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Last Updated: June 21, 2024

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VOSEVI Drug Patent Profile


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Which patents cover Vosevi, and when can generic versions of Vosevi launch?

Vosevi is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are eighteen patents protecting this drug.

This drug has six hundred and twenty-two patent family members in forty-nine countries.

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.

DrugPatentWatch® Generic Entry Outlook for Vosevi

Vosevi was eligible for patent challenges on June 28, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 1, 2037. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for VOSEVI
Drug Prices for VOSEVI

See drug prices for VOSEVI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VOSEVI
Generic Entry Date for VOSEVI*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for VOSEVI

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Peking University People's HospitalPhase 4
Partners in HealthPhase 4
Gilead SciencesPhase 3

See all VOSEVI clinical trials

US Patents and Regulatory Information for VOSEVI

VOSEVI is protected by nineteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VOSEVI is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VOSEVI

Combination formulation of three antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Combination formulation of two antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Combination formulation of three antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidates
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidates
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions and methods for treating hepatitis C virus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidates
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Inhibitors of hepatitis C virus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for VOSEVI

When does loss-of-exclusivity occur for VOSEVI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 8616
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 17273851
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2017011025
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 25380
Estimated Expiration: ⤷  Sign Up

China

Patent: 9310678
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1892376
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 63346
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 3155
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 19517492
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 18014790
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 142
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201810189S
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 190014536
Patent: 3종의 항바이러스 화합물의 조합 제제
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 1818932
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 261
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VOSEVI around the world.

Country Patent Number Title Estimated Expiration
Portugal 2609923 ⤷  Sign Up
Slovenia 2432792 ⤷  Sign Up
New Zealand 720391 Methods for treating hcv ⤷  Sign Up
Uruguay 33311 FOSFORAMIDATOS DE NUCLEOSIDOS ⤷  Sign Up
New Zealand 739248 Inhibitors of hepatitis c virus ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VOSEVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 SPC/GB14/078 United Kingdom ⤷  Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTERED: UK EU/1/13/894/001 20140117; UK EU/1/13/894/002 20140117
2203462 67/2014 Austria ⤷  Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462 CR 2014 00061 Denmark ⤷  Sign Up PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140117
2203462 92600 Luxembourg ⤷  Sign Up PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR 20140117
2203462 PA2014040 Lithuania ⤷  Sign Up PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.