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.
One supplier is listed for this compound.
Summary for sofosbuvir; velpatasvir
International Patents: | 519 |
US Patents: | 21 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
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 |
---|---|
Médecins du Monde | Early Phase 1 |
International Network of People who Use Drugs | Early Phase 1 |
University of Bristol | Early Phase 1 |
Pharmacology 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 |
---|---|---|---|
Taiwan | 201318627 | Methods and compositions for treating hepatitis C virus | ⤷ Try for Free |
Singapore | 10201509456S | ANTIVIRAL COMPOUNDS | ⤷ Try for Free |
San Marino | T201600316 | E PROCEDIMENTO PER LA PREPARAZIONE DELL'ESTERE 1-METILETILICO DI N-[(2'R)- 2'-DEOSSI-2'-FLUORO-2'-METIL-P-FENIL-5'- URIDILlL]-L-ALANINA | ⤷ Try for Free |
South Korea | 101525293 | ⤷ Try for Free | |
Brazil | 122013004621 | fosforamidatos de nucleosídeo, seus processos de preparação, sua composição e seu uso | ⤷ Try for Free |
Japan | 2015028060 | N−[(2’R)−2’−デオキシ−2’−フルオロ−2’−メチル−P−フェニル−5’−ウリジリル]−L−アラニン1−メチルエチルエステルおよびその製造のためのプロセス (N-[(2'R)-2'-DEOXY-2'-FLUORO-2'-METHYL-P-PHENYL-5'-URIDYLYL]-L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION) | ⤷ Try for Free |
>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 for Free | PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117 |
2203462 | 122014000108 | Germany | ⤷ Try for Free | PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116 |
2203462 | C20140035 00135 | Estonia | ⤷ Try for Free | PRODUCT NAME: SOFOSBUVIIR |
2203462 | C300704 | Netherlands | ⤷ Try for Free | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
2203462 | C 2014 043 | Romania | ⤷ Try for Free | PRODUCT NAME: SOFOSBUVIR; NATIONAL AUTHORISATION NUMBER: EU/1/13/894(001-002); DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/894(001-002); DATE OF FIRST AUTHORISATION IN EEA: 20140116 |
2203462 | 92600 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR 20140117 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory of Sofosbuvir and Velpatasvir
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