SIGNIFOR (nda200677)- (EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML),EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML),EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML))

Generic Name	PASIREOTIDE DIASPARTATE	Innovator	RECORDATI RARE
Dosage	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML),EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML),EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2026-Dec-14	NCE Excl Expiry	2017-Dec-14
ODE Expiry	2019-Dec-14	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	SIGNIFOR is a somatostatin analog indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

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 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	**	**	-	-	-
EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	**	**	-	-	-
EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of SIGNIFOR