AMTURNIDE (nda200045)- (EQ 150MG BASE;EQ 5MG BASE;12.5MG,EQ 300MG BASE;EQ 5MG BASE;12.5MG,EQ 300MG BASE;EQ 5MG BASE;25MG,EQ 300MG BASE;EQ 10MG BASE;12.5MG,EQ 300MG BASE;EQ 10MG BASE;25MG)

Generic Name	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE	Innovator	NOVARTIS
Dosage	EQ 150MG BASE;EQ 5MG BASE;12.5MG,EQ 300MG BASE;EQ 5MG BASE;12.5MG,EQ 300MG BASE;EQ 5MG BASE;25MG,EQ 300MG BASE;EQ 10MG BASE;12.5MG,EQ 300MG BASE;EQ 10MG BASE;25MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2023-May-16	NCE Excl Expiry	2012-Mar-05
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Amturnide is a combination of aliskiren, a renin inhibitor, amlodipine besylate, a dihydropyridine calcium channel blocker, and hydrochlorothiazide (HCTZ), a thiazide diuretic indicated for the treatment of hypertension:

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;12.5MG	**	**	-	-	-
EQ 300MG BASE;EQ 5MG BASE;12.5MG	**	**	-	-	-
EQ 300MG BASE;EQ 5MG BASE;25MG	**	**	-	-	-
EQ 300MG BASE;EQ 10MG BASE;12.5MG	**	**	-	-	-
EQ 300MG BASE;EQ 10MG BASE;25MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of AMTURNIDE