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.
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: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 47MG BASE | ||||
| Approval Date: | Sep 20, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 20, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 62MG BASE | ||||
| Approval Date: | Sep 20, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 20, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 93MG BASE | ||||
| Approval Date: | Sep 20, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 20, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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