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Last Updated: June 21, 2024

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EPCLUSA Drug Patent Profile


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When do Epclusa patents expire, and what generic alternatives are available?

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

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Drug patent expirations by year for EPCLUSA
Drug Prices for EPCLUSA

See drug prices for EPCLUSA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EPCLUSA
Generic Entry Dates for EPCLUSA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL
Generic Entry Dates for EPCLUSA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Peking University People's HospitalPhase 4
Macfarlane Burnet Institute for Medical Research and Public Health LtdPhase 4
The University of QueenslandPhase 4

See all EPCLUSA clinical trials

US Patents and Regulatory Information for EPCLUSA

EPCLUSA is protected by sixteen US patents and seven FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EPCLUSA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Combination formulation of two antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Combination formulation of two antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidates
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidates
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions and methods for treating hepatitis C virus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidates
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Combination formulation of two antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting EPCLUSA

FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 6 YEARS OF AGE WEIGHING LESS THAN 17 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
Exclusivity Expiration: ⤷  Sign Up

UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

TX OF PED PTS 6 YRS OF AGE & OLDER OR WEIGHING AT LEAST 17 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
Exclusivity Expiration: ⤷  Sign Up

INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir PELLETS;ORAL 214187-002 Jun 10, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 5133
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 14311827
Estimated Expiration: ⤷  Sign Up

Patent: 17276223
Estimated Expiration: ⤷  Sign Up

Patent: 19264624
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 21160
Estimated Expiration: ⤷  Sign Up

China

Patent: 5517540
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1690473
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 38601
Estimated Expiration: ⤷  Sign Up

Patent: 50014
Estimated Expiration: ⤷  Sign Up

Patent: 05560
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 20392
Estimated Expiration: ⤷  Sign Up

Patent: 25626
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 60607
Estimated Expiration: ⤷  Sign Up

Patent: 16529293
Estimated Expiration: ⤷  Sign Up

Patent: 17222718
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 16002185
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 6840
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 38601
Estimated Expiration: ⤷  Sign Up

Patent: 50014
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 38601
Estimated Expiration: ⤷  Sign Up

Patent: 50014
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201600919U
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 38601
Estimated Expiration: ⤷  Sign Up

Patent: 50014
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2239196
Estimated Expiration: ⤷  Sign Up

Patent: 160047522
Patent: 2종의 항바이러스 화합물의 조합 제제 (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 92503
Estimated Expiration: ⤷  Sign Up

Patent: 00570
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 26048
Estimated Expiration: ⤷  Sign Up

Patent: 1511756
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 300
Estimated Expiration: ⤷  Sign Up

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
Poland 2432792 ⤷  Sign Up
Singapore 10201500835W N- [ (2 ' R) -2 ' -DEOXY-2 ' -FLUORO-2 ' -METHYL-P-PHENYL-5 ' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION ⤷  Sign Up
Mexico 2014003145 METODOS PARA EL TRATAMIENTO DE VHC. (METHODS FOR TREATING HCV.) ⤷  Sign Up
Taiwan 201704249 Nucleoside phosphoramidates ⤷  Sign Up
Hungary E034239 ⤷  Sign Up
Japan 5885659 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EPCLUSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 SPC/GB14/078 United Kingdom ⤷  Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTERED: UK EU/1/13/894/001 20140117; UK EU/1/13/894/002 20140117
2203462 67/2014 Austria ⤷  Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462 CR 2014 00061 Denmark ⤷  Sign Up PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140117
2203462 92600 Luxembourg ⤷  Sign Up PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR 20140117
2203462 PA2014040 Lithuania ⤷  Sign Up PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462 214 5029-2014 Slovakia ⤷  Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.