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Sofosbuvir; velpatasvir - Generic Drug Details
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 sixty-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: | 462 |
| US Patents: | 17 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 9 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 57 |
| 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 |
|---|---|
| University of Bristol | Phase 4 |
| National Cancer Institute (NCI) | Phase 4 |
| University of Kentucky | 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 |
|---|---|
| 2017-12-26 | |
| 2017-11-09 | |
| 2017-11-02 |
Pharmacology for sofosbuvir; velpatasvir
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Peru | 20130183 | Start Trial |
| South Korea | 20150008929 | Start Trial |
| Poland | 2709613 | Start Trial |
| San Marino | T201500285 | Start Trial |
| Australia | 2012332827 | Start Trial |
| Japan | 2012527477 | 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 | 2014/065 | Ireland | Start Trial | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116 |
| 2203462 | C02203462/01 | Switzerland | Start Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014 |
| 2203462 | PA2014040 | Lithuania | Start Trial | PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 |
| 2203462 | CR 2014 00061 | Denmark | Start Trial | PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140117 |
| 2203462 | 67/2014 | Austria | Start Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 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 verifification 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.
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