Details for New Drug Application (NDA): 204886

NDA 204886 describes ZONTIVITY, which is a drug marketed by Key Therap and is included in one NDA. There is one patent protecting this drug. Additional details are available on the ZONTIVITY profile page.

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

Summary for 204886

Tradename:	ZONTIVITY
Applicant:	Key Therap
Ingredient:	vorapaxar sulfate
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 204886

Constraining patent/regulatory exclusivity:

7,304,078

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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2.08MG BASE
Approval Date:	May 8, 2014	TE:		RLD:	Yes
Patent:	7,304,078	Patent Expiration:	Dec 23, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS

Expired US Patents for NDA 204886

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

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