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:

Mallinckrodt
Moodys
AstraZeneca
Harvard Business School
McKesson
Johnson and Johnson

Last Updated: October 19, 2019

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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 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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for migalastat hydrochloride
International Patents:96
US Patents:9
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

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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
>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 122016000090 Germany   Start Trial PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082/001 20160526
2787345 PA2016033,C2787345 Lithuania   Start Trial PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
2787345 93312 Luxembourg   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
McKinsey
Dow
AstraZeneca
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.