SANDOSTATIN (nda019667)- (EQ 0.05MG BASE/ML,EQ 0.1MG BASE/ML,EQ 0.5MG BASE/ML,EQ 0.2MG BASE/ML,EQ 1MG BASE/ML)

Generic Name	OCTREOTIDE ACETATE	Innovator	NOVARTIS
Dosage	EQ 0.05MG BASE/ML,EQ 0.1MG BASE/ML,EQ 0.5MG BASE/ML,EQ 0.2MG BASE/ML,EQ 1MG BASE/ML
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2015-Nov-19	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Sandostatin® (octreotide acetate) Injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. Sandostatin is indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. Sandostatin is indicated for the treatment of the profuse watery diarrhea associated with VIP-secreting tumors.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
14	0	12

Other Developers

Total Other Developers	20

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 0.05MG BASE/ML	**	**	-	-	3
EQ 0.1MG BASE/ML	**	**	-	-	5
EQ 0.5MG BASE/ML	**	**	-	-	-
EQ 0.2MG BASE/ML	**	**	-	-	-
EQ 1MG BASE/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	10

Manufacturing Details of SANDOSTATIN