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Last Updated: July 2, 2022

Sofosbuvir; velpatasvir - Generic Drug Details


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

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

Sofosbuvir; velpatasvir has five hundred and thirteen patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for sofosbuvir; velpatasvir
Recent Clinical Trials for sofosbuvir; velpatasvir

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

SponsorPhase
Macfarlane Burnet Institute for Medical Research and Public Health LtdPhase 4
The University of QueenslandPhase 4
Cairns Hinterland Health Hospital and Health ServicesPhase 4

See all sofosbuvir; velpatasvir clinical trials

US Patents and Regulatory Information for sofosbuvir; velpatasvir

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 See Plans and Pricing See Plans and Pricing 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 Y 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; velpatasvir

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gilead Sciences Ireland UC Epclusa sofosbuvir, velpatasvir EMEA/H/C/004210
Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).
Authorised no no no 2016-07-06
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for sofosbuvir; velpatasvir

Country Patent Number Title Estimated Expiration
Uruguay 33735 COMPUESTOS ANTIVIRALES See Plans and Pricing
Serbia 54368 KRISTALNI (S)-IZOPROPIL 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-DIOKSO-3,4-DIHIDROPIRIMIDIN-1-(2H)-IL)-4-FLUORO-3-HIDROKSI-4-METILTETRAHIDROFURAN-2-IL)METOKSI)(FENOKSI)FOSFORIL)AMINO)PROPANOAT (CRYSTALLINE (S)-ISOPROPYL 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-DIOXO-3,4-DIHYDROPYRIMIDIN-1-(2H)-YL)-4-FLUORO-3-HYDROXY-4-METHYLTETRAHYDROFURAN-2-YL)METHOXY)(PHENOXY)PHOSPHORYL)AMINO)PROPANOATE) See Plans and Pricing
Japan 2016023187 ヌクレオシドホスホロアミデートプロドラッグ (NUCLEOSIDE PHOSPHORAMIDATE PRODRUGS) See Plans and Pricing
Costa Rica 20140177 MÉTODOS PARA EL TRATAMIENTO DE VHC See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sofosbuvir; velpatasvir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 PA2014040,C2203462 Lithuania See Plans and Pricing PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2430014 2016C/006 Belgium See Plans and Pricing PRODUCT NAME: LEDIPASVIR/SOFOSBUVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 20141118
2203462 PA2014040 Lithuania See Plans and Pricing PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.