Details for New Drug Application (NDA): 209606
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NDA 209606 describes IDHIFA, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the IDHIFA profile page.
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.
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: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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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