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Last Updated: October 31, 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 eighteen 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:18
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:⤷  Sign UpPatent Expiration:Jun 1, 2037Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jul 30, 2034Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Dec 1, 2037Product Flag?Substance Flag?Delist Request?Y

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.