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Last Updated: May 4, 2024

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 twenty-one patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for migalastat hydrochloride

International Patents:	221
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^: ⤷ Try a Trial* 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	⤷ 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				⤷ 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				⤷ 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 migalastat hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Australia	2008245578	Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones	⤷ Try a Trial
Brazil	112022017881	MÉTODOS DE TRATAMENTO DA DOENÇA DE FABRY EM PACIENTES QUE TÊM UMA MUTAÇÃO NO GENE GLA	⤷ Try a Trial
Japan	2018138564	ファブリー病に対する治療の選択を診断し、評価するためのアッセイ (ASSAYS FOR DIAGNOSING AND EVALUATING TREATMENT OPTIONS FOR FABRY DISEASE)	⤷ Try a Trial
Denmark	2787345		⤷ Try a Trial
Canada	3065298	METHODES DE TRAITEMENT DE PATIENTS ATTEINTS DE LA MALADIE DE FABRY SOUFFRANT D'UNE INSUFFISANCE RENALE (METHODS OF TREATING FABRY PATIENTS HAVING RENAL IMPAIRMENT)	⤷ Try a Trial
South Korea	20190087673	ＧＬＡ 유전자에 Ｇ9331Ａ 돌연변이를 갖는 환자에서 파브리 질병의 치료 방법 (9331 METHODS OF TREATING FABRY DISEASE IN PATIENTS HAVING THE G9331A MUTATION IN THE GLA GENE)	⤷ Try a Trial
>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	⤷ Try a Trial	PRODUCT NAME: MIGALASTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1082 20160531
2787345	122016000090	Germany	⤷ Try a Trial	PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082/001 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	300843	Netherlands	⤷ Try a Trial	PRODUCT NAME: MIGALASTAT OF EEN ZOUT DAARVAN, WAARONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/15/1082 20160531
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	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
>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.