Migalastat hydrochloride - Generic Drug Details

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What are the generic drug sources for migalastat hydrochloride and what is the scope of patent protection?

Migalastat hydrochloride is the generic ingredient in one branded drug marketed by Amicus Therap Us and is included in one NDA. There are fifty-eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Migalastat hydrochloride has two hundred and thirty-three patent family members in thirty countries.

One supplier is listed for this compound.

Summary for migalastat hydrochloride

International Patents:	233
US Patents:	58
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	20
Patent Applications:	163
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for migalastat hydrochloride
What excipients (inactive ingredients) are in migalastat hydrochloride?	migalastat hydrochloride excipients list
DailyMed Link:	migalastat hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for migalastat hydrochloride

Generic Entry Date for migalastat hydrochloride^: ⤷ Sign Up* 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 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 migalastat hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Genzyme, a Sanofi Company	Phase 3
Amicus Therapeutics	Phase 1
Amicus Therapeutics	Phase 3

See all migalastat hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for migalastat hydrochloride

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 MIGALASTAT HYDROCHLORIDE

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 migalastat hydrochloride

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Glossary

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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3470077	PROCÉDÉ DE PRÉDICTION DE LA RÉACTION À UN TRAITEMENT DE MALADIES PAR CHAPERONS PHARMACOLOGIQUES (METHOD TO PREDICT RESPONSE TO PHARMACOLOGICAL CHAPERONE TREATMENT OF DISEASES)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2010123369		⤷ Sign Up
Mexico	2018007669	TRATAMIENTO DE LA ENFERMEDAD DE FABRY EN PACIENTES NO TRATADOS Y TRATADOS PREVIAMENTE CON ERT. (TREATMENT OF FABRY DISEASE IN ERT-NAÃ VE AND ERT-EXPERIENCED PATIENTS.)	⤷ Sign Up
Australia	2020327019	Methods of treating Fabry disease in patients having a mutation in the GLA gene	⤷ Sign Up
European Patent Office	3851105	MÉTHODES DE TRAITEMENT DE LA MALADIE DE FABRY CHEZ LES PATIENTS PORTEURS D'UNE MUTATION DU GÈNE GLA (METHODS OF TREATING FABRY DISEASE IN PATIENTS HAVING A MUTATION IN THE GLA GENE)	⤷ Sign Up
Japan	2009537149		⤷ Sign Up
Japan	2023109807	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 TO PREDICT RESPONSE TO PHARMACOLOGICAL CHAPERONE TREATMENT OF DISEASES)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for migalastat hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2787345	268 5025-2016	Slovakia	⤷ Sign Up	PRODUCT NAME: MIGALASTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1082 20160531
2787345	2016/050	Ireland	⤷ Sign Up	PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT; REGISTRATION NO/DATE: EU/1/15/1082 20160526
2787345	634	Finland	⤷ Sign Up
2787345	CR 2016 00055	Denmark	⤷ Sign Up	PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531
2787345	1690052-4	Sweden	⤷ Sign Up	PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REG. NO/DATE: EU/1/15/1082 20160531
2787345	CA 2016 00055	Denmark	⤷ Sign Up	PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531
2787345	16C1014	France	⤷ Sign Up	PRODUCT NAME: MIGALASTAT OU UN SEL DE CELUI-CI,NOTAMENT LE CHLORHYDRATE; REGISTRATION NO/DATE: EU1/15/1082 20160531
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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