OGSIVEO (NDA217677)- (EQ 50MG BASE,EQ 100MG BASE,EQ 150MG BASE)

Generic Name	NIROGACESTAT HYDROBROMIDE	Innovator	SPRINGWORKS
Dosage	EQ 50MG BASE,EQ 100MG BASE,EQ 150MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2043-May-19	NCE Excl Expiry	2028-Nov-27
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	OGSIVEO is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment.

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 50MG BASE	**	**	-	-	-
EQ 100MG BASE	**	**	-	-	-
EQ 150MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of OGSIVEO