Details for New Drug Application (NDA): 201917

NDA 201917 describes INCIVEK, which is a drug marketed by Vertex Pharms and is included in one NDA. There are two patents protecting this drug. Additional details are available on the INCIVEK profile page.

The generic ingredient in INCIVEK is telaprevir. There are three drug master file entries for this compound. Additional details are available on the telaprevir profile page.

Summary for 201917

Tradename:	INCIVEK
Applicant:	Vertex Pharms
Ingredient:	telaprevir
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 201917

Constraining patent/regulatory exclusivity:

8,431,615

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	375MG
Approval Date:	May 23, 2011	TE:		RLD:	No
Patent:	7,820,671	Patent Expiration:	Feb 25, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	8,431,615	Patent Expiration:	May 30, 2028	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING CHRONIC HEPATITIS C

Expired US Patents for NDA 201917

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vertex Pharms	INCIVEK	telaprevir	TABLET;ORAL	201917-001	May 23, 2011	7,820,671
Vertex Pharms	INCIVEK	telaprevir	TABLET;ORAL	201917-001	May 23, 2011	8,529,882

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