TASIGNA (nda022068)- (EQ 200MG BASE,EQ 150MG BASE,EQ 50MG BASE)

Generic Name	NILOTINIB HYDROCHLORIDE	Innovator	NOVARTIS
Dosage	EQ 200MG BASE,EQ 150MG BASE,EQ 50MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2032-Oct-07	NCE Excl Expiry	2012-Oct-29
ODE Expiry	2014-Oct-29	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Tasigna is a kinase inhibitor indicated for the treatment of:  Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.  Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.  Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	1	0

Other Developers

Total Other Developers	22

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 200MG BASE	**	**	-	-	-
EQ 150MG BASE	**	**	-	-	-
EQ 50MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TASIGNA