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  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
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Patent and Exclusivity for: N211723

Product 001
TAZEMETOSTAT HYDROBROMIDE (TAZVERIK) TABLET EQ 200MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8410088 04/13/2032 DS DP
02/19/2020
001 8691507 09/12/2031
U-2852 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA POSITIVE FOR AN ENHANCER OF ZESTE HOMOLOG 2 (EZH2) MUTATION
07/16/2020
001 8765732 04/13/2032
U-2852 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA POSITIVE FOR AN ENHANCER OF ZESTE HOMOLOG 2 (EZH2) MUTATION
U-2853 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA
07/16/2020
001 8895245 09/12/2031
U-2852 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA POSITIVE FOR AN ENHANCER OF ZESTE HOMOLOG 2 (EZH2) MUTATION
07/16/2020
001 9090562 04/13/2032 DS DP
02/19/2020
001 9175331 09/12/2031
U-2852 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA POSITIVE FOR AN ENHANCER OF ZESTE HOMOLOG 2 (EZH2) MUTATION
07/16/2020
001 9333217 09/12/2031
U-2852 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA POSITIVE FOR AN ENHANCER OF ZESTE HOMOLOG 2 (EZH2) MUTATION
07/16/2020
001 9334527 09/12/2031
U-2852 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA POSITIVE FOR AN ENHANCER OF ZESTE HOMOLOG 2 (EZH2) MUTATION
07/16/2020
001 9394283 04/11/2033 DS DP
U-2852 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA POSITIVE FOR AN ENHANCER OF ZESTE HOMOLOG 2 (EZH2) MUTATION
U-2853 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA
02/19/2020
001 9522152 04/13/2032
U-2738 METHOD OF TREATING A LUNG METASTASIS OF EPITHELIOID SARCOMA
02/19/2020
001 9549931 04/13/2032
U-2736 METHOD OF TREATING EPITHELIOID SARCOMA
U-2852 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA POSITIVE FOR AN ENHANCER OF ZESTE HOMOLOG 2 (EZH2) MUTATION
U-2853 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA
02/19/2020
001 9688665 08/22/2034
U-2736 METHOD OF TREATING EPITHELIOID SARCOMA
02/19/2020
001 9855275 04/13/2032
U-2736 METHOD OF TREATING EPITHELIOID SARCOMA
02/19/2020
001 9872862 04/11/2033
U-2738 METHOD OF TREATING A LUNG METASTASIS OF EPITHELIOID SARCOMA
02/19/2020
001 9889138 10/16/2035
U-2736 METHOD OF TREATING EPITHELIOID SARCOMA
U-2852 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA POSITIVE FOR AN ENHANCER OF ZESTE HOMOLOG 2 (EZH2) MUTATION
U-2853 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA
02/19/2020
001 9949999 09/12/2031
U-2851 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA POSITIVE FOR AN ENHANCER OF ZESTE HOMOLOG 2 (EZH2) MUTATION BY INHIBITING EZH2
07/16/2020
001 10155002 04/13/2032
U-2736 METHOD OF TREATING EPITHELIOID SARCOMA
02/19/2020
001 10245269 04/11/2033
U-2737 METHOD OF TREATING EPITHELIOID SARCOMA BY INHIBITING ENHANCER OF ZESTE HOMOLOG 2 (EZH2)
U-2851 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA POSITIVE FOR AN ENHANCER OF ZESTE HOMOLOG 2 (EZH2) MUTATION BY INHIBITING EZH2
U-2854 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA BY INHIBITING EZH2
02/19/2020
001 10369155 10/16/2035
U-2736 METHOD OF TREATING EPITHELIOID SARCOMA
U-2852 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA POSITIVE FOR AN ENHANCER OF ZESTE HOMOLOG 2 (EZH2) MUTATION
U-2853 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA
02/19/2020
001 10420775 04/13/2032
U-2736 METHOD OF TREATING EPITHELIOID SARCOMA
U-2852 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA POSITIVE FOR AN ENHANCER OF ZESTE HOMOLOG 2 (EZH2) MUTATION
U-2853 METHOD OF TREATING RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA
02/19/2020
001 10786511 12/19/2035 DP
10/26/2020
001 10821113 04/11/2033 DS DP
11/24/2020
001 11052093 04/13/2032 DS DP
U-2736 METHOD OF TREATING EPITHELIOID SARCOMA
U-3179 METHOD OF TREATING FOLLICULAR LYMPHOMA
08/03/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
I-835TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL) 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
COMPETITIVE GENERIC THERAPY
06/18/2023
001
I-836TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL) WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
COMPETITIVE GENERIC THERAPY
06/18/2023
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
01/23/2025
001
ODE-299INDICATED 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
COMPETITIVE GENERIC THERAPY
01/23/2027
001
ODE-314INDICATED 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
COMPETITIVE GENERIC THERAPY
06/18/2027

 

 


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