Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Baxter
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Medtronic
Merck

Last Updated: December 5, 2019

DrugPatentWatch Database Preview

GALAFOLD Drug Profile

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Which patents cover Galafold, 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 ten patents protecting this drug.

This drug has ninety-nine patent family members in twenty-five 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:99
US Patents:10
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 13
Clinical Trials: 2
Patent Applications: 45
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.

Recent Clinical Trials for GALAFOLD

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Amicus TherapeuticsPhase 3

See all GALAFOLD clinical trials

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-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
3,4,5-Piperidinetriol, 2-(hydroxymethyl)-, (2R,3S,4R,5S)-
3,4,5-Piperidinetriol,2-(hydroxymethyl)-, (2R,3S,4R,5S)-
AC1L41WN
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
D10359
DB05018
DDIG
DEOXYGALACTONOJIRIMYCIN
GR-181413A
GR181413A
GTPL10200
LS-186039
LXBIFEVIBLOUGU-DPYQTVNSSA-N
Migalastat
Migalastat (USAN/INN)
Migalastat [USAN:INN]
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   Start Trial   Start Trial   Start Trial
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for GALAFOLD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2787345 268 5025-2016 Slovakia   Start Trial PRODUCT NAME: MIGALASTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1082 20160531
2787345 2016/050 Ireland   Start Trial PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT; REGISTRATION NO/DATE: EU/1/15/1082 20160526
2787345 C20160037 00206 Estonia   Start Trial PRODUCT NAME: MIGALASTAAT;REG NO/DATE: EU/1/15/1082 31.05.2016
2787345 CA 2016 00055 Denmark   Start Trial PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
Boehringer Ingelheim
Johnson and Johnson
Mallinckrodt
Medtronic

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