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Last Updated: April 22, 2024

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

Migalastat hydrochloride has two hundred and twenty-one patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for migalastat hydrochloride
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for migalastat hydrochloride
Generic Entry Date for migalastat hydrochloride*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF ADULTS WITH A CONFIRMED DIAGNOSIS OF FABRY DISEASE AND AN AMENABLE GALACTOSIDASE ALPHA GENE (GLA) VARIANT BASED ON IN VITRO ASSAY DATA
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for migalastat hydrochloride

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

SponsorPhase
Genzyme, a Sanofi CompanyPhase 3
Amicus TherapeuticsPhase 1
Amicus TherapeuticsPhase 3

See all migalastat hydrochloride clinical trials

Paragraph IV (Patent) Challenges for MIGALASTAT HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GALAFOLD Capsules migalastat hydrochloride 123 mg 208623 3 2022-08-10

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 a Trial ⤷  Try a Trial ⤷  Try a Trial
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for migalastat hydrochloride

Country Patent Number Title Estimated Expiration
Argentina 122390 MÉTODOS PARA TRATAR LA ENFERMEDAD DE FABRY EN PACIENTES QUE TIENEN UNA MUTACIÓN EN EL GEN GLA ⤷  Try a Trial
Mexico 2009011473 REGIMENES DE DOSIFICACION PARA EL TRATAMIENTO DE ENFERMEDADES POR ALMACENAMIENTO LISOSOMAL QUE UTILIZAN CHAPERONAS FARMACOLOGICAS. (DOSING REGIMENS FOR THE TREATMENT OF LYSOSOMAL STORAGE DISEASES USING PHARMACOLOGICAL CHAPERONES.) ⤷  Try a Trial
Mexico 2022001623 METODOS PARA TRATAR LA ENFERMEDAD DE FABRY EN PACIENTES QUE TIENEN UNA MUTACION EN EL GEN GLA. (METHODS OF TREATING FABRY DISEASE IN PATIENTS HAVING A MUTATION IN THE GLA GENE.) ⤷  Try a Trial
Hungary E051377 ⤷  Try a Trial
China 115427040 治疗在GLA基因中具有突变的患者的法布里病的方法 (Method of treating Fabry disease in patients with mutations in GLA gene) ⤷  Try a Trial
Canada 3170718 METHODES DE TRAITEMENT DE LA MALADIE DE FABRY CHEZ LES PATIENTS PORTEURS D'UNE MUTATION DU GENE GLA (METHODS OF TREATING FABRY DISEASE IN PATIENTS HAVING A MUTATION IN THE GLA GENE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for migalastat hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2787345 PA2016033,C2787345 Lithuania ⤷  Try a Trial PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
2787345 C 2016 042 Romania ⤷  Try a 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 300843 Netherlands ⤷  Try a Trial PRODUCT NAME: MIGALASTAT OF EEN ZOUT DAARVAN, WAARONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/15/1082 20160531
2787345 93312 Luxembourg ⤷  Try a 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
2787345 2016/050 Ireland ⤷  Try a Trial PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT; REGISTRATION NO/DATE: EU/1/15/1082 20160526
2787345 53/2016 Austria ⤷  Try a Trial PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082 (MITTEILUNG) 20160531
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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