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. There are four patents protecting this drug. Additional details are available on the MIPLYFFA profile page.
The generic ingredient in MIPLYFFA is arimoclomol citrate. There is one drug master file entry for this compound. 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. There is one drug master file entry for this compound. 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: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214927
Generic Entry Date for 214927*:
Constraining patent/regulatory exclusivity:
TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER 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.
Pharmacology for NDA: 214927
| Mechanism of Action | Organic Cation Transporter 2 Inhibitors |
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 | ||||||||
| Regulatory Exclusivity Expiration: | Sep 20, 2031 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 19, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) | ||||||||
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