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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 two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sofosbuvir; velpatasvir has four hundred and fifty-two patent family members in forty-seven countries.
There are nine drug master file entries for sofosbuvir; velpatasvir. Two suppliers are listed for this compound.
Summary for sofosbuvir; velpatasvir
International Patents: | 452 |
US Patents: | 17 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 9 |
Suppliers / Packagers: | 2 |
Clinical Trials: | 56 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sofosbuvir; velpatasvir |
DailyMed Link: | sofosbuvir; velpatasvir at DailyMed |
Recent Clinical Trials for sofosbuvir; velpatasvir
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 4 |
University of Kentucky | Phase 4 |
National Institute on Drug Abuse (NIDA) | Phase 4 |
Recent Litigation for sofosbuvir; velpatasvir
Identify potential future generic entrants
District Court Litigation
Case Name | Date |
---|---|
Gilead Sciences, Inc. v. Teva Pharmaceuticals USA, Inc. | 2018-03-27 |
GILEAD SCIENCES, INC. v. NATCO PHARMA LIMITED | 2018-03-14 |
Idenix Pharmaceuticals LLC v. Gilead Sciences, Inc. | 2014-07-01 |
See all sofosbuvir; velpatasvir litigation
PTAB Litigation
Petitioner | Date |
---|---|
Initiative for Medicines, Access & Knowledge (I-MAK), Inc. | 2017-12-26 |
Initiative for Medicines, Access & Knowledge (I-MAK), Inc. | 2017-11-09 |
Initiative for Medicines, Access & Knowledge (I-MAK), Inc. | 2017-11-02 |
Pharmacology for sofosbuvir; velpatasvir
Country | Patent Number | Estimated Expiration |
---|---|---|
Peru | 01832013 | Start Trial |
Chile | 2014000630 | Start Trial |
Lithuania | 2432792 | Start Trial |
Argentina | 080819 | Start Trial |
Mexico | 2012011324 | Start Trial |
Canada | 2840242 | Start Trial |
San Marino | T201500197 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for sofosbuvir; velpatasvir
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2203462 | 92600 | Luxembourg | Start Trial | PRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117 |
2203462 | 67/2014 | Austria | Start Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117 |
2203462 | C20140035 00135 | Estonia | Start Trial | PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014 |
2203462 | C300704 | Netherlands | Start Trial | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
2203462 | CA 2014 00061 | Denmark | Start Trial | PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116 |
2203462 | 122014000108 | Germany | Start Trial | PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116 |
2203462 | 300704 | Netherlands | Start Trial | PRODUCT NAME: 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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