Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
AstraZeneca
Express Scripts
Harvard Business School
McKinsey

Last Updated: May 20, 2022

VOSEVI Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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 twelve patent family members in forty-eight 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 June 1, 2037. This may change due to patent challenges or generic licensing.

There have been five 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

< Available with Subscription >

  Sign up for a Free Trial

Drug patent expirations by year for VOSEVI
Drug Prices for VOSEVI

See drug prices for VOSEVI

DrugPatentWatch® Estimated Generic Entry Opportunity 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
Partners in HealthPhase 4
Gilead SciencesPhase 3

See all VOSEVI clinical trials

US Patents and Regulatory Information for VOSEVI

VOSEVI is protected by twenty US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VOSEVI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination formulation of two antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treating hepatitis C virus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhibitors of hepatitis C virus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting VOSEVI

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 17273851
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2017011025
Estimated Expiration: See Plans and Pricing

Canada

Patent: 25380
Estimated Expiration: See Plans and Pricing

China

Patent: 9310678
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1892376
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 63346
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3155
Estimated Expiration: See Plans and Pricing

Japan

Patent: 19517492
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 18014790
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 142
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201810189S
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 190014536
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1818932
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 261
Estimated Expiration: See Plans and Pricing

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
European Patent Office 3463346 FORMULATION COMBINÉE DE TROIS COMPOSÉS ANTIVIRAUX (COMBINATION FORMULATION OF THREE ANTIVIRAL COMPOUNDS) See Plans and Pricing
New Zealand 703064 Inhibitors of hepatitis c virus See Plans and Pricing
European Patent Office 3699176 COMPOSÉS ANTIVIRAUX (ANTIVIRAL COMPOUNDS) See Plans and Pricing
Japan 2018154651 C型肝炎ウイルスの阻害剤 (HEPATITIS C VIRUS INHIBITOR) See Plans and Pricing
Japan 2014533733 C型肝炎ウイルスを処置するための組成物および方法 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VOSEVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 14C0082 France See Plans and Pricing PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462 122014000108 Germany See Plans and Pricing PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2203462 C20140035 Estonia See Plans and Pricing PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2203462 C20140035 00135 Estonia See Plans and Pricing PRODUCT NAME: SOFOSBUVIIR
2203462 67/2014 Austria See Plans and Pricing PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Boehringer Ingelheim
Mallinckrodt
AstraZeneca
Express Scripts

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.