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. Epclusa's patents will be open to challenges from 19 September, 2026. 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. | |||
| US8940718 | Antiviral compounds |
Nov, 2032
(7 years from now) | Active |
| US8575135 | Antiviral compounds |
Nov, 2032
(7 years from now) | Active |
| US8921341 | 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
(3 years from now) | Active |
| US8633309 | Nucleoside phosphoramidates |
Mar, 2029
(3 years from now) | Active |
| US9085573 | NA |
Mar, 2028
(2 years from now) | Active |
| US8580765 | NA |
Mar, 2028
(2 years from now) | Active |
| US8334270 | NA |
Mar, 2028
(2 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). | |||
|
US10086011 (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 |
|
US11116783 (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 |
| US9757406 | Combination formulation of two antiviral compounds |
Jan, 2034
(8 years from now) | Active |
| US10086011 | Combination formulation of two antiviral compounds |
Jan, 2034
(8 years from now) | Active |
| US11116783 | Combination formulation of two antiviral compounds |
Jan, 2034
(8 years from now) | Active |
| US11707479 | Combination formulation of two antiviral compounds |
Jan, 2034
(8 years from now) | Active |
|
US8940718 (Pediatric) | Antiviral compounds |
May, 2033
(7 years from now) | Active |
|
US8921341 (Pediatric) | Antiviral compounds |
May, 2033
(7 years from now) | Active |
|
US8575135 (Pediatric) | Antiviral compounds |
May, 2033
(7 years from now) | Active |
|
US8618076 (Pediatric) | Nucleoside phosphoramidates |
Jun, 2031
(5 years from now) | Active |
|
US9284342 (Pediatric) | Nucleoside phosphoramidates |
Mar, 2031
(5 years from now) | Active |
|
US8889159 (Pediatric) | Compositions and methods for treating hepatitis C virus |
Sep, 2029
(4 years from now) | Active |
|
US7964580 (Pediatric) | NA |
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
(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 (Pediatric) | NA |
Sep, 2028
(3 years from now) | Active |
| US8735372 | NA |
Mar, 2028
(2 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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 25 Jul, 2023 | US11707479 |
| Patent eGrant Notification | 25 Jul, 2023 | US11707479 |
| Email Notification Critical | 25 Jul, 2023 | US11707479 |
| Electronic Review Critical | 25 Jul, 2023 | US11707479 |
| Recordation of Patent Grant Mailed Critical | 25 Jul, 2023 | US11707479 |
| Electronic Review Critical | 06 Jul, 2023 | US11707479 |
| Email Notification Critical | 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 10 exclusivities out of which 6 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 |
| ODE*(ODE*) | Mar 19, 2027 |
| Orphan Drug Exclusivity(ODE-293) | Mar 19, 2027 |
| Pediatric Exclusivity(PED) | Dec 10, 2028 |
| Orphan Drug Exclusivity(ODE-376) | Jun 10, 2028 |
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 |
|---|---|---|---|
| | |||
| 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
Explore Our Curated Drug Screens
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.
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 |
|
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 2020.
Approval Date:
Epclusa was approved by FDA for market use on 19 March, 2020.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Epclusa is 19 March, 2020, its NCE-1 date is estimated to be 19 September, 2026.
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 |
|---|---|---|---|
| 400MG;100MG | TABLET | Prescription | ORAL |
| 200MG;50MG/PACKET | PELLETS | Prescription | ORAL |
| 150MG;37.5MG/PACKET | PELLETS | Prescription | ORAL |
| 200MG;50MG | TABLET | Prescription | ORAL |