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EPCLUSA Drug Profile
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» See Plans and PricingWhich 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 sixty-eight 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.
US ANDA Litigation and 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: | 468 |
| US Patents: | 22 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 23 |
| 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 |
|---|---|
| Catherine Chappell | Phase 1 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 1 |
| Gilead Sciences | Phase 1 |
Pharmacology for EPCLUSA
US Patents and Regulatory Information for EPCLUSA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for EPCLUSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013040492 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2010135569 | Start Trial |
| New Zealand | 709926 | Start Trial |
| Philippines | 12014501133 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EPCLUSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 132014902310732 | Italy | Start Trial | PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117 |
| 2203462 | 214 5029-2014 | Slovakia | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
