SOMATULINE DEPOT (nda022074)- (EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML),EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML),EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML))

Generic Name	LANREOTIDE ACETATE	Innovator	IPSEN PHARMA
Dosage	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML),EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML),EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2020-Mar-08	NCE Excl Expiry	2012-Aug-30
ODE Expiry	2014-Aug-30	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	SOMATULINE DEPOT is a somatostatin analog indicated for: • the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. • the treatment of adult patients with unresectable, well-or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. • the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

Other Developers

Total Other Developers	15

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	**	**	-	-	-
EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	**	**	-	-	-
EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of SOMATULINE DEPOT