~ Buy the VOSEVI (sofosbuvir; velpatasvir; voxilaprevir) Drug Profile, 2024 PDF Report in the Report Store ~

VOSEVI Drug Patent Profile

✉ Email this page to a colleague

When do Vosevi patents expire, and what generic alternatives are available?

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

< Available with Subscription >

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for VOSEVI?
What are the global sales for VOSEVI?
What is Average Wholesale Price for VOSEVI?

Summary for VOSEVI

International Patents:	622
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Drug Prices:	Drug price information for VOSEVI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VOSEVI
What excipients (inactive ingredients) are in VOSEVI?	VOSEVI excipients list
DailyMed Link:	VOSEVI at DailyMed

Drug patent expirations by year for VOSEVI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VOSEVI

Generic Entry Date for VOSEVI^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 209195 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

Sponsor	Phase
Peking University People's Hospital	Phase 4
Partners in Health	Phase 4
Gilead Sciences	Phase 3

See all VOSEVI clinical trials

Pharmacology for VOSEVI

Drug Class	Hepatitis C Virus NS3/4A Protease Inhibitor Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors HCV NS3/4A Protease Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Organic Anion Transporting Polypeptide 2B1 Inhibitors P-Glycoprotein Inhibitors RNA Replicase Inhibitors

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

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 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

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
>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
Patent: FORMULACIÓN COMBINADA DE TRES COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 17273851
Patent: Combination formulation of three antiviral compounds
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2017011025
Patent: formulação de combinação de três compostos antivirais
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 25380
Patent: FORMULATION COMBINEE DE TROIS COMPOSES ANTIVIRAUX (COMBINATION FORMULATION OF THREE ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷ Sign Up

China

Patent: 9310678
Patent: 三种抗病毒化合物的组合制剂 (Combination formulation of three antiviral compounds)
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 1892376
Patent: КОМБИНИРОВАННЫЙ СОСТАВ ТРЕХ ПРОТИВОВИРУСНЫХ СОЕДИНЕНИЙ
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 63346
Patent: FORMULATION COMBINÉE DE TROIS COMPOSÉS ANTIVIRAUX (COMBINATION FORMULATION OF THREE ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 3155
Patent: פורמולציה משולבת של שלוש תרכובות אנטי-ויראליות (Combination formulation of three antiviral compounds)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 19517492
Patent: ３種の抗ウイルス化合物の組み合わせ製剤
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 18014790
Patent: FORMULACION COMBINADA DE TRES COMPUESTOS ANTIVIRALES. (COMBINATION FORMULATION OF THREE ANTIVIRAL COMPOUNDS.)
Estimated Expiration: ⤷ Sign Up

Morocco

Patent: 142
Patent: FORMULATION COMBINÉE DE TROIS COMPOSÉS ANTIVIRAUX
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 201810189S
Patent: COMBINATION FORMULATION OF THREE ANTIVIRAL COMPOUNDS
Estimated Expiration: ⤷ Sign Up

South Korea

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

Taiwan

Patent: 1818932
Patent: Combination formulation of three antiviral compounds
Estimated Expiration: ⤷ Sign Up

Uruguay

Patent: 261
Patent: FORMULACIÓN COMBINADA DE TRES COMPUESTOS ANTIVIRALES
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.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Mexico	336580	METODOS PARA EL TRATAMIENTO DE VHC. (METHODS FOR TREATING HCV.)	⤷ Sign Up
Poland	3290428		⤷ Sign Up
Japan	5899327		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VOSEVI

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	132014902310732	Italy	⤷ Sign Up	PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117
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
2635588	C02635588/01	Switzerland	⤷ Sign Up	PRODUCT NAME: VELPATASVIR + SOFOSBUVIR + VOXILAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66510 08.12.2017
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

AI Research Assistant

Questions you can ask:

Summary for VOSEVI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VOSEVI

Recent Clinical Trials for VOSEVI

Pharmacology for VOSEVI

Patents protecting VOSEVI

When does loss-of-exclusivity occur for VOSEVI?

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VOSEVI