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Last Updated: March 18, 2024

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 nineteen 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
Tradename:VOSEVI
Applicant:Gilead Sciences Inc
Ingredient:sofosbuvir; velpatasvir; voxilaprevir
Patents:19
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209195
Generic Entry Date for 209195*:
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.

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
Patent:⤷  Try a TrialPatent Expiration:Jun 1, 2037Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Jul 30, 2034Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a TrialPatent Expiration:Dec 1, 2037Product Flag?Substance Flag?Delist Request?Y

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