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Last Updated: January 30, 2023

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 four branded drugs marketed by Gilead Sciences Inc and Teva Pharms Usa Inc, and is included in six NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are nine drug master file entries for sofosbuvir.

Summary for sofosbuvir
Recent Clinical Trials for sofosbuvir

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

SponsorPhase
Peking University People's HospitalPhase 4
Tanta UniversityPhase 3
The University of QueenslandPhase 4

See all sofosbuvir clinical trials

Medical Subject Heading (MeSH) Categories for sofosbuvir
Paragraph IV (Patent) Challenges for SOFOSBUVIR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SOVALDI Tablets sofosbuvir 400 mg 204671 2 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 EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc SOVALDI sofosbuvir PELLETS;ORAL 212480-002 Aug 28, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for sofosbuvir

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gilead Sciences Ireland UC Sovaldi sofosbuvir EMEA/H/C/002798
Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1)., , For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1., , Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1)., , For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.,
Authorised no no no 2014-01-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for sofosbuvir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 132014902310732 Italy See Plans and Pricing PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117
2203462 PA2014040,C2203462 Lithuania See Plans and Pricing PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462 PA2014040 Lithuania See Plans and Pricing PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462 2014029 Norway See Plans and Pricing PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
2203462 CR 2014 00061 Denmark See Plans and Pricing PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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