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 forty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Migalastat hydrochloride has one hundred and forty-nine patent family members in twenty-seven countries.

Summary for migalastat hydrochloride

International Patents:	149
US Patents:	41
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	20
Patent Applications:	183
What excipients (inactive ingredients) are in migalastat hydrochloride?	migalastat hydrochloride excipients list
DailyMed Link:	migalastat hydrochloride at DailyMed

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

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	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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
Hong Kong	1129458	診斷和評估法布瑞氏病治療策略的檢測 (ASSAYS FOR DIAGNOSING AND EVALUATING TREATMENT OPTIONS FOR FABRY DISEASE)	See Plans and Pricing
Colombia	2018006358	Tratamiento de la enfermedad de fabry en pacientes no tratados y tratados previamente con ert	See Plans and Pricing
Luxembourg	93312		See Plans and Pricing
Taiwan	201733581	Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene	See Plans and Pricing
>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,C2787345	Lithuania	See Plans and Pricing	PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
2787345	C20160037 00206	Estonia	See Plans and Pricing	PRODUCT NAME: MIGALASTAAT;REG NO/DATE: EU/1/15/1082 31.05.2016
2787345	300843	Netherlands	See Plans and Pricing	PRODUCT NAME: MIGALASTAT OF EEN ZOUT DAARVAN, WAARONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/15/1082 20160531
2787345	122016000090	Germany	See Plans and Pricing	PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082/001 20160526
>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.