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Last Updated: May 24, 2024

Details for New Drug Application (NDA): 208078

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NDA 208078 describes FIRDAPSE, which is a drug marketed by Catalyst Pharms and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the FIRDAPSE profile page.

The generic ingredient in FIRDAPSE is amifampridine phosphate. One supplier is listed for this compound. Additional details are available on the amifampridine phosphate profile page.
Summary for 208078
Applicant:Catalyst Pharms
Ingredient:amifampridine phosphate
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208078
Generic Entry Date for 208078*:
Constraining patent/regulatory exclusivity:

*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: 208078
Mechanism of ActionPotassium Channel Antagonists
Suppliers and Packaging for NDA: 208078
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FIRDAPSE amifampridine phosphate TABLET;ORAL 208078 NDA Catalyst Pharmaceuticals, Inc. 69616-211 69616-211-03 240 TABLET in 1 BOTTLE, PLASTIC (69616-211-03)
FIRDAPSE amifampridine phosphate TABLET;ORAL 208078 NDA Catalyst Pharmaceuticals, Inc. 69616-211 69616-211-06 12 BLISTER PACK in 1 CARTON (69616-211-06) / 10 TABLET in 1 BLISTER PACK (69616-211-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Nov 28, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 29, 2025
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Nov 28, 2025
Patent:⤷  Sign UpPatent Expiration:Feb 25, 2037Product Flag?YSubstance Flag?Delist Request?

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