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Last Updated: September 28, 2021

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Details for New Drug Application (NDA): 209195

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NDA 209195 describes VOSEVI, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are seventeen patents protecting this drug. Additional details are available on the VOSEVI profile page.

The generic ingredient in VOSEVI is sofosbuvir; velpatasvir; voxilaprevir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir; velpatasvir; voxilaprevir profile page.
Summary for 209195
Applicant:Gilead Sciences Inc
Ingredient:sofosbuvir; velpatasvir; voxilaprevir
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 209195
Generic Entry Date for 209195*:
Constraining patent/regulatory exclusivity:

*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.

Suppliers and Packaging for NDA: 209195
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195 NDA Gilead Sciences, Inc. 61958-2401 61958-2401-1 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2401-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG;100MG;100MG
Approval Date:Jul 18, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 18, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Free Forever TrialPatent Expiration:Jun 1, 2037Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Sep 26, 2029Product Flag?Substance Flag?Delist Request?Y

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