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Last Updated: February 25, 2024

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

Migalastat hydrochloride has two hundred and six patent family members in twenty-eight 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
>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
Croatia P20190143 ⤷  Try a Trial
Mexico 2019014410 METODOS DE TRATAMIENTO DE PACIENTES CON ENFERMEDAD DE FABRY QUE TIENEN INSUFICIENCIA RENAL. (METHODS OF TREATING FABRY PATIENTS HAVING RENAL IMPAIRMENT.) ⤷  Try a Trial
Taiwan 201733581 Methods of treating fabry disease in patients having the G9331A 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 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 1690052-4 Sweden ⤷  Try a Trial PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REG. NO/DATE: EU/1/15/1082 20160531
2787345 SPC/GB16/067 United Kingdom ⤷  Try a Trial PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REGISTERED: UK EU/1/15/1082/001 20160531
>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

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