EXFORGE HCT (nda022314)- (EQ 5MG BASE;12.5MG;160MG,EQ 5MG BASE;25MG;160MG,EQ 10MG BASE;12.5MG;160MG,EQ 10MG BASE;25MG;160MG,EQ 10MG BASE;25MG;320MG)

Generic Name	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	Innovator	NOVARTIS
Dosage	EQ 5MG BASE;12.5MG;160MG,EQ 5MG BASE;25MG;160MG,EQ 10MG BASE;12.5MG;160MG,EQ 10MG BASE;25MG;160MG,EQ 10MG BASE;25MG;320MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2023-Nov-16	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Exforge HCT is a combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), valsartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a thiazide diuretic. Exforge HCT is indicated for the treatment of hypertension to lower blood pressure. 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
3	0	3

Other Developers

Total Other Developers	6

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 5MG BASE;12.5MG;160MG	**	**	-	-	2
EQ 5MG BASE;25MG;160MG	**	**	-	-	2
EQ 10MG BASE;12.5MG;160MG	**	**	-	-	2
EQ 10MG BASE;25MG;160MG	**	**	-	-	2
EQ 10MG BASE;25MG;320MG	**	**	Up	-	2

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of EXFORGE HCT