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Last Updated: August 3, 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 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 twenty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for migalastat hydrochloride
International Patents:135
US Patents:25
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 29
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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amicus Theraps Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amicus Theraps 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 634 Finland ⤷  Try it Free
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 132016000116282 Italy ⤷  Try it Free PRODUCT NAME: MIGALASTAT O UN SUO SALE, COMPRESO IL SALE CLORIDRATO(GALAFOLD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1082, 20160531
2787345 C 2016 042 Romania ⤷  Try it Free 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 ⤷  Try it Free PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
2787345 122016000090 Germany ⤷  Try it Free PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082/001 20160526
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Johnson and Johnson
McKinsey
McKesson
Colorcon

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