Tazverik is a drug owned by Epizyme Inc. It is protected by 24 US drug patents filed from 2020 to 2022 out of which none have expired yet. Tazverik's patents have been open to challenges since 24 January, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 19, 2035. Details of Tazverik'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. | |||
| US8410088 | Aryl- or heteroaryl-substituted benzene compounds |
Jan, 2034
(9 years from now) | Active |
| US10821113 | Salt form of a human histone methyltransferase EZH2 inhibitor |
Apr, 2033
(8 years from now) | Active |
| US9394283 | Salt form of a human histone methyltransferase EZH2 inhibitor |
Apr, 2033
(8 years from now) | Active |
| US11052093 | Aryl-or heteroaryl-substituted benzene compounds |
Apr, 2032
(7 years from now) | Active |
| US9090562 | Aryl- or heteroaryl-substituted benzene compounds |
Sep, 2031
(6 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). | |||
| US10786511 | Method for treating cancer |
Dec, 2035
(11 years from now) | Active |
| US9889138 | Method for treating cancer |
Oct, 2035
(10 years from now) | Active |
| US10369155 | Method for treating cancer |
Oct, 2035
(10 years from now) | Active |
| US9688665 | Methods of treating cancer |
Aug, 2034
(9 years from now) | Active |
| US9872862 | Salt form of a human histone methyltransferase EZH2 inhibitor |
Apr, 2033
(8 years from now) | Active |
| US10245269 | Salt form of a human histone methyltransferase EZH2 inhibitor |
Apr, 2033
(8 years from now) | Active |
| US11491163 | Salt form of a human histone methyltransferase EZH2 inhibitor |
Apr, 2033
(8 years from now) | Active |
| US9522152 | Aryl- or heteroaryl-substituted benzene compounds |
Apr, 2032
(7 years from now) | Active |
| US8765732 | Aryl- or heteroaryl-substituted benzene compounds |
Sep, 2031
(6 years from now) | Active |
| US9549931 | Aryl- or heteroaryl-substituted benzene compounds |
Sep, 2031
(6 years from now) | Active |
| US9334527 | Inhibitors of human EZH2, and methods of use thereof |
Sep, 2031
(6 years from now) | Active |
| US9333217 | Inhibitors of human EZH2, and methods of use thereof |
Sep, 2031
(6 years from now) | Active |
| US8691507 | Inhibitors of human EZH2 and methods of use thereof |
Sep, 2031
(6 years from now) | Active |
| US9175331 | Inhibitors of human EZH2, and methods of use thereof |
Sep, 2031
(6 years from now) | Active |
| US8895245 | Inhibitors of human EZH2 and methods of use thereof |
Sep, 2031
(6 years from now) | Active |
| US9949999 | Inhibitors of human EZH2, and methods of use thereof |
Sep, 2031
(6 years from now) | Active |
| US10420775 | Aryl-or heteroaryl-substituted benzene compounds |
Sep, 2031
(6 years from now) | Active |
| US10155002 | Aryl- or heteroaryl-substituted benzene compounds |
Sep, 2031
(6 years from now) | Active |
| US9855275 | Aryl-or heteroaryl-substituted benzene compounds |
Sep, 2031
(6 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 Tazverik's patents.
Latest Legal Activities on Tazverik's Patents
Given below is the list of recent legal activities going on the following patents of Tazverik.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Jul, 2024 | US9549931 |
| Patent eCofC Notification | 11 Jun, 2024 | US9394283 |
| Recordation of Patent eCertificate of Correction | 11 Jun, 2024 | US9394283 |
| Mail Patent eCofC Notification | 11 Jun, 2024 | US9394283 |
| Email Notification Critical | 11 Jun, 2024 | US9394283 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Jun, 2024 | US9522152 |
| Email Notification Critical | 17 Apr, 2024 | US9889138 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Apr, 2024 | US10821113 |
| Email Notification Critical | 16 Apr, 2024 | US9889138 |
| Mail Patent eCofC Notification | 16 Apr, 2024 | US9889138 |
FDA has granted several exclusivities to Tazverik. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tazverik, 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 Tazverik.
Exclusivity Information
Tazverik holds 5 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Tazverik's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-835) | Jun 18, 2023 |
| New Indication(I-836) | Jun 18, 2023 |
| New Chemical Entity Exclusivity(NCE) | Jan 23, 2025 |
| Orphan Drug Exclusivity(ODE-299) | Jan 23, 2027 |
| Orphan Drug Exclusivity(ODE-314) | Jun 18, 2027 |
Several oppositions have been filed on Tazverik'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 Tazverik's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tazverik patents.
Tazverik's Oppositions Filed in EPO
Tazverik has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 02, 2016, by Glaxosmithkline Intellectual Property (No.2) Limited. This opposition was filed on patent number EP11824247A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP11824247A | Nov, 2016 | GlaxoSmithKline Intellectual Property (No.2) Limited | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Tazverik 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 Tazverik's family patents as well as insights into ongoing legal events on those patents.
Tazverik's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tazverik's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 19, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tazverik Generics:
There are no approved generic versions for Tazverik as of now.
About Tazverik
Tazverik is a drug owned by Epizyme Inc. It is used for treating certain types of sarcoma and relapsed or refractory follicular lymphoma with EZH2 mutations. Tazverik uses Tazemetostat Hydrobromide as an active ingredient. Tazverik was launched by Epizyme Inc in 2020.
Approval Date:
Tazverik was approved by FDA for market use on 23 January, 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 Tazverik is 23 January, 2020, its NCE-1 date is estimated to be 24 January, 2024.
Active Ingredient:
Tazverik uses Tazemetostat Hydrobromide as the active ingredient. Check out other Drugs and Companies using Tazemetostat Hydrobromide ingredient
Treatment:
Tazverik is used for treating certain types of sarcoma and relapsed or refractory follicular lymphoma with EZH2 mutations.
Dosage:
Tazverik is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE | TABLET | Prescription | ORAL |