SIGNIFOR LAR KIT (nda203255)- (EQ 20MG BASE/VIAL,EQ 40MG BASE/VIAL,EQ 60MG BASE/VIAL,EQ 10MG BASE/VIAL,EQ 30MG BASE/VIAL)

Generic Name	PASIREOTIDE PAMOATE	Innovator	RECORDATI RARE
Dosage	EQ 20MG BASE/VIAL,EQ 40MG BASE/VIAL,EQ 60MG BASE/VIAL,EQ 10MG BASE/VIAL,EQ 30MG BASE/VIAL
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2028-May-23	NCE Excl Expiry	2017-Dec-14
ODE Expiry	2021-Dec-15	NP Expiry	2017-Dec-15
GAIN Expiry	None	Drug Complexity	No
Indication	SIGNIFOR LAR is a somatostatin analog indicated for the treatment of: • Patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. • 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 20MG BASE/VIAL	**	**	-	-	-
EQ 40MG BASE/VIAL	**	**	-	-	-
EQ 60MG BASE/VIAL	**	**	-	-	-
EQ 10MG BASE/VIAL	**	**	-	-	-
EQ 30MG BASE/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of SIGNIFOR LAR KIT