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Last Updated: June 12, 2024

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GALAFOLD Drug Patent Profile


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When do Galafold patents expire, and what generic alternatives are available?

Galafold is a drug marketed by Amicus Therap Us and is included in one NDA. There are fifty-eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-three patent family members in thirty countries.

The generic ingredient in GALAFOLD is migalastat hydrochloride. One supplier is listed for this compound. Additional details are available on the migalastat hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Galafold

Galafold was eligible for patent challenges on August 10, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 10, 2025. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for GALAFOLD
Drug patent expirations by year for GALAFOLD
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GALAFOLD
Generic Entry Date for GALAFOLD*:
Constraining patent/regulatory exclusivity:
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
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GALAFOLD

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Amicus TherapeuticsPhase 3
Amicus TherapeuticsPhase 2

See all GALAFOLD clinical trials

Paragraph IV (Patent) Challenges for GALAFOLD
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GALAFOLD Capsules migalastat hydrochloride 123 mg 208623 3 2022-08-10

US Patents and Regulatory Information for GALAFOLD

GALAFOLD is protected by fifty-nine US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GALAFOLD is ⤷  Sign Up.

This potential generic entry date is based on 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting GALAFOLD

Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods for treatment of Fabry disease
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods for treatment of fabry disease
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Method to predict response to pharmacological chaperone treatment of diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Use of migalastat for treating Fabry disease in pregnant patients
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods of treating fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Method to predict response to pharmacological chaperone treatment of diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods for treatment of Fabry disease
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Method to predict response to pharmacological chaperone treatment of diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods for treatment of Fabry disease
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods for treatment of Fabry disease
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF REDUCING PODOCYTE GLOBOTRIAOSYLCERAMIDE (GL-3) IN A FABRY PATIENT BY ADMINISTERING MIGALASTAT

Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF REDUCING LEFT VENTRICULAR MASS INDEX (LVMI) IN A FABRY PATIENT BY ADMINISTERING MIGALASTAT

Method to predict response to pharmacological chaperone treatment of diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF FABRY PATIENTS

FDA Regulatory Exclusivity protecting GALAFOLD

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
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for GALAFOLD

See the table below for patents covering GALAFOLD around the world.

Country Patent Number Title Estimated Expiration
Taiwan 201900165 Methods of treating fabry patients having renal impairment ⤷  Sign Up
Mexico 2009011473 REGIMENES DE DOSIFICACION PARA EL TRATAMIENTO DE ENFERMEDADES POR ALMACENAMIENTO LISOSOMAL QUE UTILIZAN CHAPERONAS FARMACOLOGICAS. (DOSING REGIMENS FOR THE TREATMENT OF LYSOSOMAL STORAGE DISEASES USING PHARMACOLOGICAL CHAPERONES.) ⤷  Sign Up
Chile 2019003496 Métodos de tratamiento de pacientes con enfermedad de fabry que tienen insuficiencia renal. ⤷  Sign Up
Japan 6752270 ⤷  Sign Up
Poland 3630114 ⤷  Sign Up
Chile 2022002423 Métodos para tratar la enfermedad de fabry ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GALAFOLD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2787345 C20160037 00206 Estonia ⤷  Sign Up PRODUCT NAME: MIGALASTAAT;REG NO/DATE: EU/1/15/1082 31.05.2016
2787345 634 Finland ⤷  Sign Up
2787345 53/2016 Austria ⤷  Sign Up PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082 (MITTEILUNG) 20160531
2787345 C 2016 042 Romania ⤷  Sign Up PRODUCT NAME: MIGALASTAT SAU O SARE A ACESTUIA, INCLUSIV SAREACLORHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/15/1082; DATE OF NATIONAL AUTHORISATION: 20160526; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1082; DATE OF FIRST AUTHORISATION IN EEA: 20160526
2787345 268 5025-2016 Slovakia ⤷  Sign Up PRODUCT NAME: MIGALASTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1082 20160531
2787345 SPC/GB16/067 United Kingdom ⤷  Sign Up PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REGISTERED: UK EU/1/15/1082/001 20160531
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.