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Last Updated: January 18, 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 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-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

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

SponsorPhase
Jennifer HavensPhase 4
Icahn School of Medicine at Mount SinaiPhase 4
University of BristolPhase 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
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.2017-12-26
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.2017-11-09
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.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   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 EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes   Start Trial   Start Trial   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 PA2014040,C2203462 Lithuania   Start Trial PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
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 PA2014040 Lithuania   Start Trial PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2635588 C02635588/01 Switzerland   Start Trial PRODUCT NAME: VELPATASVIR + SOFOSBUVIR + VOXILAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66510 08.12.2017
2203462 CA 2014 00061 Denmark   Start Trial PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
2203462 214 5029-2014 Slovakia   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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Serving leading biopharmaceutical companies globally:

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Baxter
Harvard Business School
Boehringer Ingelheim
Johnson and Johnson
Moodys

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