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Last Updated: March 9, 2021

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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 patent protection?

Migalastat hydrochloride is the generic ingredient in one branded drug marketed by Amicus Theraps Us and is included in one NDA. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for migalastat hydrochloride
International Patents:128
US Patents:21
Tradenames:1
Applicants:1
NDAs:1
Bulk Api Vendors: 26
Clinical Trials: 16
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 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
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 53/2016 Austria   Start Trial PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082 (MITTEILUNG) 20160531
2787345 C02787345/01 Switzerland   Start Trial PRODUCT NAME: MIGALASTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66108 28.10.2016
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 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 CR 2016 00055 Denmark   Start Trial PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531
2787345 C20160037 00206 Estonia   Start Trial PRODUCT NAME: MIGALASTAAT;REG NO/DATE: EU/1/15/1082 31.05.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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