EPCLUSA Drug Patent Profile

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 two NDAs. There are fifteen patents protecting this drug.

This drug has five hundred and ten 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 July 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:	510
US Patents:	15
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	39
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

See drug prices for EPCLUSA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for EPCLUSA

NDA:

208341

Dosage:

TABLET;ORAL

NDA:

214187

Dosage:

PELLETS;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
Cairns Hinterland Health Hospital and Health Services	Phase 4
Macfarlane Burnet Institute for Medical Research and Public Health Ltd	Phase 4
The University of Queensland	Phase 4

See all EPCLUSA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for EPCLUSA

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for EPCLUSA

EPCLUSA is protected by fifteen US patents and eleven FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting EPCLUSA

FDA Regulatory Exclusivity protecting 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
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No

International Patents for EPCLUSA

When does loss-of-exclusivity occur for EPCLUSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Canada

China

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Poland

Portugal

Singapore

Slovenia

South Korea

Spain

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EPCLUSA around the world.

Country	Patent Number	Title	Estimated Expiration
China	104039319	Compositions and methods for treating hepatitis c virus
European Patent Office	3778606	IMIDAZOLYLIMIDAZOLES CONDENSÉS EN TANT QUE COMPOSÉS ANTIVIRAUX (CONDENSED IMIDAZOLYLIMIDAZOLES AS ANTIVIRAL COMPOUNDS)
European Patent Office	2801580	Promédicaments de phosphoramidate de nucléoside (Nucleoside phosphoramidate prodrugs)
Mexico	2014003145	METODOS PARA EL TRATAMIENTO DE VHC. (METHODS FOR TREATING HCV.)
European Patent Office	2752422	Synthèse stéréosélective d'agents actifs contenant du phosphore (Stereoselective synthesis of phosphorus containing actives)
European Patent Office	2552930	(S)-ISOPROPYL 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-DIOXO-3,4-DIHYDROPYRIMIDIN-1-(2H)-YL)-4-FLUORO-3-HYDROXY-4-METHYLTETRAHYDROFURAN-2-YL)METHOXY)(PHENOXY)PHOSPHORYL)AMINO)PROPANOATE CRISTALLIN (CRYSTALLINE (S)-ISOPROPYL 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-DIOXO-3,4-DIHYDROPYRIMIDIN-1-(2H)-YL)-4-FLUORO-3-HYDROXY-4-METHYLTETRAHYDROFURAN-2-YL)METHOXY)(PHENOXY)PHOSPHORYL)AMINO)PROPANOATE)
Denmark	2635588

Supplementary Protection Certificates for EPCLUSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	C02203462/01	Switzerland		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
2203462	2014/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2203462	1490066-6	Sweden		PRODUCT NAME: SOFOSBUVIR
2203462	122014000108	Germany		PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2203462	132014902310732	Italy		PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117
2203462	2014029	Norway		PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
2203462	67/2014	Austria		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117