Generic Galafold Availability
Last updated on Apr 10, 2025.
Galafold is a brand name of migalastat, approved by the FDA in the following formulation(s):
GALAFOLD (migalastat hydrochloride - capsule;oral)
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Manufacturer: AMICUS THERAP US
Approval date: August 10, 2018
Strength(s): EQ 123MG BASE [RLD]
Is there a generic version of Galafold available?
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.
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Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene
Patent 10,076,514
Issued: September 18, 2018
Inventor(s): Benjamin Elfrida
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✓
- March 15, 2037
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Methods of treating fabry patients having renal impairment
Patent 10,251,873
Issued: April 9, 2019
Inventor(s): Castelli Jeff & Benjamin Elfrida
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✓
- May 30, 2038
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Methods for treatment of Fabry disease
Patent 10,383,864
Issued: August 20, 2019
Inventor(s): Lockhart David J. & Castelli Jeff
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✓
- May 16, 2027
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Methods for treatment of fabry disease
Patent 10,406,143
Issued: September 10, 2019
Inventor(s): Lockhart David J. & Castelli Jeff
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✓
- May 16, 2027
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Methods of treating Fabry patients having renal impairment
Patent 10,471,053
Issued: November 12, 2019
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Patent 10,525,045
Issued: January 7, 2020
Inventor(s): Castelli Jeff & Lockhart David J.
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✓
- April 28, 2028
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Methods of treating Fabry patients having renal impairment
Patent 10,792,278
Issued: October 6, 2020
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 10,792,279
Issued: October 6, 2020
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 10,799,491
Issued: October 13, 2020
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating fabry patients having renal impairment
Patent 10,806,727
Issued: October 20, 2020
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Method to predict response to pharmacological chaperone treatment of diseases
Patent 10,813,921
Issued: October 27, 2020
Inventor(s): Benjamin Elfrida & Do Hung V. & Wu Xiaoyang & Flanagan John & Wustman Brandon Alan
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✓
- February 12, 2029
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Methods of treating Fabry patients having renal impairment
Patent 10,849,889
Issued: December 1, 2020
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 10,849,890
Issued: December 1, 2020
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 10,857,141
Issued: December 8, 2020
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 10,857,142
Issued: December 8, 2020
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating fabry patients having renal impairment
Patent 10,874,655
Issued: December 29, 2020
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 10,874,656
Issued: December 29, 2020
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 10,874,657
Issued: December 29, 2020
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Patent 10,925,866
Issued: February 23, 2021
Inventor(s): Castelli Jeff & Lockhart David J.
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✓
- April 28, 2028
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Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Patent 11,033,538
Issued: June 15, 2021
Inventor(s): Castelli Jeff & Lockhart David J.
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✓
- April 28, 2028
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Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene
Patent 11,234,972
Issued: February 1, 2022
Inventor(s): Benjamin Elfrida
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✓
- March 15, 2037
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Methods for treatment of Fabry disease
Patent 11,241,422
Issued: February 8, 2022
Inventor(s): Lockhart David J. & Castelli Jeff
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✓
- May 16, 2027
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Methods of treating Fabry patients having renal impairment
Patent 11,278,536
Issued: March 22, 2022
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,278,537
Issued: March 22, 2022
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,278,538
Issued: March 22, 2022
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,278,539
Issued: March 22, 2022
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,278,540
Issued: March 22, 2022
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,304,940
Issued: April 19, 2022
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,357,761
Issued: June 14, 2022
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,357,762
Issued: June 14, 2022
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating fabry patients having renal impairment
Patent 11,357,763
Issued: June 14, 2022
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,357,764
Issued: June 14, 2022
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,357,765
Issued: June 14, 2022
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Use of migalastat for treating Fabry disease in pregnant patients
Patent 11,357,784
Issued: June 14, 2022
Inventor(s): Barth Jay
Assignee(s): Amicus Therapeutics, Inc.Provided are methods of treating a patient diagnosed with Fabry disease. Certain methods treat a pregnant patient with a therapeutically effective dose of migalastat or a salt thereof. Other methods treat a patient of childbearing potential with a therapeutically effective dose of migalastat or a salt thereof. Also described are the successful outcomes of pregnancies during which the pregnant patient is treated with migalastat.
Patent expiration dates:
- February 6, 2039✓
- February 6, 2039
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Methods of treating Fabry patients having renal impairment
Patent 11,376,244
Issued: July 5, 2022
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating fabry patients having renal impairment
Patent 11,389,436
Issued: July 19, 2022
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,389,437
Issued: July 19, 2022
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,426,396
Issued: August 30, 2022
Inventor(s): Castelli Jeff & Benjamin Elfrida
Assignee(s): Amicus Therapeutics, Inc.Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,458,128
Issued: October 4, 2022
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,612,593
Issued: March 28, 2023
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,612,594
Issued: March 28, 2023
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,622,962
Issued: April 11, 2023
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- March 17, 2039✓
- March 17, 2039
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Methods of treating Fabry patients having renal impairment
Patent 11,633,387
Issued: April 25, 2023
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
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Methods of treating Fabry patients having renal impairment
Patent 11,633,388
Issued: April 25, 2023
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- March 25, 2039✓
- March 25, 2039
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Methods of treating Fabry patients having renal impairment
Patent 11,642,334
Issued: May 9, 2023
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- February 20, 2039✓
- February 20, 2039
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Methods of treating Fabry patients having renal impairment
Patent 11,666,564
Issued: June 6, 2023
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
-
Methods of treating Fabry patients having renal impairment
Patent 11,786,516
Issued: October 17, 2023
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
-
Methods of treating Fabry patients having renal impairment
Patent 11,813,255
Issued: November 14, 2023
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
-
Methods of treating Fabry patients having renal impairment
Patent 11,826,360
Issued: November 28, 2023
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- February 16, 2039✓
- February 16, 2039
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Methods of treating Fabry disease in patients having a mutation in the GLA gene
Patent 11,833,164
Issued: December 5, 2023
Inventor(s): Benjamin; Elfrida et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)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 mutation in 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:
- January 11, 2042✓
- January 11, 2042
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Methods of treating Fabry patients having renal impairment
Patent 11,903,938
Issued: February 20, 2024
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- August 17, 2038✓✓
- August 17, 2038
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Methods of treating Fabry patients having renal impairment
Patent 12,042,488
Issued: July 23, 2024
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
-
Methods of treating Fabry patients having renal impairment
Patent 12,042,489
Issued: July 23, 2024
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓✓
- May 30, 2038
-
Methods of treating Fabry patients having renal impairment
Patent 12,042,490
Issued: July 23, 2024
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓
- May 30, 2038
-
Methods of treating Fabry patients having renal impairment
Patent 12,109,205
Issued: October 8, 2024
Inventor(s): Castelli; Jeff et al.
Assignee(s): Amicus Therapeutics, Inc. (Philadelphia, PA)Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Patent expiration dates:
- May 30, 2038✓✓
- May 30, 2038
-
Method to predict response to pharmacological chaperone treatment of diseases
Patent 8,592,362
Issued: November 26, 2013
Inventor(s): Benjamin Elfrida & Do Hung V. & Wu Xiaoyang & Flanagan John & Wustman Brandon
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✓✓
- February 12, 2029
-
Methods for treatment of Fabry disease
Patent 9,000,011
Issued: April 7, 2015
Inventor(s): Lockhart David & Castelli Jeff
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✓
- May 16, 2027
-
Method to predict response to pharmacological chaperone treatment of diseases
Patent 9,095,584
Issued: August 4, 2015
Inventor(s): Benjamin Elfrida & Do Hung V. & Wu Xiaoyang & Flanagan John & Wustman Brandon
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✓
- February 12, 2029
-
Methods for treatment of Fabry disease
Patent 9,480,682
Issued: November 1, 2016
Inventor(s): Lockhart David & Castelli Jeff
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✓
- May 16, 2027
-
Methods for treatment of Fabry disease
Patent 9,987,263
Issued: June 5, 2018
Inventor(s): Lockhart David J. & Castelli Jeff
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✓
- May 16, 2027
-
Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Patent 9,999,618
Issued: June 19, 2018
Inventor(s): Castelli Jeff & Lockhart David J.
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✓
- April 28, 2028✓
- April 28, 2028
-
Method to predict response to pharmacological chaperone treatment of diseases
Patent RE48608
Issued: June 29, 2021
Inventor(s): Benjamin Elfrida & Do Hung V. & Flanagan John & Wu Xiaoyang & Wustman Brandon
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:
- October 20, 2031✓
- October 20, 2031
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, 2025 - INDICATED FOR THE TREATMENT OF ADULTS WITH A CONFIRMED DIAGNOSIS OF FABRY DISEASE AND AN AMENABLE GALACTOSIDASE ALPHA GENE (GLA) VARIANT BASED ON IN VITRO ASSAY DATA
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| 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. |
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