TEKTURNA HCT (nda022107)- (EQ 150MG BASE;12.5MG,EQ 150MG BASE;25MG,EQ 300MG BASE;12.5MG,EQ 300MG BASE;25MG)

Generic Name	ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE	Innovator	NODEN PHARMA
Dosage	EQ 150MG BASE;12.5MG,EQ 150MG BASE;25MG,EQ 300MG BASE;12.5MG,EQ 300MG BASE;25MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2028-Jul-13	NCE Excl Expiry	2012-Mar-05
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Tekturna HCT is a combination of aliskiren, a renin inhibitor, and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure: • In patients not adequately controlled with monotherapy. • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	1	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;12.5MG	**	**	-	-	-
EQ 150MG BASE;25MG	**	**	-	-	-
EQ 300MG BASE;12.5MG	**	**	-	-	-
EQ 300MG BASE;25MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TEKTURNA HCT