DrugPatentWatch Database Preview
EPCLUSA Drug Profile
When do Epclusa patents expire, and when can generic versions of Epclusa launch?
Epclusa is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are fourteen patents protecting this drug.
This drug has four hundred and fifty-two patent family members in forty-seven countries.
The generic ingredient in EPCLUSA is sofosbuvir; velpatasvir. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sofosbuvir; velpatasvir profile page.
Summary for EPCLUSA
| International Patents: | 452 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 22 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EPCLUSA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPCLUSA |
| DailyMed Link: | EPCLUSA at DailyMed |
Generic Entry Opportunity Date for EPCLUSA
Generic Entry Date for EPCLUSA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 EPCLUSA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2 |
| University of Pennsylvania | Phase 2 |
| State Secretary of Health of Rio Grande do Sul | N/A |
Recent Litigation for EPCLUSA
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 |
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 EPCLUSA
Synonyms for EPCLUSA
| Epclusa Tablet |
| S900007160 |
| Sofosbuvir / velpatasvir |
| Sofosbuvir and velpatasvir |
| Sofosbuvir mixture with velpatasvir |
| Velpatasvir / Sofosbuvir |
US Patents and Regulatory Information for EPCLUSA
International Patents for EPCLUSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2014532657 | Start Trial |
| Moldova, Republic of | 20140035 | Start Trial |
| Peru | 14442017 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2013040492 | Start Trial |
| Taiwan | 201511756 | Start Trial |
| New Zealand | 716840 | Start Trial |
| South Korea | 20180026563 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EPCLUSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2203462 | CA 2014 00061 | Denmark | Start Trial | PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116 |
| 2203462 | PA2014040 | Lithuania | Start Trial | PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 |
| 2203462 | 300704 | Netherlands | Start Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| 2203462 | C02203462/01 | Switzerland | Start Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014 |
| 2203462 | 2014029 | Norway | Start Trial | PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117 |
| 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 | C20140035 00135 | Estonia | Start Trial | PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
