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Generated: October 21, 2018

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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 three 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:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 201917
Generic Entry Date for 201917*:
Constraining patent/regulatory exclusivity:
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:DISCNDosage:TABLET;ORALStrength375MG
Approval Date:May 23, 2011TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Feb 25, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:May 30, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING CHRONIC HEPATITIS C
Patent:➤ Sign UpPatent Expiration:Aug 31, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING CHRONIC HEPATITIS C

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