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Last Updated: April 15, 2024

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VOSEVI Drug Patent Profile


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Which patents cover Vosevi, and what generic alternatives are available?

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

This drug has six hundred and twenty 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 twenty-one US patents.

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

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Combination formulation of two antiviral compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Combination formulation of three antiviral compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Antiviral compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Nucleoside phosphoramidates
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Nucleoside phosphoramidates
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compositions and methods for treating hepatitis C virus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Antiviral compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Antiviral compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Nucleoside phosphoramidates
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Inhibitors of hepatitis C virus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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: ⤷  Try a Trial

Australia

Patent: 17273851
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2017011025
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 25380
Estimated Expiration: ⤷  Try a Trial

China

Patent: 9310678
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 1892376
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 63346
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 3155
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 19517492
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 18014790
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 142
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201810189S
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 190014536
Patent: 3종의 항바이러스 화합물의 조합 제제
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 1818932
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 261
Estimated Expiration: ⤷  Try a Trial

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
Spain 2492470 ⤷  Try a Trial
Poland 2432792 ⤷  Try a Trial
Japan 2018039851 抗ウイルス化合物 (ANTIVIRAL COMPOUND) ⤷  Try a Trial
European Patent Office 3321275 FORME CRYSTALLINE DE SOFOSBUVIR (CRYSTALLINE FORM OF SOFOSBUVIR) ⤷  Try a Trial
Poland 2552930 ⤷  Try a Trial
Spain 2843023 ⤷  Try a Trial
Brazil 122021012378 Uso de inibidores do vírus da hepatite c ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VOSEVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 C02203462/01 Switzerland ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
2203462 2014029 Norway ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
2203462 1491066-5 Sweden ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIR; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/13/894, 2014-01-17
2203462 C20140035 Estonia ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2203462 1490066-6 Sweden ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIR
2203462 SPC/GB14/078 United Kingdom ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIR; REGISTERED: UK EU/1/13/894/001 20140117; UK EU/1/13/894/002 20140117
2203462 PA2014040,C2203462 Lithuania ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIRAS; 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

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

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.