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 Xspire Pharma 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
Ken Mahaffey	Phase 2
Merck Sharp & Dohme Corp.	Phase 2
Matthew Mell	Phase 2

See all vorapaxar sulfate clinical trials

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
Xspire Pharma	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014		RX	Yes	Yes			Y	Y
Xspire Pharma	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
Xspire Pharma	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014

International Patents for vorapaxar sulfate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1294714	ANTAGONISTES DU RECEPTEUR DE LA THROMBINE (THROMBIN RECEPTOR ANTAGONISTS)
Cyprus	1111363
Canada	2482858	ANTAGONISTES TRICYCLIQUES DU RECEPTEUR DE THROMBINE (TRICYCLIC THROMBIN RECEPTOR ANTAGONISTS)
Spain	2357876
Malaysia	143834	THROMBIN RECEPTOR ANTAGONISTS
Portugal	1495018
Mexico	PA04010308	ANTAGONISTAS DEL RECEPTOR DE TROMBINA TRICICLICO. (TRICYCLIC THROMBIN RECEPTOR ANTAGONISTS.)

Supplementary Protection Certificates for vorapaxar sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1495018	C300746	Netherlands		PRODUCT NAME: VORAPAXAR IN ELKE DOOR HET; REGISTRATION NO/DATE: EU/1/14/976/001-006 20150119
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	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	2015C/037	Belgium		PRODUCT NAME: VORAPAXAR, OU SON SEL OU SOLVAT PHARMACOLOGIQUEMENT ADMISSIBLE; AUTHORISATION NUMBER AND DATE: EU/1/14/976/001
1495018	218 50011-2015	Slovakia		PRODUCT NAME: VORAPAXARIUMSULFAT; REGISTRATION NO/DATE: EU/1/14/976/001 - EU/1/14/976/006 20150121
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