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Last Updated: January 31, 2023

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 forty-six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-eight patent family members in twenty-seven 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 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

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 forty-seven 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

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

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

Methods of treating Fabry patients having renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Use of migalastat for treating Fabry disease in pregnant patients
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

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


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 Y 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
Lithuania 3470077 See Plans and Pricing
Canada 3031249 TRAITEMENT DE LA MALADIE DE FABRY CHEZ DES PATIENTS SOUMIS A UNE THERAPIE ENZYMATIQUE SUBSTITUTIVE (ERT) ET CHEZ DES PATIENTS NON SOUMIS A UNE ERT (TREATMENT OF FABRY DISEASE IN ERT-NAIVE AND ERT-EXPERIENCED PATIENTS) See Plans and Pricing
Japan 2020203886 腎機能障害を有するファブリー患者の治療方法 (METHODS OF TREATING FABRY PATIENTS HAVING RENAL IMPAIRMENT) See Plans and Pricing
Japan 2016163571 疾病の薬理シャペロン治療に対する応答性を予測する方法 (METHOD OF PREDICTING RESPONSE TO PHARMACOLOGICAL CHAPERONE TREATMENT OF DISEASES) See Plans and Pricing
Taiwan 202140000 Methods of treating Fabry patients having renal impairment 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 268 5025-2016 Slovakia See Plans and Pricing PRODUCT NAME: MIGALASTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1082 20160531
2787345 C20160037 00206 Estonia See Plans and Pricing PRODUCT NAME: MIGALASTAAT;REG NO/DATE: EU/1/15/1082 31.05.2016
2787345 PA2016033 Lithuania See Plans and Pricing PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
2787345 PA2016033,C2787345 Lithuania See Plans and Pricing PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
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
>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.