MIGALASTAT HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for migalastat hydrochloride and what is the scope of freedom to operate?

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		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
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ 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
Poland	2252313		⤷ Sign Up
Eurasian Patent Organization	201992869	СПОСОБЫ ЛЕЧЕНИЯ ПАЦИЕНТОВ С БОЛЕЗНЬЮ ФАБРИ, У КОТОРЫХ ИМЕЕТСЯ ПОЧЕЧНАЯ НЕДОСТАТОЧНОСТЬ	⤷ Sign Up
European Patent Office	2150254	SCHÉMAS POSOLOGIQUES POUR LE TRAITEMENT DE MALADIES DE STOCKAGE LYSOSOMAL EN UTILISANT DES CHAPERONS PHARMACOLOGIQUES (DOSING REGIMENS FOR THE TREATMENT OF LYSOSOMAL STORAGE DISEASES USING PHARMACOLOGICAL CHAPERONES)	⤷ Sign Up
Argentina	109103	TRATAMIENTO DE LA ENFERMEDAD DE FABRY EN PACIENTES NO TRATADOS Y TRATADOS PREVIAMENTE CON ERT	⤷ Sign Up
China	114159436	治疗在GLA基因中具有G9331A突变的患者的法布里病的方法 (Method of treating Fabry disease in patients having G9331A mutations in GLA gene)	⤷ Sign Up
Japan	6026268		⤷ 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	PA2016033	Lithuania	⤷ Sign Up	PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
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	SPC/GB16/067	United Kingdom	⤷ Sign Up	PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REGISTERED: UK EU/1/15/1082/001 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
2787345	93312	Luxembourg	⤷ Sign Up	PRODUCT NAME: MIGALASTAT OU UN SEL DE CELUI-CI , Y COMPRIS LE SEL DE CHLORHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1082 - GALAFOLD - MIGALASTAT
2787345	C20160037 00206	Estonia	⤷ Sign Up	PRODUCT NAME: MIGALASTAAT;REG NO/DATE: EU/1/15/1082 31.05.2016
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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