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 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 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: | 620 |
US Patents: | 19 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 3 |
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 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
Sponsor | Phase |
---|---|
Peking University People's Hospital | Phase 4 |
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-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
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 |
---|---|---|---|
European Patent Office | 2910562 | Ester de N-[(2'r)-2'-deoxy-2'-fluoro-2'-méthyl-p-phényl-5'-uridylyl]-l-alanine-1-méthyléthyle en forme cristalline (N-[(2'r)-2'-deoxy-2 '-fluoro-2'-methyl-p-phenyl-5 '-uridylyl]-l-alanine 1-methylethyl ester in crystalline form) | ⤷ Try a Trial |
Japan | 5905020 | ⤷ Try a Trial | |
China | 116731098 | 核苷氨基磷酸酯前药 | ⤷ Try a Trial |
New Zealand | 579880 | (S)-2-{ [(2R,3R,4R,5R)-5-(2,4-Dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydro-furan-2-ylmethoxy]-phenoxy-phosphorylamino} -propionic acid isopropyl ester | ⤷ Try a Trial |
Argentina | 066898 | DERIVADOS DE FOSFORAMIDATO DE NUCLEOSIDOS. PROCESOS DE OBTENCION Y COMPOSICIONES FARMACEUTICAS. | ⤷ Try a Trial |
Japan | 2015028060 | N−[(2’R)−2’−デオキシ−2’−フルオロ−2’−メチル−P−フェニル−5’−ウリジリル]−L−アラニン1−メチルエチルエステルおよびその製造のためのプロセス (N-[(2'R)-2'-DEOXY-2'-FLUORO-2'-METHYL-P-PHENYL-5'-URIDYLYL]-L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION) | ⤷ Try a Trial |
Canada | 2817840 | COMPOSES ANTIVIRAUX (ANTIVIRAL COMPOUNDS) | ⤷ 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 | C201430078 | Spain | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIR; NATIONAL AUTHORISATION NUMBER: EU/1/13/894; DATE OF AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/894; DATE OF FIRST AUTHORISATION IN EEA: 20140116 |
2203462 | 132014902310732 | Italy | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117 |
2203462 | C20140035 | Estonia | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014 |
2430014 | 2016C/006 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LEDIPASVIR/SOFOSBUVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 20141118 |
2203462 | 300704 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
2203462 | SPC/GB14/078 | United Kingdom | ⤷ Try a Trial | CORRECTION OF GRANT INFORMATION ON SUPPLEMENTARY PROTECTION CERTIFICATE APPLICATIONS APPLICANT: GILEAD PHARMASSET LLCGILEAD SCIENCES, INC., 333 LAKESIDE DRIVE, FOSTER CITY, CA 94404, USA PRODUCT: SOFOSBUVIR PRODUCT TYPE: MEDICINALAUTHORISED: UK EU/1/13/894 - 001 17 JANUARY 2014 UK EU/1/13/894 - 002 17 JANUARY 2014 AUTHORISED EXTENSION: PATENT NO: EP2203462 TITLE: NUCLEOSIDE PHOSPHORAMIDATE PRODRUGS SPC NO: SPC/GB14/078 DATE GRANTED: 7 SEPTEMBER 2020 MAXIMUM PERIOD EXPIRES ON: 16 JANUARY 2029* CORRECTION OF GRANT DETAILS IN JOURNAL NUMBER 6854 DATED 30 SEPTEMBER 2020 TO CORRECT THE GRANT DATE AND TO INCLUDE MAXIMUM EXPIRY DETAILS. |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |