TEKAMLO (nda022545)- (EQ 150MG BASE;EQ 5MG BASE,EQ 150MG BASE;EQ 10MG BASE,EQ 300MG BASE;EQ 5MG BASE,EQ 300MG BASE;EQ 10MG BASE)

Generic Name	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE	Innovator	NOVARTIS
Dosage	EQ 150MG BASE;EQ 5MG BASE,EQ 150MG BASE;EQ 10MG BASE,EQ 300MG BASE;EQ 5MG BASE,EQ 300MG BASE;EQ 10MG BASE
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2029-Dec-21	NCE Excl Expiry	2012-Mar-05
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Tekamlo is a combination of aliskiren, a renin inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, indicated for the treatment of hypertension, to lower blood pressure:  As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.  In patients not adequately controlled with monotherapy.  As a substitute for its titrated components.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

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
EQ 150MG BASE;EQ 5MG BASE	**	**	-	-	-
EQ 150MG BASE;EQ 10MG BASE	**	**	-	-	-
EQ 300MG BASE;EQ 5MG BASE	**	**	-	-	-
EQ 300MG BASE;EQ 10MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of TEKAMLO