SUTENT (nda021938)- (EQ 12.5MG BASE,EQ 25MG BASE,EQ 50MG BASE,EQ 37.5MG BASE)

Generic Name	SUNITINIB MALATE	Innovator	CPPI CV
Dosage	EQ 12.5MG BASE,EQ 25MG BASE,EQ 50MG BASE,EQ 37.5MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2021-Aug-15	NCE Excl Expiry	2011-Jan-26
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	SUTENT is a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. • treatment of adult patients with advanced renal cell carcinoma (RCC). • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. • treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
7	0	6

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 12.5MG BASE	**	**	Up	-	-
EQ 25MG BASE	**	**	Up	-	-
EQ 50MG BASE	**	**	-	-	-
EQ 37.5MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	4

Manufacturing Details of SUTENT