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Last Updated: July 13, 2020

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Details for New Drug Application (NDA): 208623


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NDA 208623 describes GALAFOLD, which is a drug marketed by Amicus Theraps Us and is included in one NDA. There are twelve patents protecting this drug. Additional details are available on the GALAFOLD profile page.

The generic ingredient in GALAFOLD is migalastat hydrochloride. Additional details are available on the migalastat hydrochloride profile page.
Summary for 208623
Tradename:GALAFOLD
Applicant:Amicus Theraps Us
Ingredient:migalastat hydrochloride
Patents:12
Generic Entry Opportunity Date for 208623
Generic Entry Date for 208623*:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 123MG BASE
Approval Date:Aug 10, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 10, 2025
Regulatory Exclusivity Use: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
Regulatory Exclusivity Expiration:Aug 10, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Mar 15, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:THE TREATMENT OF FABRY PATIENTS

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