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GALAFOLD Drug Patent Profile

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 sixty-one patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-nine 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

Summary for GALAFOLD

International Patents:	239
US Patents:	61
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	10
Patent Applications:	75
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GALAFOLD
What excipients (inactive ingredients) are in GALAFOLD?	GALAFOLD excipients list
DailyMed Link:	GALAFOLD at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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:

208623

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

Sponsor	Phase
Amicus Therapeutics	Phase 3
Amicus Therapeutics	Phase 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 sixty-two US patents and one FDA Regulatory Exclusivity.

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

FDA Regulatory Exclusivity protecting GALAFOLD

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
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes				Y
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes				Y

International Patents for GALAFOLD

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20240017112	신장 손상을 갖는 파브리 환자를 치료하는 방법 (METHODS OF TREATING FABRY PATIENTS HAVING RENAL IMPAIRMENT)
Canada	3224537	UTILISATION DU MIGALASTAT DANS LE TRAITEMENT DES PATIENTS ATTEINTS DE LAMALADIE DE FABRY PRESENTANT UNE DEFICIENCE RENALE (USE OF MIGALASTAT IN THE TREATMENT OF FABRY PATIENTS HAVING RENAL IMPAIRMENT)
Israel	264301	טיפול במחלת פברי בחולים שהתנסו ב- ert-naive ו- ert (Treatment of fabry disease in ert-naive and ert-experienced patients)
European Patent Office	3630114	MÉTHODES DE TRAITEMENT DE PATIENTS ATTEINTS DE LA MALADIE DE FABRY SOUFFRANT D'UNE INSUFFISANCE RÉNALE (METHODS OF TREATING FABRY PATIENTS HAVING RENAL IMPAIRMENT)
Croatia	P20240061
Mexico	351004	ENSAYOS PARA DIAGNOSTICAR Y EVALUAR OPCIONES DE TRATAMIENTO PARA ENFERMEDAD DE FABRY. (ASSAYS FOR DIAGNOSING AND EVALUATING TREATMENT OPTIONS FOR FABRY DISEASE.)
Portugal	3630114

Supplementary Protection Certificates for GALAFOLD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2787345	53/2016	Austria		PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082 (MITTEILUNG) 20160531
2787345	C 2016 042	Romania		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	16C1014	France		PRODUCT NAME: MIGALASTAT OU UN SEL DE CELUI-CI,NOTAMENT LE CHLORHYDRATE; REGISTRATION NO/DATE: EU1/15/1082 20160531
2787345	634	Finland
2787345	300843	Netherlands		PRODUCT NAME: MIGALASTAT OF EEN ZOUT DAARVAN, WAARONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/15/1082 20160531
2787345	C02787345/01	Switzerland		PRODUCT NAME: MIGALASTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66108 28.10.2016
2787345	2016/050	Ireland		PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT; REGISTRATION NO/DATE: EU/1/15/1082 20160526