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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
Tradename:FIRDAPSE
Applicant:Catalyst Pharms
Ingredient:amifampridine phosphate
Patents:6
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208078
Generic Entry Date for 208078*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 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
Regulatory Exclusivity Use:TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME (LEMS)
Patent:⤷  Sign UpPatent Expiration:Feb 25, 2037Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.