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-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sofosbuvir; velpatasvir has five hundred and nineteen patent family members in forty-eight countries.
Two suppliers are listed for this compound.
Summary for SOFOSBUVIR; VELPATASVIR
International Patents: | 519 |
US Patents: | 21 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 74 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SOFOSBUVIR; VELPATASVIR |
DailyMed Link: | SOFOSBUVIR; VELPATASVIR at DailyMed |
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
Sponsor | Phase |
---|---|
Burnet Institute | Early Phase 1 |
UNITAID | Early Phase 1 |
Médecins du Monde | Early Phase 1 |
Pharmacology 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-002 | Mar 19, 2020 | RX | Yes | No | ⤷ 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 | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-002 | Mar 19, 2020 | RX | Yes | No | ⤷ 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; 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 |
---|---|---|---|
Colombia | 6930366 | Método para el tratamiento de vhc | ⤷ Sign Up |
China | 101918425 | Nucleoside phosphoramidate prodrugs | ⤷ Sign Up |
Spain | 2745462 | ⤷ Sign Up | |
Taiwan | I598358 | ⤷ Sign Up | |
Eurasian Patent Organization | 201592101 | 1-МЕТИЛЭТИЛОВЫЙ СЛОЖНЫЙ ЭФИР N-[(2'R)-2'-ДЕЗОКСИ-2'-ФТОР-2'-МЕТИЛ-Р-ФЕНИЛ-5'-УРИДИЛ]-L-АЛАНИНА И СПОСОБ ЕГО ПОЛУЧЕНИЯ | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SOFOSBUVIR; VELPATASVIR
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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