galafold Drug Patent Profile

Which patents cover Galafold, 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-nine 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

Summary for galafold

International Patents:	159
US Patents:	46
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	10
Patent Applications:	350
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 Generic Entry Opportunity 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

Anatomical Therapeutic Chemical (ATC) Classes for galafold

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

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.

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

International Patents for galafold

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

Country	Patent Number	Title	Estimated Expiration
Australia	2017298376	Treatment of Fabry disease in ERT-naive and ERT-experienced patients
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)
Croatia	P20201827
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)
Poland	2533050

Supplementary Protection Certificates for galafold

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2787345	CA 2016 00055	Denmark		PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 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	1690052-4	Sweden		PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REG. NO/DATE: EU/1/15/1082 20160531
2787345	C02787345/01	Switzerland		PRODUCT NAME: MIGALASTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66108 28.10.2016
2787345	PA2016033	Lithuania		PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526