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Generic Alunbrig Availability

Last updated on July 7, 2021.

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

ALUNBRIG (brigatinib - tablet;oral)

  • Manufacturer: TAKEDA PHARMS USA
    Approval date: April 28, 2017
    Strength(s): 30MG [RLD], 90MG [RLD]
  • Manufacturer: TAKEDA PHARMS USA
    Approval date: October 2, 2017
    Strength(s): 180MG [RLD]

Has a generic version of Alunbrig been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Alunbrig. 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 FAQ.

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.

  • Patent 10,385,078

    Patent expiration dates:

    • November 10, 2035
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      Patent use: TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC)
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      Drug substance
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      Drug product
  • Phosphorous derivatives as kinase inhibitors
    Patent 9,012,462
    Issued: April 21, 2015
    Assignee(s): Ariad Pharmaceuticals, Inc.

    The invention features compounds of the general formula (I) in which the variable groups are as defined herein, and to their preparation and use.

    Patent expiration dates:

    • July 31, 2030
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      Drug substance
  • Phosphorus derivatives as kinase inhibitors
    Patent 9,273,077
    Issued: March 1, 2016
    Assignee(s): ARIAD Pharmaceuticals, Inc.

    The invention features compounds of the general formula: in which the variable groups are as defined herein, and to their preparation and use as protein kinase inhibitors.

    Patent expiration dates:

    • May 21, 2029
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      Patent use: TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC)
  • Methods for inhibiting cell proliferation in ALK-driven cancers
    Patent 9,611,283
    Issued: April 4, 2017
    Assignee(s): Ariad Pharmaceuticals, Inc.

    The invention features a method for treating patients who have an ALK-driven cancer, which is, or has become, refractory to one or more of crizotinib, CH5424802 and ASP3026, or which bears an ALK mutation identified herein, by administering a compound of formula (I) to the patient. The invention also features methods, kits, and compositions for characterizing ALK-driven cancers to determine whether they express an ALK mutant.

    Patent expiration dates:

    • April 10, 2034
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      Patent use: TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC)

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:

    • April 28, 2022 - NEW CHEMICAL ENTITY
    • May 22, 2023 - EXPANDED INDICATION OF THE TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA-APPROVED TEST
    • April 28, 2024 -
    • May 22, 2027 -

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.