Details for New Drug Application (NDA): 208623
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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: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 123MG BASE | ||||
Approval Date: | Aug 10, 2018 | TE: | 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 Up | Patent Expiration: | Mar 15, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | THE TREATMENT OF FABRY PATIENTS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 30, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | THE TREATMENT OF FABRY PATIENTS |
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