FIRDAPSE (nda208078)- (EQ 10MG BASE)

Generic Name	AMIFAMPRIDINE PHOSPHATE	Innovator	CATALYST PHARMS
Dosage	EQ 10MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2037-Feb-25	NCE Excl Expiry	2023-Nov-28
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	FIRDAPSE is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 10MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of FIRDAPSE