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Last Updated: October 25, 2020

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Sofosbuvir - Generic Drug Details

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

Sofosbuvir is the generic ingredient in three branded drugs marketed by Gilead Sciences Inc and is included in four NDAs. There are twenty-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir has three hundred and forty-one patent family members in forty-seven countries.

There are nine drug master file entries for sofosbuvir. One supplier is listed for this compound.

Recent Clinical Trials for sofosbuvir

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

SponsorPhase
University of Witwatersrand, South AfricaPhase 2
Mansoura UniversityPhase 3
Pontificia Universidad JaverianaPhase 2/Phase 3

See all sofosbuvir clinical trials

Pharmacology for sofosbuvir
Medical Subject Heading (MeSH) Categories for sofosbuvir
Paragraph IV (Patent) Challenges for SOFOSBUVIR
Tradename Dosage Ingredient NDA Submissiondate
SOVALDI TABLET;ORAL sofosbuvir 204671 2017-12-06

US Patents and Regulatory Information for sofosbuvir

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 SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 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 SOVALDI sofosbuvir TABLET;ORAL 204671-002 Aug 28, 2019 RX Yes No   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 SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes   Start Trial   Start Trial   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 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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 C02203462/01 Switzerland   Start Trial PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
2203462 PA2014040,C2203462 Lithuania   Start Trial PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2430014 92956 Luxembourg   Start Trial PRODUCT NAME: LEDIPASVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 - HARVONI (LEDIPASVIR-SOFOSBUVIR) 20141118
2203462 C300704 Netherlands   Start Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462 1490066-6 Sweden   Start Trial PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117
2203462 67/2014 Austria   Start Trial PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462 C20140035 00135 Estonia   Start Trial PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Merck
Express Scripts

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