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Last Updated: December 7, 2021

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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 Therap Us and is included in one NDA. There are twenty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Migalastat hydrochloride has one hundred and thirty-eight patent family members in twenty-seven countries.

Summary for MIGALASTAT HYDROCHLORIDE
International Patents:138
US Patents:27
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 30
Clinical Trials: 19
Patent Applications: 3
What excipients (inactive ingredients) are in MIGALASTAT HYDROCHLORIDE?MIGALASTAT HYDROCHLORIDE excipients list
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

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 Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 CR 2016 00055 Denmark ⤷  Try it Free PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531
2787345 PA2016033,C2787345 Lithuania ⤷  Try it Free PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
2787345 268 5025-2016 Slovakia ⤷  Try it Free PRODUCT NAME: MIGALASTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1082 20160531
2787345 16C1014 France ⤷  Try it Free PRODUCT NAME: MIGALASTAT OU UN SEL DE CELUI-CI,NOTAMENT LE CHLORHYDRATE; REGISTRATION NO/DATE: EU1/15/1082 20160531
2787345 300843 Netherlands ⤷  Try it Free PRODUCT NAME: MIGALASTAT OF EEN ZOUT DAARVAN, WAARONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/15/1082 20160531
2787345 93312 Luxembourg ⤷  Try it Free 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
2787345 2016/050 Ireland ⤷  Try it Free PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT; 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:

Johnson and Johnson
Baxter
Merck
Mallinckrodt
Harvard Business School
McKesson

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 verification 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.