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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 214927


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NDA 214927 describes MIPLYFFA, which is a drug marketed by Zevra Denmark and is included in one NDA. It is available from one supplier. Additional details are available on the MIPLYFFA profile page.

The generic ingredient in MIPLYFFA is arimoclomol citrate. One supplier is listed for this compound. Additional details are available on the arimoclomol citrate profile page.
Summary for 214927
Tradename:MIPLYFFA
Applicant:Zevra Denmark
Ingredient:arimoclomol citrate
Patents:0
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214927
Generic Entry Date for 214927*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
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: 214927
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIPLYFFA arimoclomol citrate CAPSULE;ORAL 214927 NDA Acer Therapeutics Inc. 72542-124 72542-124-01 1 BOTTLE in 1 CARTON (72542-124-01) / 90 CAPSULE in 1 BOTTLE
MIPLYFFA arimoclomol citrate CAPSULE;ORAL 214927 NDA Acer Therapeutics Inc. 72542-147 72542-147-01 1 BOTTLE in 1 CARTON (72542-147-01) / 90 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 47MG BASE
Approval Date:Sep 20, 2024TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 20, 2029
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 62MG BASE
Approval Date:Sep 20, 2024TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 20, 2029
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 93MG BASE
Approval Date:Sep 20, 2024TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 20, 2029
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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