Zepatier is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is protected by 2 US drug patents filed in 2016 out of which none have expired yet. Zepatier's patents have been open to challenges since 29 January, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be May 04, 2031. Details of Zepatier'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. | |||
| US8871759 | Inhibitors of hepatitis C virus replication |
May, 2031
(6 years from now) | Active |
| US7973040 | Macrocyclic quinoxaline compounds as HCV NS3 protease inhibitors |
Jul, 2029
(4 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 Zepatier's patents.
Latest Legal Activities on Zepatier's Patents
Given below is the list of recent legal activities going on the following patents of Zepatier.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Dec, 2022 | US7973040 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Mar, 2022 | US8871759 |
| Patent Term Extension Certificate Critical | 10 Dec, 2021 | US7973040 |
| Notice of Final Determination -Eligible | 09 Mar, 2021 | US7973040 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Dec, 2018 | US7973040 |
| FDA Final Eligibility Letter Critical | 10 Oct, 2018 | US7973040 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Mar, 2018 | US8871759 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2018 | US7973040 |
| transaction for FDA Determination of Regulatory Review Period | 21 Nov, 2017 | US7973040 |
| Second letter to regulating agency to determine regulatory review period | 05 Sep, 2017 | US7973040 |
FDA has granted several exclusivities to Zepatier. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zepatier, 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 Zepatier.
Exclusivity Information
Zepatier holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Zepatier's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 28, 2021 |
| New Patient Population(NPP) | Dec 09, 2024 |
US patents provide insights into the exclusivity only within the United States, but Zepatier 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 Zepatier's family patents as well as insights into ongoing legal events on those patents.
Zepatier's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zepatier's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 04, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zepatier Generics:
There are no approved generic versions for Zepatier as of now.
About Zepatier
Zepatier is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is used for treating patients infected with hepatitis C virus. Zepatier uses Elbasvir; Grazoprevir as an active ingredient. Zepatier was launched by Msd Sub Merck in 2016.
Can you believe Zepatier received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Zepatier was approved by FDA for market use on 28 January, 2016.
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 Zepatier is 28 January, 2016, its NCE-1 date is estimated to be 29 January, 2020.
Active Ingredient:
Zepatier uses Elbasvir; Grazoprevir as the active ingredient. Check out other Drugs and Companies using Elbasvir; Grazoprevir ingredient
Treatment:
Zepatier is used for treating patients infected with hepatitis C virus.
Dosage:
Zepatier is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG;100MG | TABLET | Prescription | ORAL |