DrugPatentWatch Database Preview
EPCLUSA Drug Profile
» See Plans and Pricing
Which patents cover Epclusa, 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 twenty-two patents protecting this drug.
This drug has four hundred and ninety 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. One supplier is listed for this compound. Additional details are available on the sofosbuvir; velpatasvir profile page.
DrugPatentWatch® Generic Entry Outlook for Epclusa
Epclusa was eligible for patent challenges on June 28, 2020.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 30, 2034. This may change due to patent challenges or generic licensing.
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for EPCLUSA
| International Patents: | 490 |
| US Patents: | 22 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 25 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EPCLUSA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPCLUSA |
| What excipients (inactive ingredients) are in EPCLUSA? | EPCLUSA excipients list |
| DailyMed Link: | EPCLUSA at DailyMed |
DrugPatentWatch® Estimated 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 |
|---|---|
| Mansoura University | Phase 3 |
| Gilead Sciences | Phase 1 |
| Catherine Chappell | Phase 1 |
Pharmacology for EPCLUSA
US Patents and Regulatory Information for EPCLUSA
International Patents for EPCLUSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1213572 | Start Trial |
| Denmark | 2609923 | Start Trial |
| Poland | 2552930 | Start Trial |
| Colombia | 6791562 | Start Trial |
| European Patent Office | 2432792 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2008121634 | Start Trial |
| South Korea | 101991298 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EPCLUSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2203462 | CR 2014 00061 | Denmark | Start Trial | PRODUCT NAME: SOFOSBUVIR; REG. 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 | 214 5029-2014 | Slovakia | Start Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117 |
| 2203462 | 67/2014 | Austria | Start Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117 |
| 2203462 | PA2014040,C2203462 | Lithuania | Start Trial | PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 |
| 2635588 | C02635588/01 | Switzerland | Start Trial | PRODUCT NAME: VELPATASVIR + SOFOSBUVIR + VOXILAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66510 08.12.2017 |
| 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 |
