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Last Updated: August 17, 2022

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

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

Summary for migalastat hydrochloride
International Patents:149
US Patents:41
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 34
Clinical Trials: 20
Patent Applications: 183
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
Genzyme, a Sanofi CompanyPhase 3
Amicus TherapeuticsPhase 1
Amicus TherapeuticsPhase 3

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Hong Kong 1129458 診斷和評估法布瑞氏病治療策略的檢測 (ASSAYS FOR DIAGNOSING AND EVALUATING TREATMENT OPTIONS FOR FABRY DISEASE) See Plans and Pricing
Colombia 2018006358 Tratamiento de la enfermedad de fabry en pacientes no tratados y tratados previamente con ert See Plans and Pricing
Luxembourg 93312 See Plans and Pricing
Taiwan 201733581 Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
2787345 C20160037 00206 Estonia See Plans and Pricing PRODUCT NAME: MIGALASTAAT;REG NO/DATE: EU/1/15/1082 31.05.2016
2787345 300843 Netherlands See Plans and Pricing PRODUCT NAME: MIGALASTAT OF EEN ZOUT DAARVAN, WAARONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/15/1082 20160531
2787345 122016000090 Germany See Plans and Pricing 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

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.