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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 208623


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NDA 208623 describes GALAFOLD, which is a drug marketed by Amicus Therap Us and is included in one NDA. It is available from one supplier. There are sixty-one patents protecting this drug. Additional details are available on the GALAFOLD profile page.

The generic ingredient in GALAFOLD is migalastat hydrochloride. One supplier is listed for this compound. Additional details are available on the migalastat hydrochloride profile page.
Summary for 208623
Tradename:GALAFOLD
Applicant:Amicus Therap Us
Ingredient:migalastat hydrochloride
Patents:61
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Suppliers and Packaging for NDA: 208623
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623 NDA Amicus Therapeutics US, LLC 71904-100 71904-100-01 14 BLISTER PACK in 1 CARTON (71904-100-01) / 1 CAPSULE in 1 BLISTER PACK

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
Patent:⤷  Sign UpPatent Expiration:Mar 15, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:THE TREATMENT OF FABRY PATIENTS
Patent:⤷  Sign UpPatent Expiration:May 30, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:THE TREATMENT OF FABRY PATIENTS

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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.