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Generated: November 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209606

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NDA 209606 describes IDHIFA, which is a drug marketed by Celgene Corp and is included in one NDA. It is available from one supplier. There are three 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.
Summary for 209606
Tradename:IDHIFA
Applicant:Celgene Corp
Ingredient:enasidenib mesylate
Patents:3
Generic Entry Opportunity 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
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:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Aug 1, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 1, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
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 UpPatent Expiration:Jan 7, 2033Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION

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