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Generic Idhifa Availability

Idhifa is a brand name of enasidenib, approved by the FDA in the following formulation(s):

IDHIFA (enasidenib mesylate - tablet;oral)

  • Manufacturer: CELGENE CORP
    Approval date: August 1, 2017
    Strength(s): EQ 50MG BASE [RLD], EQ 100MG BASE [RLD]

Has a generic version of Idhifa been approved?

No. There is currently no therapeutically equivalent version of Idhifa available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Idhifa. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Therapeutically active compositions and their methods of use
    Patent 9,512,107
    Issued: December 6, 2016
    Assignee(s): Agios Pharmaceuticals, Inc.
    Provided are compounds useful for treating cancer and methods of treating cancer comprising administering to a subject in need thereof a compound described herein.
    Patent expiration dates:
    • January 7, 2033
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      Patent use: TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION
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      Drug substance
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      Drug product
  • Therapeutically active compounds and their methods of use
    Patent 9,732,062
    Issued: August 15, 2017
    Assignee(s): Agios Pharmaceuticals, Inc.
    Provided are compounds useful for treating cancer and methods of treating cancer comprising administering to a subject in need thereof a compound described herein.
    Patent expiration dates:
    • September 16, 2034
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      Drug substance
  • Therapeutically active compounds and their methods of use
    Patent 9,738,625
    Issued: August 22, 2017
    Assignee(s): Agios Pharmaceuticals, Inc.
    Provided are isocitrate dehydrogenase 2 (IDH2) inhibitor compounds useful for treating cancer and methods of treating cancer, comprising administering to a subject in need thereof a compound described herein. Also provided are polymorphic forms of the IDH2 inhibitor compounds characterized by X Ray powder diffraction patterns, having improved physicochemical properties that influence in vivo dissolution rate for formulation purposes.
    Patent expiration dates:
    • August 1, 2034
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      Drug substance

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • August 1, 2022 - NEW CHEMICAL ENTITY
    • August 1, 2024 - ORPHAN DRUG EXCLUSIVITY
Glossary
TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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