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Last Updated: April 13, 2024

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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 fifty-eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twenty-one patent family members in twenty-nine 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 ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS

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

Methods for treatment of Fabry disease
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods for treatment of fabry disease
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS

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

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

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

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

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

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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

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

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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

Methods of treating Fabry patients having renal impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS

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

Methods for treatment of Fabry disease
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS

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

Methods for treatment of Fabry disease
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS

Methods for treatment of Fabry disease
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF FABRY PATIENTS

Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 ⤷  Try a Trial
Hungary E051377 ⤷  Try a Trial
South Korea 20240017111 신장 손상을 갖는 파브리 환자를 치료하는 방법 (METHODS OF TREATING FABRY PATIENTS HAVING RENAL IMPAIRMENT) ⤷  Try a Trial
European Patent Office 4324522 MÉTHODES DE TRAITEMENT DE PATIENTS ATTEINTS DE LA MALADIE DE FABRY SOUFFRANT D'UNE INSUFFISANCE RÉNALE (METHODS OF TREATING FABRY PATIENTS HAVING RENAL IMPAIRMENT) ⤷  Try a Trial
Argentina 122298 MÉTODOS PARA TRATAR LA ENFERMEDAD DE FABRY EN PACIENTES QUE TIENEN UNA MUTACIÓN EN EL GEN GLA ⤷  Try a Trial
Hungary E042882 ⤷  Try a Trial
European Patent Office 2252313 MÉTHODE DE PRÉDICTION DE LA RÉPONSE DE CERTAINES MALADIES À UN TRAITEMENT PHARMACOLOGIQUE À BASE DE CHAPERONE MOLÉCULAIRE (METHOD TO PREDICT RESPONSE TO PHARMACOLOGICAL CHAPERONE TREATMENT OF DISEASES) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GALAFOLD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2787345 132016000116282 Italy ⤷  Try a Trial PRODUCT NAME: MIGALASTAT O UN SUO SALE, COMPRESO IL SALE CLORIDRATO(GALAFOLD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1082, 20160531
2787345 C20160037 00206 Estonia ⤷  Try a Trial PRODUCT NAME: MIGALASTAAT;REG NO/DATE: EU/1/15/1082 31.05.2016
2787345 C02787345/01 Switzerland ⤷  Try a Trial PRODUCT NAME: MIGALASTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66108 28.10.2016
2787345 PA2016033,C2787345 Lithuania ⤷  Try a Trial PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
2787345 SPC/GB16/067 United Kingdom ⤷  Try a Trial PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REGISTERED: UK EU/1/15/1082/001 20160531
2787345 53/2016 Austria ⤷  Try a Trial PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082 (MITTEILUNG) 20160531
2787345 CR 2016 00055 Denmark ⤷  Try a Trial 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.