Epclusa Patent Expiration

Epclusa is a drug owned by Gilead Sciences Inc. It is protected by 32 US drug patents filed from 2016 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 30, 2034. Details of Epclusa's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US8921341 Antiviral compounds
Nov, 2032

(7 years from now)

Active
US8940718 Antiviral compounds
Nov, 2032

(7 years from now)

Active
US8575135 Antiviral compounds
Nov, 2032

(7 years from now)

Active
US8618076 Nucleoside phosphoramidates
Dec, 2030

(5 years from now)

Active
US9284342 Nucleoside phosphoramidates
Sep, 2030

(5 years from now)

Active
US7964580 NA
Mar, 2029

(4 years from now)

Active
US8633309 Nucleoside phosphoramidates
Mar, 2029

(4 years from now)

Active
US9085573 NA
Mar, 2028

(3 years from now)

Active
US8334270 NA
Mar, 2028

(3 years from now)

Active
US8580765 NA
Mar, 2028

(3 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11116783

(Pediatric)

Combination formulation of two antiviral compounds
Jul, 2034

(9 years from now)

Active
US11707479

(Pediatric)

Combination formulation of two antiviral compounds
Jul, 2034

(9 years from now)

Active
US10086011

(Pediatric)

Combination formulation of two antiviral compounds
Jul, 2034

(9 years from now)

Active
US9757406

(Pediatric)

Combination formulation of two antiviral compounds
Jul, 2034

(9 years from now)

Active
US10086011 Combination formulation of two antiviral compounds
Jan, 2034

(9 years from now)

Active
US11707479 Combination formulation of two antiviral compounds
Jan, 2034

(9 years from now)

Active
US9757406 Combination formulation of two antiviral compounds
Jan, 2034

(9 years from now)

Active
US11116783 Combination formulation of two antiviral compounds
Jan, 2034

(9 years from now)

Active
US8575135

(Pediatric)

Antiviral compounds
May, 2033

(8 years from now)

Active
US8940718

(Pediatric)

Antiviral compounds
May, 2033

(8 years from now)

Active
US8921341

(Pediatric)

Antiviral compounds
May, 2033

(8 years from now)

Active
US8618076

(Pediatric)

Nucleoside phosphoramidates
Jun, 2031

(6 years from now)

Active
US9284342

(Pediatric)

Nucleoside phosphoramidates
Mar, 2031

(6 years from now)

Active
US7964580

(Pediatric)

NA
Sep, 2029

(4 years from now)

Active
US8889159

(Pediatric)

Compositions and methods for treating hepatitis C virus
Sep, 2029

(4 years from now)

Active
US8633309

(Pediatric)

Nucleoside phosphoramidates
Sep, 2029

(4 years from now)

Active
US8889159 Compositions and methods for treating hepatitis C virus
Mar, 2029

(4 years from now)

Active
US8735372

(Pediatric)

NA
Sep, 2028

(3 years from now)

Active
US8334270

(Pediatric)

NA
Sep, 2028

(3 years from now)

Active
US8580765

(Pediatric)

NA
Sep, 2028

(3 years from now)

Active
US9085573

(Pediatric)

NA
Sep, 2028

(3 years from now)

Active
US8735372 NA
Mar, 2028

(3 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Epclusa's patents.

Given below is the list of recent legal activities going on the following patents of Epclusa.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 05 Jun, 2024 US8334270
Recordation of Patent eGrant 25 Jul, 2023 US11707479
Mail Patent eGrant Notification 25 Jul, 2023 US11707479
Patent Issue Date Used in PTA Calculation 25 Jul, 2023 US11707479
Patent eGrant Notification 25 Jul, 2023 US11707479
Email Notification 25 Jul, 2023 US11707479
Electronic Review 25 Jul, 2023 US11707479
Recordation of Patent Grant Mailed 25 Jul, 2023 US11707479
Electronic Review 06 Jul, 2023 US11707479
Email Notification 06 Jul, 2023 US11707479


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Epclusa and ongoing litigations to help you estimate the early arrival of Epclusa generic.

Epclusa's Litigations

Epclusa been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 25, 2017, against patent number US7964580. The petitioner Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al., challenged the validity of this patent, with Gilead Pharmasset LLC et al. as the respondent. Click below to track the latest information on how companies are challenging Epclusa's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8889159 December, 2017 Terminated-Denied
(19 Jul, 2018)
Gilead Pharmasset LLC Initiative for Medicines, Access & Knowledge (I-MAK), Inc.
US8735372 November, 2017 Institution Denied
(13 Jun, 2018)
Gilead Pharmasset LLC et al. Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.
US8633309 October, 2017 Institution Denied
(24 May, 2018)
Gilead Pharmasset LLC Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.
US9284342 November, 2017 Institution Denied
(24 May, 2018)
Gilead Pharmasset LLC Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.
US8334270 October, 2017 Institution Denied
(21 May, 2018)
Gilead Pharmasset LLC et al. Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.
US7964580 October, 2017 Institution Denied
(04 May, 2018)
Gilead Pharmasset LLC et al. Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.


FDA has granted some exclusivities to Epclusa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Epclusa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Epclusa.

Exclusivity Information

Epclusa holds 9 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Epclusa's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jun 28, 2021
New Dosing Schedule(D-177) Nov 15, 2022
New Patient Population(NPP) Mar 19, 2023
New Strength(NS) Mar 19, 2023
M(M-264) Jul 14, 2023
M(M-277) Apr 27, 2025
Orphan Drug Exclusivity(ODE-293) Mar 19, 2027
Orphan Drug Exclusivity(ODE-376) Jun 10, 2028
Pediatric Exclusivity(PED) Dec 10, 2028

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Several oppositions have been filed on Epclusa's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Epclusa's generic, the next section provides detailed information on ongoing and past EP oppositions related to Epclusa patents.

Epclusa's Oppositions Filed in EPO

Epclusa has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 10, 2015, by Medecins Du Monde. This opposition was filed on patent number EP08732818A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP12768967A Aug, 2018 Gillard, Richard Edward Patent maintained as amended
EP08732818A Feb, 2015 Actavis Group PTC ehf Granted and Under Opposition
EP08732818A Feb, 2015 Intellectual Property Services (IPS) Granted and Under Opposition
EP08732818A Feb, 2015 STADA Arzneimittel AG Granted and Under Opposition
EP08732818A Feb, 2015 ZBM Patents - Zea, Barlocci & Markvardsen Granted and Under Opposition
EP08732818A Feb, 2015 Generics [UK] Ltd (trading as Mylan) Granted and Under Opposition
EP08732818A Feb, 2015 Teva Pharmaceutical Industries Ltd Granted and Under Opposition
EP08732818A Feb, 2015 Pharmaceutical Works POLPHARMA Granted and Under Opposition
EP08732818A Feb, 2015 Fleischer, Holm Herbert Granted and Under Opposition
EP08732818A Feb, 2015 ELLIS IP LTD Granted and Under Opposition
EP08732818A Feb, 2015 MEDECINS DU MONDE Granted and Under Opposition


US patents provide insights into the exclusivity only within the United States, but Epclusa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Epclusa's family patents as well as insights into ongoing legal events on those patents.

Epclusa's Family Patents

Epclusa has patent protection in a total of 47 countries. It's US patent count contributes only to 17.2% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Epclusa.

Family Patents

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Generic Launch

Generic Release Date:

Epclusa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 30, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Epclusa Generics:

There are no approved generic versions for Epclusa as of now.

Alternative Brands for Epclusa

Epclusa which is used for treating hepatitis C., has several other brand drugs in the same treatment category and using the same active ingredient (Sofosbuvir; Velpatasvir). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Gilead Sciences Inc
Harvoni Used for treating chronic Hepatitis C virus (HCV) infection in treatment-naive genotype 1 patients for an 8-week duration.
Sovaldi used for treating chronic hepatitis C virus infection as part of combination antiviral therapy.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Sofosbuvir; Velpatasvir. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Gilead Sciences Inc
Vosevi






About Epclusa

Epclusa is a drug owned by Gilead Sciences Inc. It is used for treating hepatitis C. Epclusa uses Sofosbuvir; Velpatasvir as an active ingredient. Epclusa was launched by Gilead Sciences Inc in 2021.

Approval Date:

Epclusa was approved by FDA for market use on 10 June, 2021.

Active Ingredient:

Epclusa uses Sofosbuvir; Velpatasvir as the active ingredient. Check out other Drugs and Companies using Sofosbuvir; Velpatasvir ingredient

Treatment:

Epclusa is used for treating hepatitis C.

Dosage:

Epclusa is available in the following dosage forms - pellets form for oral use, tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
150MG;37.5MG/PACKET PELLETS Prescription ORAL
200MG;50MG/PACKET PELLETS Prescription ORAL
400MG;100MG TABLET Prescription ORAL
200MG;50MG TABLET Prescription ORAL