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 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
Summary for VOSEVI
International Patents: | 612 |
US Patents: | 18 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 2 |
Formulation / Manufacturing: | see details |
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 |


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
Sponsor | Phase |
---|---|
Partners in Health | Phase 4 |
Gilead Sciences | Phase 3 |
Pharmacology for VOSEVI
Anatomical Therapeutic Chemical (ATC) Classes for VOSEVI
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
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 |