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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 201917

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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
Formulation / Manufacturing:	see details

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

Generic Entry Date for 201917^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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:	⤷ Try a Trial	Patent Expiration:	Feb 25, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Try a Trial	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vertex Pharms	INCIVEK	telaprevir	TABLET;ORAL	201917-001	May 23, 2011	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Summary for 201917

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

Profile for product number 001

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