Harvoni is a drug owned by Gilead Sciences Inc. It is protected by 33 US drug patents filed from 2014 to 2019 out of which none have expired yet. Harvoni's patents have been open to challenges since 08 October, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 30, 2034. Details of Harvoni'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. | |||
| US10039779 | Combination formulation of two antiviral compounds |
Jan, 2034
(9 years from now) | Active |
| US8618076 | Nucleoside phosphoramidates |
Dec, 2030
(5 years from now) | Active |
| US9284342 | Nucleoside phosphoramidates |
Sep, 2030
(5 years from now) | Active |
| US8822430 | Antiviral compounds |
May, 2030
(5 years from now) | Active |
| US8088368 | Antiviral compounds |
May, 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 |
| US8334270 | NA |
Mar, 2028
(3 years from now) | Active |
| US8580765 | NA |
Mar, 2028
(3 years from now) | Active |
| US9085573 | 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). | |||
|
US10039779 (Pediatric) | Combination formulation of two antiviral compounds |
Jul, 2034
(9 years from now) | Active |
|
US9393256 (Pediatric) | Methods for treating HCV |
Mar, 2033
(8 years from now) | Active |
| US10456414 | Methods for treating HCV |
Sep, 2032
(7 years from now) | Active |
| US9393256 | Methods for treating HCV |
Sep, 2032
(7 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 |
|
US9511056 (Pediatric) | Antiviral compounds |
Nov, 2030
(5 years from now) | Active |
|
US8822430 (Pediatric) | Antiviral compounds |
Nov, 2030
(5 years from now) | Active |
|
US8088368 (Pediatric) | Antiviral compounds |
Nov, 2030
(5 years from now) | Active |
|
US8273341 (Pediatric) | Antiviral compounds |
Nov, 2030
(5 years from now) | Active |
|
US8841278 (Pediatric) | Antiviral compounds |
Nov, 2030
(5 years from now) | Active |
| US9511056 | Antiviral compounds |
May, 2030
(5 years from now) | Active |
| US8273341 | Antiviral compounds |
May, 2030
(5 years from now) | Active |
| US8841278 | Antiviral compounds |
May, 2030
(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
(4 years from now) | Active |
|
US9085573 (Pediatric) | NA |
Sep, 2028
(3 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 |
| 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 Harvoni's patents.
Latest Legal Activities on Harvoni's Patents
Given below is the list of recent legal activities going on the following patents of Harvoni.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Jun, 2024 | US8334270 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 May, 2024 | US9511056 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Mar, 2024 | US8273341 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Jan, 2024 | US9393256 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Jun, 2023 | US8088368 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Apr, 2023 | US10456414 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Jan, 2023 | US9085573 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 Dec, 2022 | US7964580 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 May, 2022 | US8889159 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Mar, 2022 | US8841278 |
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 Harvoni and ongoing litigations to help you estimate the early arrival of Harvoni generic.
Harvoni's Litigations
Harvoni 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 Harvoni'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. |
| US9393256 | December, 2017 |
Terminated-Denied
(20 Jun, 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 Harvoni. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Harvoni, 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 Harvoni.
Exclusivity Information
Harvoni holds 17 exclusivities out of which 14 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Harvoni's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-153) | Nov 12, 2018 |
| New Indication(I-718) | Nov 12, 2018 |
| New Indication(I-719) | Nov 12, 2018 |
| New Indication(I-720) | Nov 12, 2018 |
| New Dosing Schedule(D-158) | Feb 12, 2019 |
| New Dosing Schedule(D-159) | Feb 12, 2019 |
| New Dosing Schedule(D-160) | Feb 12, 2019 |
| New Chemical Entity Exclusivity(NCE) | Oct 10, 2019 |
| New Patient Population(NPP) | Apr 07, 2020 |
| New Dosing Schedule(D-177) | Nov 15, 2022 |
| Orphan Drug Exclusivity(ODE) | Apr 07, 2024 |
| ODE*(ODE*) | Aug 28, 2026 |
| Orphan Drug Exclusivity(ODE-136) | Apr 07, 2024 |
| Pediatric Exclusivity(PED) | Oct 07, 2024 |
| Orphan Drug Exclusivity(ODE-262) | Aug 28, 2026 |
| Orphan Drug Exclusivity(ODE-263) | Aug 28, 2026 |
| Orphan Drug Exclusivity(ODE-264) | Aug 28, 2026 |
Several oppositions have been filed on Harvoni'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 Harvoni's generic, the next section provides detailed information on ongoing and past EP oppositions related to Harvoni patents.
Harvoni's Oppositions Filed in EPO
Harvoni 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 Harvoni 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 Harvoni's family patents as well as insights into ongoing legal events on those patents.
Harvoni's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Harvoni'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)
Harvoni Generics:
There are no approved generic versions for Harvoni as of now.
Alternative Brands for Harvoni
Harvoni which is used for treating chronic Hepatitis C virus (HCV) infection in treatment-naive genotype 1 patients for an 8-week duration., has several other brand drugs in the same treatment category . 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.
About Harvoni
Harvoni is a drug owned by Gilead Sciences Inc. It is used for treating chronic Hepatitis C virus (HCV) infection in treatment-naive genotype 1 patients for an 8-week duration. Harvoni uses Ledipasvir; Sofosbuvir as an active ingredient. Harvoni was launched by Gilead Sciences Inc in 2019.
Approval Date:
Harvoni was approved by FDA for market use on 28 August, 2019.
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 Harvoni is 28 August, 2019, its NCE-1 date is estimated to be 08 October, 2023.
Active Ingredient:
Harvoni uses Ledipasvir; Sofosbuvir as the active ingredient. Check out other Drugs and Companies using Ledipasvir; Sofosbuvir ingredient
Treatment:
Harvoni is used for treating chronic Hepatitis C virus (HCV) infection in treatment-naive genotype 1 patients for an 8-week duration.
Dosage:
Harvoni is available in the following dosage forms - tablet form for oral use, pellets form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 45MG;200MG | TABLET | Prescription | ORAL |
| 90MG;400MG | TABLET | Prescription | ORAL |
| 45MG;200MG/PACKET | PELLETS | Prescription | ORAL |
| 33.75MG;150MG/PACKET | PELLETS | Prescription | ORAL |