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Last Updated: September 22, 2021

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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. There are twenty-three patents protecting this drug. Additional details are available on the TAZVERIK profile page.

The generic ingredient in TAZVERIK is tazemetostat hydrobromide. Additional details are available on the tazemetostat hydrobromide profile page.
Summary for 211723
Tradename:TAZVERIK
Applicant:Epizyme Inc
Ingredient:tazemetostat hydrobromide
Patents:23
DrugPatentWatch® Estimated Generic Entry Opportunity 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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Jan 23, 2020TE: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
Regulatory Exclusivity Expiration:Jan 23, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.