Details for New Drug Application (NDA): 204886

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NDA 204886 describes ZONTIVITY, which is a drug marketed by Xspire Pharma and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ZONTIVITY profile page.

The generic ingredient in ZONTIVITY is vorapaxar sulfate. One supplier is listed for this compound. Additional details are available on the vorapaxar sulfate profile page.

Summary for 204886

Tradename:	ZONTIVITY
Applicant:	Xspire Pharma
Ingredient:	vorapaxar sulfate
Patents:	2

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for 204886

Generic Entry Date for 204886^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Pharmacology for NDA: 204886

Mechanism of Action	Protease-activated Receptor-1 Antagonists

Suppliers and Packaging for NDA: 204886

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886	NDA	WraSer Pharmaceuticals, LLC	66992-208	66992-208-30	30 TABLET, FILM COATED in 1 BOTTLE (66992-208-30)
ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886	NDA	WraSer Pharmaceuticals, LLC	66992-208	66992-208-90	90 TABLET, FILM COATED in 1 BOTTLE (66992-208-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.08MG BASE
Approval Date:	May 8, 2014	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 23, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS
Patent:	⤷ Sign Up	Patent Expiration:	May 30, 2024	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS IN PATIENTS WITH A HISTORY OF MYOCARDIAL INFARCTION (MI) OR WITH PERIPHERAL ARTERIAL DISEASE (PAD)

Expired US Patents for NDA 204886

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Xspire Pharma	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

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