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Generated: May 22, 2019

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galafold Drug Profile

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When do Galafold patents expire, and what generic alternatives are available?

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 eighty-six patent family members in twenty-four 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:86
US Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 15
Clinical Trials: 2
Patent Applications: 42
Prior Art and Litigation SupportOrder Prior Art and Litigation support for galafold
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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Supplementary Protection Certificates for galafold

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2787345 CR 2016 00055 Denmark ➤ Sign Up PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531
2787345 PA2016033,C2787345 Lithuania ➤ Sign Up PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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