Details for New Drug Application (NDA): 211723
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NDA 211723 describes TAZVERIK, which is a drug marketed by Epizyme Inc and is included in one NDA. It is available from one supplier. There are twenty-seven patents protecting this drug. Additional details are available on the TAZVERIK profile page.
The generic ingredient in TAZVERIK is tazemetostat hydrobromide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tazemetostat hydrobromide profile page.
The generic ingredient in TAZVERIK is tazemetostat hydrobromide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tazemetostat hydrobromide profile page.
Summary for 211723
| Tradename: | TAZVERIK |
| Applicant: | Epizyme Inc |
| Ingredient: | tazemetostat hydrobromide |
| Patents: | 27 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211723
Generic Entry Date for 211723*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 211723
Suppliers and Packaging for NDA: 211723
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAZVERIK | tazemetostat hydrobromide | TABLET;ORAL | 211723 | NDA | Epizyme, Inc. | 72607-100 | 72607-100-00 | 240 TABLET, FILM COATED in 1 BOTTLE (72607-100-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Jan 23, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 18, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA WHOSE TUMORS ARE POSITIVE FOR AN EZH2 MUTATION AS DETECTED BY AN FDA-APPROVED TEST AND WHO HAVE RECEIVED AT LEAST 2 PRIOR SYSTEMIC THERAPIES, AND FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS | ||||||||
| Regulatory Exclusivity Expiration: | Jan 23, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULTS AND PEDIATRIC PATIENTS AGED 16 YEARS AND OLDER WITH METASTATIC OR LOCALLY ADVANCED EPITHELIOID SARCOMA NOT ELIGIBLE FOR COMPLETE RESECTION | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Sep 12, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING EPITHELIOID SARCOMA | ||||||||
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