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Last Updated: April 24, 2024

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-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir has three hundred and sixty-two patent family members in forty-eight 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
M.D. Anderson Cancer CenterPhase 4
Peking University People's HospitalPhase 4
Tanta UniversityPhase 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 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 PELLETS;ORAL 214187-001 Jun 10, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

International Patents for sofosbuvir

Country Patent Number Title Estimated Expiration
Colombia 6970603 Composiciones y métodos para tratar el virus de la hepatitis c ⤷  Try a Trial
Portugal 3290428 ⤷  Try a Trial
Taiwan 201318627 Methods and compositions for treating hepatitis C virus ⤷  Try a Trial
Canada 2763151 ESTER DE N-[(2 ' R) -2' -DESOXY-2' -FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL]-L-ALANINE 1-METHYLETHYLE ET SON PROCEDE DE PRODUCTION (N- [(2'R) -2'-DEOXY-2'-FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION) ⤷  Try a Trial
China 106166160 用于治疗HCV的组合物 (Composition for treating HCV) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sofosbuvir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 PA2014040,C2203462 Lithuania ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462 14C0082 France ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462 122014000108 Germany ⤷  Try a Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2203462 C20140035 Estonia ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2203462 C300704 Netherlands ⤷  Try a Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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