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Last Updated: May 22, 2022

EPCLUSA Drug Patent Profile


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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

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Drug patent expirations by year for EPCLUSA
Drug Prices for EPCLUSA

See drug prices for EPCLUSA

DrugPatentWatch® Estimated Generic Entry Opportunity 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
Cairns Hinterland Health Hospital and Health ServicesPhase 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 fifteen US patents and eleven FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EPCLUSA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination formulation of two antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treating hepatitis C virus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination formulation of two antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

NEW STRENGTH
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS
Exclusivity Expiration: See Plans and Pricing

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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: See Plans and Pricing

Australia

Patent: 14311827
Estimated Expiration: See Plans and Pricing

Patent: 17276223
Estimated Expiration: See Plans and Pricing

Patent: 19264624
Estimated Expiration: See Plans and Pricing

Canada

Patent: 21160
Estimated Expiration: See Plans and Pricing

China

Patent: 5517540
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1690473
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 38601
Estimated Expiration: See Plans and Pricing

Patent: 50014
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 20392
Estimated Expiration: See Plans and Pricing

Patent: 25626
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3988
Estimated Expiration: See Plans and Pricing

Japan

Patent: 60607
Estimated Expiration: See Plans and Pricing

Patent: 16529293
Estimated Expiration: See Plans and Pricing

Patent: 17222718
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 16002185
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 6840
Estimated Expiration: See Plans and Pricing

Poland

Patent: 38601
Estimated Expiration: See Plans and Pricing

Patent: 50014
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 38601
Estimated Expiration: See Plans and Pricing

Patent: 50014
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201600919U
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 38601
Estimated Expiration: See Plans and Pricing

Patent: 50014
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2239196
Estimated Expiration: See Plans and Pricing

Patent: 160047522
Estimated Expiration: See Plans and Pricing

Spain

Patent: 92503
Estimated Expiration: See Plans and Pricing

Patent: 00570
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 26048
Estimated Expiration: See Plans and Pricing

Patent: 1511756
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 300
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
European Patent Office 3778606 IMIDAZOLYLIMIDAZOLES CONDENSÉS EN TANT QUE COMPOSÉS ANTIVIRAUX (CONDENSED IMIDAZOLYLIMIDAZOLES AS ANTIVIRAL COMPOUNDS) See Plans and Pricing
European Patent Office 2801580 Promédicaments de phosphoramidate de nucléoside (Nucleoside phosphoramidate prodrugs) See Plans and Pricing
Mexico 2014003145 METODOS PARA EL TRATAMIENTO DE VHC. (METHODS FOR TREATING HCV.) See Plans and Pricing
European Patent Office 2752422 Synthèse stéréosélective d'agents actifs contenant du phosphore (Stereoselective synthesis of phosphorus containing actives) See Plans and Pricing
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) See Plans and Pricing
Denmark 2635588 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EPCLUSA

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

Mallinckrodt
Johnson and Johnson
Merck
Moodys
Boehringer Ingelheim
Dow

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.