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TAZVERIK Drug Profile
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Which patents cover Tazverik, and when can generic versions of Tazverik launch?
Tazverik is a drug marketed by Epizyme Inc and is included in one NDA. There are twenty patents protecting this drug.
This drug has two hundred and sixty-nine patent family members in thirty-eight countries.
The generic ingredient in TAZVERIK is tazemetostat hydrobromide. Additional details are available on the tazemetostat hydrobromide profile page.
US ANDA Litigation and Generic Entry Outlook for Tazverik
Tazverik will be eligible for patent challenges on January 23, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 11, 2033. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for TAZVERIK
| International Patents: | 269 |
| US Patents: | 20 |
| Applicants: | 1 |
| NDAs: | 1 |
| DailyMed Link: | TAZVERIK at DailyMed |
Generic Entry Opportunity Date for TAZVERIK
Generic Entry Date for TAZVERIK*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
US Patents and Regulatory Information for TAZVERIK
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Epizyme Inc | TAZVERIK | tazemetostat hydrobromide | TABLET;ORAL | 211723-001 | Jan 23, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Epizyme Inc | TAZVERIK | tazemetostat hydrobromide | TABLET;ORAL | 211723-001 | Jan 23, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Epizyme Inc | TAZVERIK | tazemetostat hydrobromide | TABLET;ORAL | 211723-001 | Jan 23, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Epizyme Inc | TAZVERIK | tazemetostat hydrobromide | TABLET;ORAL | 211723-001 | Jan 23, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Epizyme Inc | TAZVERIK | tazemetostat hydrobromide | TABLET;ORAL | 211723-001 | Jan 23, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Epizyme Inc | TAZVERIK | tazemetostat hydrobromide | TABLET;ORAL | 211723-001 | Jan 23, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for TAZVERIK
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2018062535 | Start Trial |
| Russian Federation | 2013150345 | Start Trial |
| Mexico | 2017004969 | Start Trial |
| Japan | 2015533177 | Start Trial |
| China | 104540500 | Start Trial |
| South Korea | 20200003422 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
