TORISEL (nda022088)- (25MG/ML (25MG/ML))

Generic Name	TEMSIROLIMUS	Innovator	PF PRISM CV
Dosage	25MG/ML (25MG/ML)
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2032-Nov-10	NCE Excl Expiry	2012-May-30
ODE Expiry	2014-May-30	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	TORISEL® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	2

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
25MG/ML (25MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	2

Manufacturing Details of TORISEL