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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 sixteen patents protecting this drug.

This drug has five hundred and nineteen patent family members in forty-eight 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.

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 three 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:	519
US Patents:	16
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	40
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 Loss of Exclusivity (LOE) 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
Peking University People's Hospital	Phase 4
The University of Queensland	Phase 4
Cairns Hinterland Health Hospital and Health Services	Phase 4

See all EPCLUSA clinical trials

Pharmacology for EPCLUSA

Drug Class	Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Organic Anion Transporting Polypeptide 2B1 Inhibitors P-Glycoprotein Inhibitors RNA Replicase Inhibitors

US Patents and Regulatory Information for EPCLUSA

EPCLUSA is protected by sixteen US patents and seven 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	PELLETS;ORAL	214187-002	Jun 10, 2021		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	208341-001	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

EU/EMA Drug Approvals for EPCLUSA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Epclusa	sofosbuvir, velpatasvir	EMEA/H/C/004210 Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).	Authorised	no	no	no	2016-07-06

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

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
Japan	2017057230	ＨＣＶを処置するための方法 (METHOD FOR TREATING HCV)
Eurasian Patent Organization	023644	ПРОТИВОВИРУСНЫЕ СОЕДИНЕНИЯ (ANTIVIRAL COMPOUNDS)
Japan	2016023187	ヌクレオシドホスホロアミデートプロドラッグ (NUCLEOSIDE PHOSPHORAMIDATE PRODRUGS)
Eurasian Patent Organization	026667	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ЛЕЧЕНИЯ ВИРУСА ГЕПАТИТА С (PHARMACEUTICAL COMPOSITION FOR TREATING HEPATITIS C VIRUS)
Poland	2203462
Hong Kong	1251578	含結晶(S)-異丙基 2-(((S)-(((2R，3R，4R，5R)-5-(2，4-二氧代-3，4-二氫嘧啶-1(2H)-基)-4-氟-3-羥基-4-甲基四氫呋喃-2-基)甲氧基)(苯氧基)磷酰基)氨基)丙酸酯的片劑 (TABLET COMPRISING 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)
Moldova, Republic of	20140058	Compoziţii şi metode de tratament al hepatitei virale C (Compositions and methods for treating hepatitis C virus)

Supplementary Protection Certificates for EPCLUSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	67/2014	Austria		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462	2014/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2203462	C20140035 00135	Estonia		PRODUCT NAME: SOFOSBUVIIR
2203462	92600	Luxembourg		PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR 20140117
2203462	C300704	Netherlands		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462	C 2014 043	Romania		PRODUCT NAME: SOFOSBUVIR; NATIONAL AUTHORISATION NUMBER: EU/1/13/894(001-002); DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/894(001-002); DATE OF FIRST AUTHORISATION IN EEA: 20140116
2203462	SPC/GB14/078	United Kingdom		PRODUCT NAME: SOFOSBUVIR; REGISTERED: UK EU/1/13/894/001 20140117; UK EU/1/13/894/002 20140117