Details for New Drug Application (NDA): 209606
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The generic ingredient in IDHIFA is enasidenib mesylate. One supplier is listed for this compound. Additional details are available on the enasidenib mesylate profile page.
Summary for 209606
Tradename: | IDHIFA |
Applicant: | Bristol Myers Squibb |
Ingredient: | enasidenib mesylate |
Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209606
Generic Entry Date for 209606*:
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: 209606
Mechanism of Action | Isocitrate Dehydrogenase 2 Inhibitors |
Suppliers and Packaging for NDA: 209606
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606 | NDA | Celgene Corporation | 59572-705 | 59572-705-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59572-705-30) |
IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606 | NDA | Celgene Corporation | 59572-710 | 59572-710-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59572-710-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Aug 1, 2017 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Aug 1, 2024 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 1, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 7, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION |
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