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Migalastat hydrochloride - Generic Drug Details

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

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

Migalastat hydrochloride has sixty-three patent family members in nineteen countries.

One supplier is listed for this compound.

Summary for migalastat hydrochloride

International Patents:	63
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	25
Clinical Trials:	14
Patent Applications:	3
DailyMed Link:	migalastat hydrochloride at DailyMed

Synonyms for migalastat hydrochloride

(+)-(2R,3S,4R,5S)-2-(Hydroxymethyl)piperidine-3,4,5-triol hydrochloride

(2R,3S,4R,5S)-2-(hydroxymethyl)-3,4,5-Piperidinetriol hydrochloride

(2R,3S,4R,5S)-2-(Hydroxymethyl)piperidine-3,4,5-triol hydrochloride

1-Deoxy-L-altronojirimycin Hydrochloride

1-Deoxygalactonojirimycin HCl

1-Deoxynojirimycin hydrochloride

1,5-Dideoxy-1,5-imino-D-galactitol

1,5-dideoxy-1,5-imino-d-galactitol hydrochloride

3,4,5-Piperidinetriol, 2-(hydroxymethyl)-, hydrochloride, (2R,3S,4R,5S)-

75172-81-5

AKOS027384247

Amigal

BICL4269

CHEMBL2107355

CLY7M0XD20

CS-6380

D05031

Deoxygalactonojirimycin hydrochloride

Deoxygalactonojirimycin, Hydrochloride

DEOXYGALACTONOJIRIMYCIN,HYDROCHLORIDE

FT-0665818

Galafold (TN)

HY-14929A

KB-270793

Migalastat (hydrochloride)

migalastat HCl

Migalastat hydrochloride (JAN/USAN)

Migalastat Hydrochloride [USAN]

MolPort-039-016-078

OR2365T

SCHEMBL3802618

UNII-CLY7M0XD20

W-203722

ZX-AT009958

US Patents and Regulatory Information for migalastat hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amicus Theraps Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes
Amicus Theraps Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes
Amicus Theraps Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes
Amicus Theraps Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes

International Patents for migalastat hydrochloride

Country	Document Number	Estimated Expiration
Japan	2011514152
Australia	2007253900
European Patent Office	2252313
Japan	5844045

Supplementary Protection Certificates for migalastat hydrochloride

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016033,C2787345	Lithuania		PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
0843	Netherlands		PRODUCT NAME: MIGALASTAT OF EEN ZOUT DAARVAN, WAARONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/15/1082 20160531
C1014	France		PRODUCT NAME: MIGALASTAT OU UN SEL DE CELUI-CI,NOTAMENT LE CHLORHYDRATE; REGISTRATION NO/DATE: EU1/15/1082 20160531
2016 00055	Denmark		PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531