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Generic Iclusig Availability

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

ICLUSIG (ponatinib hydrochloride - tablet;oral)

  • Manufacturer: ARIAD
    Approval date: December 14, 2012
    Strength(s): EQ 15MG BASE, EQ 45MG BASE [RLD]
  • Manufacturer: ARIAD
    Approval date: April 23, 2015
    Strength(s): EQ 30MG BASE

Has a generic version of Iclusig been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Iclusig. 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: About generic drugs.

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.

  • Substituted acetylenic imidazo[1,2-B]pyridazine compounds as kinase inhibitors
    Patent 8,114,874
    Issued: February 14, 2012
    Inventor(s): Zou; Dong & Huang; Wei-Sheng & Thomas; R. Mathew & Romero; Jan Antionette C. & Qi; Jiwei & Wang; Yihan & Zhu; Xiaotian & Shakespeare; William C. & Sundaramoorthi; Rajeswari & Metcalf, III; Chester A. & Dalgarno; David C. & Sawyer; Tomi K.
    Assignee(s): ARIAD Pharmaceuticals, Inc.
    This invention relates to compounds of the general formula: in which the variable groups are as defined herein, and to their preparation and use. In particular, the compounds include embodiments in which Ring T is an imidazo[1,2-b]pyridazine ring system, Rings A and B are each aryl and L1 is —C(O)NR1— or —NR1C(O)—. Uses for the compounds and for compositions containing them include treatment of cancer and other diseases mediated by protein kinases.
    Patent expiration dates:
    • December 22, 2026
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      Drug substance
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      Drug product
  • Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors
    Patent 9,029,533
    Issued: May 12, 2015
    Assignee(s): ARIAD Pharmaceuticals, Inc.
    This invention relates to compounds of the general formula: in which the variable groups are as defined herein, and to their preparation and use.
    Patent expiration dates:
    • December 22, 2026
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      Patent use: A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
    • December 22, 2026
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      Patent use: A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA
    • December 22, 2026
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      Patent use: A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
    • December 22, 2026
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      Patent use: A METHOD FOR THE TREATMENT OF LEUKEMIAS
    • December 22, 2026
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      Patent use: A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA

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:
    • December 14, 2017 - NEW CHEMICAL ENTITY
    • December 14, 2019 - 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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