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The generic ingredient in TIBSOVO is ivosidenib. Additional details are available on the ivosidenib profile page.
Generic Entry Opportunity Date for 211192
*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
|Approval Date:||Jul 20, 2018||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Jul 20, 2025|
|Regulatory Exclusivity Use:||INDICATED 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|
|Regulatory Exclusivity Expiration:||Jul 20, 2023|
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Regulatory Exclusivity Expiration:||May 2, 2022|
|Regulatory Exclusivity Use:||TREATMENT 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|
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