DIOVAN HCT (nda020818)- (12.5MG;80MG,12.5MG;160MG,12.5MG;320MG,25MG;160MG,25MG;320MG)

Generic Name	HYDROCHLOROTHIAZIDE; VALSARTAN	Innovator	NOVARTIS
Dosage	12.5MG;80MG,12.5MG;160MG,12.5MG;320MG,25MG;160MG,25MG;320MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2017-Dec-18	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Diovan HCT is the combination tablet of valsartan (Diovan), an angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ), a diuretic. Diovan HCT is 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 Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
7	2	7

Other Developers

Total Other Developers	13

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
12.5MG;80MG	**	**	-	-	5
12.5MG;160MG	**	**	-	-	5
12.5MG;320MG	**	**	-	-	5
25MG;160MG	**	**	-	-	5
25MG;320MG	**	**	-	-	5

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	6

Manufacturing Details of DIOVAN HCT