Mavyret is a drug owned by Abbvie Inc. It is protected by 20 US drug patents filed from 2018 to 2022 out of which none have expired yet. Mavyret's patents will be open to challenges from 11 December, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 24, 2036. Details of Mavyret'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. | |||
| US9321807 | Crystal forms |
Jun, 2035
(10 years from now) | Active |
| USRE48923 | Crystal forms |
May, 2035
(10 years from now) | Active |
| US8937150 | Anti-viral compounds |
May, 2032
(7 years from now) | Active |
| US8648037 | Macrocyclic proline derived HCV serine protease inhibitors |
Jan, 2032
(7 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). | |||
|
US11246866 (Pediatric) | Solid pharmaceutical compositions for treating HCV |
Dec, 2036
(12 years from now) | Active |
| US11246866 | Solid pharmaceutical compositions for treating HCV |
Jun, 2036
(11 years from now) | Active |
|
US9321807 (Pediatric) | Crystal forms |
Dec, 2035
(11 years from now) | Active |
|
USRE48923 (Pediatric) | Crystal forms |
Nov, 2035
(10 years from now) | Active |
|
US10286029 (Pediatric) | Method for treating HCV |
Sep, 2034
(9 years from now) | Active |
|
US11484534 (Pediatric) | Methods for treating HCV |
Sep, 2034
(9 years from now) | Active |
| US10286029 | Method for treating HCV |
Mar, 2034
(9 years from now) | Active |
| US11484534 | Methods for treating HCV |
Mar, 2034
(9 years from now) | Active |
|
US8937150 (Pediatric) | Anti-viral compounds |
Nov, 2032
(8 years from now) | Active |
|
US8648037 (Pediatric) | Macrocyclic proline derived HCV serine protease inhibitors |
Jul, 2032
(7 years from now) | Active |
|
US9586978 (Pediatric) | Anti-viral compounds |
May, 2031
(6 years from now) | Active |
|
US10039754 (Pediatric) | Anti-viral compounds |
Dec, 2030
(6 years from now) | Active |
|
US10028937 (Pediatric) | Anti-viral compounds |
Dec, 2030
(6 years from now) | Active |
| US9586978 | Anti-viral compounds |
Nov, 2030
(5 years from now) | Active |
| US10039754 | Anti-viral compounds |
Jun, 2030
(5 years from now) | Active |
| US10028937 | Anti-viral compounds |
Jun, 2030
(5 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 Mavyret's patents.
Latest Legal Activities on Mavyret's Patents
Given below is the list of recent legal activities going on the following patents of Mavyret.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Sep, 2023 | US9321807 |
| Post Issue Communication - Certificate of Correction | 12 Jul, 2023 | US11484534 |
| Recordation of Patent Grant Mailed Critical | 01 Nov, 2022 | US11484534 |
| Patent Issue Date Used in PTA Calculation Critical | 01 Nov, 2022 | US11484534 |
| Email Notification Critical | 13 Oct, 2022 | US11484534 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Oct, 2022 | US10286029 |
| Issue Notification Mailed Critical | 12 Oct, 2022 | US11484534 |
| Email Notification Critical | 21 Sep, 2022 | US11484534 |
| Mail Response to 312 Amendment (PTO-271) Critical | 21 Sep, 2022 | US11484534 |
| Dispatch to FDC | 21 Sep, 2022 | US11484534 |
FDA has granted several exclusivities to Mavyret. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mavyret, 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 Mavyret.
Exclusivity Information
Mavyret holds 9 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Mavyret's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-230) | Aug 06, 2021 |
| New Patient Population(NPP) | Apr 30, 2022 |
| New Chemical Entity Exclusivity(NCE) | Aug 03, 2022 |
| New Dosing Schedule(D-175) | Sep 26, 2022 |
| M(M-259) | Apr 10, 2023 |
| Orphan Drug Exclusivity(ODE-232) | Apr 30, 2026 |
| Orphan Drug Exclusivity(ODE-233) | Apr 30, 2026 |
| Orphan Drug Exclusivity(ODE-372) | Jun 10, 2028 |
| Pediatric Exclusivity(PED) | Dec 10, 2028 |
Several oppositions have been filed on Mavyret'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 Mavyret's generic, the next section provides detailed information on ongoing and past EP oppositions related to Mavyret patents.
Mavyret's Oppositions Filed in EPO
Mavyret has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 15, 2016, by Ter Meer Steinmeister & Partner Patentanwälte Mbb. This opposition was filed on patent number EP11727080A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17165207A | May, 2021 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP15176068A | Apr, 2019 | Aechter, Bernd | Revoked |
| EP14719977A | Jan, 2018 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP11727080A | Apr, 2016 | KELTIE LLP | Patent maintained as amended |
| EP11727080A | Apr, 2016 | Ter Meer Steinmeister & Partner Patentanwälte mbB | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Mavyret 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 Mavyret's family patents as well as insights into ongoing legal events on those patents.
Mavyret's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Mavyret's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 24, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mavyret Generics:
There are no approved generic versions for Mavyret as of now.
About Mavyret
Mavyret is a drug owned by Abbvie Inc. It is used for treating chronic hepatitis C virus (HCV) infections across different genotypes and age groups. Mavyret uses Glecaprevir; Pibrentasvir as an active ingredient. Mavyret was launched by Abbvie in 2017.
Approval Date:
Mavyret was approved by FDA for market use on 03 August, 2017.
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 Mavyret is 03 August, 2017, its NCE-1 date is estimated to be 11 December, 2027.
Active Ingredient:
Mavyret uses Glecaprevir; Pibrentasvir as the active ingredient. Check out other Drugs and Companies using Glecaprevir; Pibrentasvir ingredient
Treatment:
Mavyret is used for treating chronic hepatitis C virus (HCV) infections across different genotypes and age groups.
Dosage:
Mavyret 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 |
|---|---|---|---|
| 100MG;40MG | TABLET | Prescription | ORAL |
| 50MG;20MG/PACKET | PELLETS | Prescription | ORAL |