan	200524914	Thrombin receptor antagonists
Norway	20061797
Russian Federation	2008106401	ТРИЦИКЛИЧЕСКИЕ АНТАГОНИСТЫ ТРОМБИНОВОГО РЕЦЕПТОРА
Taiwan	200404068	Thrombin receptor antagonists
Slovakia	287026
Mexico	PA06003379	ANTAGONISTAS DEL RECEPTOR DE TROMBINA. (THROMBIN RECEPTOR ANATGONISTS.)
World Intellectual Property Organization (WIPO)	2005046688

Supplementary Protection Certificates for vorapaxar sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C01495018/01	Switzerland		PRODUCT NAME: VORAPAXAR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65803 19.09.2016
1495018	C20150025 00159	Estonia		PRODUCT NAME: VORAPAKSAAR;REG NO/DATE: EU/1/14/976 21.01.2015
1495018	PA2015027,C1495018	Lithuania		PRODUCT NAME: VORAPAKSARAS; REGISTRATION NO/DATE: EU/1/14/976/001 - EU/1/14/976/006 20150119
1495018	218 50011-2015	Slovakia		PRODUCT NAME: VORAPAXARIUMSULFAT; REGISTRATION NO/DATE: EU/1/14/976/001 - EU/1/14/976/006 20150121
1495018	C300746	Netherlands		PRODUCT NAME: VORAPAXAR IN ELKE DOOR HET; REGISTRATION NO/DATE: EU/1/14/976/001-006 20150119
1495018	PA2015027	Lithuania		PRODUCT NAME: VORAPAXARUM; REGISTRATION NO/DATE: EU/1/14/976/001 - EU/1/14/976/006 20150119