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Last Updated: February 29, 2024

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

Sofosbuvir; velpatasvir has five hundred and fourteen patent family members in forty-eight countries.

Two suppliers are listed for this compound.

Summary for sofosbuvir; velpatasvir
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for sofosbuvir; velpatasvir
Generic Entry Dates for sofosbuvir; velpatasvir*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL
Generic Entry Dates for sofosbuvir; velpatasvir*:
Constraining patent/regulatory exclusivity:
Dosage:
PELLETS;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for sofosbuvir; velpatasvir

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

SponsorPhase
Peking University People's HospitalPhase 4
Macfarlane Burnet Institute for Medical Research and Public Health LtdPhase 4
The University of QueenslandPhase 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 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 PELLETS;ORAL 214187-002 Jun 10, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir PELLETS;ORAL 214187-002 Jun 10, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir PELLETS;ORAL 214187-002 Jun 10, 2021 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; 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
European Patent Office 2910562 Ester de N-[(2'r)-2'-deoxy-2'-fluoro-2'-méthyl-p-phényl-5'-uridylyl]-l-alanine-1-méthyléthyle en forme cristalline (N-[(2'r)-2'-deoxy-2 '-fluoro-2'-methyl-p-phenyl-5 '-uridylyl]-l-alanine 1-methylethyl ester in crystalline form) ⤷  Try a Trial
Portugal 2709613 ⤷  Try a Trial
Japan 2012527477 ⤷  Try a Trial
Ukraine 110354 ПРОТИВІРУСНІ СПОЛУКИ (ANTI-VIRAL COMPOUNDS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sofosbuvir; velpatasvir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 132014902310732 Italy ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117
2635588 C02635588/01 Switzerland ⤷  Try a Trial PRODUCT NAME: VELPATASVIR + SOFOSBUVIR + VOXILAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66510 08.12.2017
2203462 CR 2014 00061 Denmark ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140117
2203462 2014029 Norway ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
>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.