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Last Updated: May 21, 2022

GALAFOLD Drug Patent Profile


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When do Galafold patents expire, and when can generic versions of Galafold launch?

Galafold is a drug marketed by Amicus Therap Us and is included in one NDA. There are twenty-nine patents protecting this drug.

This drug has one hundred and forty-one patent family members in twenty-seven countries.

The generic ingredient in GALAFOLD is migalastat hydrochloride. Additional details are available on the migalastat hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Galafold

Galafold will be eligible for patent challenges on August 10, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

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Summary for GALAFOLD
International Patents:141
US Patents:29
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 17
Clinical Trials: 10
Patent Applications: 281
What excipients (inactive ingredients) are in GALAFOLD?GALAFOLD excipients list
DailyMed Link:GALAFOLD at DailyMed
Drug patent expirations by year for GALAFOLD
DrugPatentWatch® Estimated Generic Entry Opportunity 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

US Patents and Regulatory Information for GALAFOLD

GALAFOLD is protected by thirty US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GALAFOLD is See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating fabry patients having renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods for treatment of Fabry disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods for treatment of fabry disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating fabry patients having renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Method to predict response to pharmacological chaperone treatment of diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating fabry patients having renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods of treating Fabry patients having renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Method to predict response to pharmacological chaperone treatment of diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods for treatment of Fabry disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Method to predict response to pharmacological chaperone treatment of diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods for treatment of Fabry disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods for treatment of Fabry disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF FABRY PATIENTS

FDA Regulatory Exclusivity protecting GALAFOLD

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Hungary E027569 See Plans and Pricing
Portugal 2946785 See Plans and Pricing
Chile 2019003496 Métodos de tratamiento de pacientes con enfermedad de fabry que tienen insuficiencia renal. See Plans and Pricing
Hungary S1600048 See Plans and Pricing
Brazil 112019025083 métodos de tratamento de pacientes portadores de fabry com insuficiência renal See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GALAFOLD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2787345 122016000090 Germany See Plans and Pricing PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082/001 20160526
2787345 C 2016 042 Romania See Plans and Pricing 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 300843 Netherlands See Plans and Pricing PRODUCT NAME: MIGALASTAT OF EEN ZOUT DAARVAN, WAARONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/15/1082 20160531
2787345 CA 2016 00055 Denmark See Plans and Pricing PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531
2787345 CR 2016 00055 Denmark See Plans and Pricing PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 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.