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Generic Galafold Availability

Last updated on July 7, 2021.

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

GALAFOLD (migalastat hydrochloride - capsule;oral)

  • Manufacturer: AMICUS THERAPS US
    Approval date: August 10, 2018
    Strength(s): EQ 123MG BASE [RLD]

Has a generic version of Galafold been approved?

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

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

  • Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene
    Patent 10,076,514
    Issued: September 18, 2018
    Assignee(s): Amicus Therapeutics, Inc.

    Provided are methods of treating a patient diagnosed with Fabry disease and methods of enhancing α-galactosidase A in a patient diagnosed with or suspected of having Fabry disease. Certain methods comprise administering to a patient a therapeutically effective dose of a pharmacological chaperone for α-galactosidase A, wherein the patient has a splice site mutation in intron 4 of the nucleic acid sequence encoding α-galactosidase A. Also described are uses of pharmacological chaperones for the treatment of Fabry disease and compositions for use in the treatment of Fabry disease.

    Patent expiration dates:

    • March 15, 2037
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      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Methods of treating fabry patients having renal impairment
    Patent 10,251,873
    Issued: April 9, 2019
    Assignee(s): Amicus Therapeutics, Inc.

    Provided are methods for treatment of Fabry disease in a patient having renal impairment and/or elevated proteinuria. Certain methods comprise administering to the patient about 100 to about 150 mg free base equivalent of migalastat or salt thereof at a frequency of once every other day. Certain methods also provide for the stabilization of renal function, reducing left ventricular mass index, reducing plasma globotriaosylsphingosine and/or increasing α-galactosidase A activity in the patient.

    Patent expiration dates:

    • May 30, 2038
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      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,383,864

    Patent expiration dates:

    • May 16, 2027
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,406,143

    Patent expiration dates:

    • May 16, 2027
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,471,053

    Patent expiration dates:

    • May 30, 2038
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,525,045

    Patent expiration dates:

    • April 28, 2028
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,792,278

    Patent expiration dates:

    • May 30, 2038
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,792,279

    Patent expiration dates:

    • May 30, 2038
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,799,491

    Patent expiration dates:

    • May 30, 2038
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,806,727

    Patent expiration dates:

    • May 30, 2038
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,813,921

    Patent expiration dates:

    • February 12, 2029
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,849,889

    Patent expiration dates:

    • May 30, 2038
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,849,890

    Patent expiration dates:

    • May 30, 2038
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,857,141

    Patent expiration dates:

    • May 30, 2038
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,857,142

    Patent expiration dates:

    • May 30, 2038
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,874,655

    Patent expiration dates:

    • May 30, 2038
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,874,656

    Patent expiration dates:

    • May 30, 2038
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,874,657

    Patent expiration dates:

    • May 30, 2038
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Patent 10,925,866

    Patent expiration dates:

    • April 28, 2028
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Method to predict response to pharmacological chaperone treatment of diseases
    Patent 8,592,362
    Issued: November 26, 2013
    Assignee(s): Amicus Therapeutics, Inc.

    The present invention provides methods to determine whether a patient with a lysosomal storage disorder will benefit from treatment with a specific pharmacological chaperone. The present invention exemplifies an in vitro method for determining α-galactosidase A responsiveness to a pharmacological chaperone such as 1-deoxygalactonojirimycin in a cell line expressing a mutant from of α-galactosidase A. The invention also provides a method for diagnosing Fabry disease in patients suspected of having Fabry disease.

    Patent expiration dates:

    • February 12, 2029
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      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Methods for treatment of Fabry disease
    Patent 9,000,011
    Issued: April 7, 2015
    Assignee(s): Amicus Therapeutics, Inc.

    Provided are in vitro and in vivo methods for determining whether a patient with Fabry disease will respond to treatment with a specific pharmacological chaperone.

    Patent expiration dates:

    • May 16, 2027
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Method to predict response to pharmacological chaperone treatment of diseases
    Patent 9,095,584
    Issued: August 4, 2015
    Assignee(s): AMICUS THERAPEUTICS, INC.

    The present invention provides methods to determine whether a patient with a lysosomal storage disorder win benefit from treatment with a specific pharmacological chaperone. The present invention exemplifies an in vitro method for determining α-galactosidase A responsiveness to a pharmacological chaperone such as 1-deoxygalactonojirimycin in a cell line expressing a mutant from of α-galactosidase A. The invention also provides a method for diagnosing Fabry disease in patients suspected of having Fabry disease.

    Patent expiration dates:

    • February 12, 2029
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Methods for treatment of Fabry disease
    Patent 9,480,682
    Issued: November 1, 2016
    Assignee(s): Amicus Therapeutics, Inc.

    Provided are in vitro and in vivo methods for determining whether a patient with Fabry disease will respond to treatment with a specific pharmacological chaperone.

    Patent expiration dates:

    • May 16, 2027
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Methods for treatment of Fabry disease
    Patent 9,987,263
    Issued: June 5, 2018
    Assignee(s): Amicus Therapeutics, Inc.

    Provided are in vitro and in vivo methods for determining whether a patient with Fabry disease will respond to treatment with a specific pharmacological chaperone.

    Patent expiration dates:

    • May 16, 2027
      ✓ 
      Patent use: THE TREATMENT OF FABRY PATIENTS
  • Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
    Patent 9,999,618
    Issued: June 19, 2018
    Assignee(s): Amicus Therapeutics, Inc.

    The present invention provides dosing regimens for administering pharmacological chaperones to a subject in need thereof. The dosing regimens can be used to treat disorders caused by improper protein misfolding, such as lysosomal storage disorders.

    Patent expiration dates:

    • April 28, 2028
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      Patent use: A METHOD OF REDUCING PODOCYTE GLOBOTRIAOSYLCERAMIDE (GL-3) IN A FABRY PATIENT BY ADMINISTERING MIGALASTAT
    • April 28, 2028
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      Patent use: A METHOD OF REDUCING LEFT VENTRICULAR MASS INDEX (LVMI) IN A FABRY PATIENT BY ADMINISTERING MIGALASTAT

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 10, 2023 - NEW CHEMICAL ENTITY
    • August 10, 2025 -

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.