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 forty-six 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.
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: | 46 |
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 | ||||||||
| Regulatory Exclusivity Expiration: | Aug 10, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 15, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | THE TREATMENT OF FABRY PATIENTS | ||||||||
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