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Last Updated: April 5, 2020

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Sofosbuvir; velpatasvir - Generic Drug Details

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What are the generic sources for sofosbuvir; velpatasvir and what is the scope of patent protection?

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-five 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of KentuckyPhase 4
National Institute on Drug Abuse (NIDA)Phase 4
Jennifer HavensPhase 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 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 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 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
>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 14C0082 France   Start Trial PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462 122014000108 Germany   Start Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2203462 C20140035 00135 Estonia   Start Trial PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2203462 92600 Luxembourg   Start Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117
2203462 2014029 Norway   Start Trial PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
McKinsey
AstraZeneca
Medtronic
Baxter

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