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Last Updated: February 19, 2020

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Sofosbuvir; velpatasvir - Generic Drug Details

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What are the generic drug sources for sofosbuvir; velpatasvir and what is the scope of freedom to operate?

Sofosbuvir; velpatasvir is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc and is included in two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir; velpatasvir has four hundred and sixty-two patent family members in forty-seven countries.

There are nine drug master file entries for sofosbuvir; velpatasvir. Two suppliers are listed for this compound.

Summary for sofosbuvir; velpatasvir
Recent Clinical Trials for sofosbuvir; velpatasvir

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SponsorPhase
University of BristolPhase 4
National Cancer Institute (NCI)Phase 4
University of KentuckyPhase 4

See all sofosbuvir; velpatasvir clinical trials

Recent Litigation for sofosbuvir; velpatasvir

Identify potential future generic entrants

District Court Litigation
Case NameDate
Gilead Sciences, Inc. v. Teva Pharmaceuticals USA, Inc.2018-03-27
GILEAD SCIENCES, INC. v. NATCO PHARMA LIMITED2018-03-14
Idenix Pharmaceuticals LLC v. Gilead Sciences, Inc.2014-07-01

See all sofosbuvir; velpatasvir litigation

PTAB Litigation
PetitionerDate
2017-12-26
2017-11-09
2017-11-02

See all sofosbuvir; velpatasvir litigation

US Patents and Regulatory Information for sofosbuvir; velpatasvir

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 EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for sofosbuvir; velpatasvir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 92600 Luxembourg   Start Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117
2203462 2014/065 Ireland   Start Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2203462 C02203462/01 Switzerland   Start Trial PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
2203462 PA2014040 Lithuania   Start Trial PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462 CR 2014 00061 Denmark   Start Trial PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140117
2203462 67/2014 Austria   Start Trial PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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