FABHALTA (NDA218276)- (EQ 200MG BASE)

Generic Name	IPTACOPAN HYDROCHLORIDE	Innovator	NOVARTIS
Dosage	EQ 200MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2041-Jul-15	NCE Excl Expiry	2028-Dec-05
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	FABHALTA is a complement factor B inhibitor, indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 200MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of FABHALTA