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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Last Updated: December 5, 2019

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MIGALASTAT HYDROCHLORIDE - Generic Drug Details

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What are the generic 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 Theraps Us and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Migalastat hydrochloride has ninety-nine patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for MIGALASTAT HYDROCHLORIDE
International Patents:99
US Patents:10
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 26
Clinical Trials: 16
Patent Applications: 3
DailyMed Link:MIGALASTAT HYDROCHLORIDE at DailyMed
Recent Clinical Trials for MIGALASTAT HYDROCHLORIDE

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

SponsorPhase
Amicus TherapeuticsPhase 1
Amicus TherapeuticsPhase 3
Amicus TherapeuticsPhase 2

See all MIGALASTAT HYDROCHLORIDE clinical trials

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-Deoxygalactonojirimycin HCl
1-Deoxynojirimycin hydrochloride
1,5-Dideoxy-1,5-imino-D-galactitol
1,5-dideoxy-1,5-imino-d-galactitol hydrochloride
108147-54-2
3,4,5-Piperidinetriol, 2-(hydroxymethyl)-, hydrochloride, (2R,3S,4R,5S)-
3,4,5-Piperidinetriol, 2-(hydroxymethyl)-, hydrochloride,[2R-(2a,3a,4a,5b)]-
75172-81-5
Amigal
BICL4269
CHEMBL2107355
CLY7M0XD20
CS-6380
D05031
Deoxygalactonojirimycin hydrochloride
DEOXYGALACTONOJIRIMYCIN,HYDROCHLORIDE
FT-0665818
Galafold (TN)
HY-14929A
Migalastat (hydrochloride)
Migalastat hydrochloride (JAN/USAN)
Migalastat Hydrochloride [USAN]
OR2365T
SB18975
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   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
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 MIGALASTAT HYDROCHLORIDE

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
2787345 C 2016 042 Romania   Start Trial PRODUCT NAME: MIGALASTAT SAU O SARE A ACESTUIA, INCLUSIV SAREACLORHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/15/1082; DATE OF NATIONAL AUTHORISATION: 20160526; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1082; DATE OF FIRST AUTHORISATION IN EEA: 20160526
2787345 PA2016033 Lithuania   Start Trial PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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