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Last Updated: May 27, 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 patent protection?

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

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

Summary for migalastat hydrochloride
International Patents:142
US Patents:29
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 31
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
>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 132016000116282 Italy See Plans and Pricing PRODUCT NAME: MIGALASTAT O UN SUO SALE, COMPRESO IL SALE CLORIDRATO(GALAFOLD); AUTHORISATION NUMBER(S) AND DATE(S): 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Johnson and Johnson
Moodys
AstraZeneca
Express Scripts

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