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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim

Last Updated: May 11, 2021

DrugPatentWatch Database Preview

Sofosbuvir - Generic Drug Details

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What are the generic drug sources for sofosbuvir and what is the scope of patent protection?

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

Sofosbuvir has three hundred and forty-four 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

University of Witwatersrand, South AfricaPhase 2
Alexandria UniversityPhase 4
Mansoura 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 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 EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
>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 PA2014040 Lithuania   Get Started for $10 PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462 14C0082 France   Get Started for $10 PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462 C300704 Netherlands   Get Started for $10 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Express Scripts
Johnson and Johnson

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