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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: N211192

Product 001
IVOSIDENIB (TIBSOVO) TABLET 250MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 9474779 08/19/2033 DS DP
U-2350 A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS ACUTE MYELOGENOUS LEUKEMIA (AML)
U-2533 A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML)
U-2534 A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML)
08/13/2018
001 9850277 01/18/2033 DS DP
U-2350 A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS ACUTE MYELOGENOUS LEUKEMIA (AML)
U-2533 A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML)
U-2534 A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML)
08/13/2018
001 9968595 03/13/2035 DP
U-2351 TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH AN IDH1 MUTATION
U-2533 A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML)
U-2534 A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML)
08/13/2018
001 10449184 03/13/2035 DP
11/12/2019
001 10610125 06/21/2030
U-2784 A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) AND WHERE THE MUTANT IDH1 HAS THE ABILITY TO CONVERT ALPHA-KETOGLUTARATE INTO 2-HYDROXYGLUTARATE (2-HG)
U-2785 A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) AND WHERE THE MUTANT IDH1 HAS THE ABILITY TO CONVERT ALPHA-KETOGLUTARATE INTO 2-HYDROXYGLUTARATE (2-HG)
04/28/2020
001 10799490 03/13/2035 DP
U-2981 A METHOD OF TREATING ACUTE MYELOGENOUS LEUKEMIA (AML) IN A SUBJECT BY ADMINISTERING A PHARMACEUTICAL COMPOSITION WHERE THE AML IS CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 AND THE AML IS NEWLY DIAGNOSED
U-2982 A METHOD OF TREATING ACUTE MYELOGENOUS LEUKEMIA (AML) IN A SUBJECT BY ADMINISTERING A PHARMACEUTICAL COMPOSITION WHERE THE AML IS CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 AND WHERE THE AML IS RELAPSED/REFRACTORY
11/06/2020
001 10980788 06/07/2039
U-3112 TREATING NEWLY DIAGNOSED ACUTE MYELOGENOUS LEUKEMIA (AML) CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL
U-3113 TREATING RELAPSED/REFRACTORY ACUTE MYELOGENOUS LEUKEMIA (AML) CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL
05/20/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
I-816TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WHO ARE >= 75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
COMPETITIVE GENERIC THERAPY
05/02/2022
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
07/20/2023
001
ODE-203INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
COMPETITIVE GENERIC THERAPY
07/20/2025
001
ODE-242TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 MUTATION AS DETECTED BY AN FDA-APPROVED TEST IN ADULT PTS WHO ARE >=75 YRS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
COMPETITIVE GENERIC THERAPY
05/02/2026

 

 


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