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Last Updated: November 21, 2024

Sofosbuvir - Generic Drug Details


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What are the generic drug 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 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.

Summary for sofosbuvir
Recent Clinical Trials for sofosbuvir

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

SponsorPhase
UNITAIDEarly Phase 1
Médecins du MondeEarly Phase 1
International Network of People who Use DrugsEarly Phase 1

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 VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc SOVALDI sofosbuvir PELLETS;ORAL 212480-001 Aug 28, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir PELLETS;ORAL 214187-002 Jun 10, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Australia 2011235112 ⤷  Sign Up
Montenegro 03009 METODE ZA LECENJE HCV-A (METHODS FOR TREATING HCV) ⤷  Sign Up
Eurasian Patent Organization 201490903 КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ВИРУСНОГО ГЕПАТИТА C ⤷  Sign Up
Philippines 12015502237 N- [ (2 ` R) -2 ` -DEOXY-2 ` -FLUORO-2 ` -METHYL-P-PHENYL-5 ` -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION ⤷  Sign Up
Taiwan 201139457 Stereoselective synthesis of phosphorus containing actives ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sofosbuvir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 67/2014 Austria ⤷  Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462 2014/065 Ireland ⤷  Sign Up PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2203462 C20140035 00135 Estonia ⤷  Sign Up PRODUCT NAME: SOFOSBUVIIR
2203462 92600 Luxembourg ⤷  Sign Up PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR 20140117
2203462 C300704 Netherlands ⤷  Sign Up 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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