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Vosevi is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are seventeen patents protecting this drug.
This drug has five hundred and seventy-two 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.
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
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||1|
|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
*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
|Partners in Health||Phase 4|
Pharmacology for VOSEVI
|Country||Patent Number||Estimated Expiration|
|Uruguay||33310||⤷ Free Forever Trial|
|China||104017020||⤷ Free Forever Trial|
|Canada||2877005||⤷ Free Forever Trial|
|Japan||5899327||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|2203462||92600||Luxembourg||⤷ Free Forever Trial||PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR 20140117|
|2203462||C 2014 043||Romania||⤷ Free Forever Trial||PRODUCT NAME: SOFOSBUVIR; NATIONAL AUTHORISATION NUMBER: EU/1/13/894(001-002); DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/894(001-002); DATE OF FIRST AUTHORISATION IN EEA: 20140116|
|2203462||2014/065||Ireland||⤷ Free Forever Trial||PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116|
|2203462||132014902310732||Italy||⤷ Free Forever Trial||PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|