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Generated: December 11, 2018

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GALAFOLD Drug Profile

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When do Galafold patents expire, and when can generic versions of Galafold launch?

Galafold is a drug marketed by Amicus Theraps Us and is included in one NDA. There are seven patents protecting this drug.

This drug has sixty-three patent family members in nineteen countries.

The generic ingredient in GALAFOLD is migalastat hydrochloride. One supplier is listed for this compound. Additional details are available on the migalastat hydrochloride profile page.

Summary for GALAFOLD
International Patents:63
US Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 13
Clinical Trials: 2
DailyMed Link:GALAFOLD at DailyMed
Drug patent expirations by year for GALAFOLD
Generic Entry Opportunity Date for GALAFOLD
Generic Entry Date for GALAFOLD*:
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
NDA:
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.

Synonyms for GALAFOLD
(2R,3S,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol
(2R,3S,4R,5S)-2-Hydroxymethyl-piperidine-3,4,5-triol
1-deoxygalactonojirimycin
1-Deoxygalactonojirimycin Hydrochloride
1-Deoxygalactostatin
1,5-Dideoxy-1,5-imino-D-galactitol
1,5-Dideoxy-1,5-iminogalactitol
1,5-didesoxy-l,5-imino-D-galactitol
108147-54-2
2-(Hydroxymethyl)-3,4,5-piperidinetriol hydrochloride
3,4,5-Piperidinetriol, 2-(hydroxymethyl)-, (2R,3S,4R,5S)-
3,4,5-Piperidinetriol,2-(hydroxymethyl)-, (2R,3S,4R,5S)-
AC1L41WN
AKOS027324390
Amigal
BDBM50163440
C4XNY919FW
CHEBI:135923
CHEMBL110458
CTK4A5883
D-Galactitol, 1,5-dideoxy-1,5-imino
D-Galactitol, 1,5-dideoxy-1,5-imino-
D-galacto-1-Deoxynojirimycin
D0A0UR
D0MU9L
D10359
DB05018
DDIG
DEOXYGALACTONOJIRIMYCIN
GR181413A
LS-186039
LXBIFEVIBLOUGU-DPYQTVNSSA-N
Migalastat
Migalastat (USAN/INN)
Migalastat [USAN:INN]
migalastat HCl
NCGC00025085-01
NSC658776
SCHEMBL1479364
Tocris-1258
UNII-C4XNY919FW
ZINC1636704

US Patents and Regulatory Information for GALAFOLD

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

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International Patents for GALAFOLD

Supplementary Protection Certificates for GALAFOLD

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0843 Netherlands ➤ Try a Free Trial PRODUCT NAME: MIGALASTAT OF EEN ZOUT DAARVAN, WAARONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/15/1082 20160531
8 5025-2016 Slovakia ➤ Try a Free Trial PRODUCT NAME: MIGALASTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1082 20160531
C1014 France ➤ Try a Free Trial PRODUCT NAME: MIGALASTAT OU UN SEL DE CELUI-CI,NOTAMENT LE CHLORHYDRATE; REGISTRATION NO/DATE: EU1/15/1082 20160531
312 Luxembourg ➤ Try a Free Trial 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
16/050 Ireland ➤ Try a Free Trial PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT; REGISTRATION NO/DATE: EU/1/15/1082 20160526
2016000090 Germany ➤ Try a Free Trial PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082/001 20160526
0160037 00206 Estonia ➤ Try a Free Trial PRODUCT NAME: MIGALASTAAT;REG NO/DATE: EU/1/15/1082 31.05.2016
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Covington
Citi
Queensland Health
McKesson
Daiichi Sankyo
Deloitte
Medtronic
Moodys

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