EXFORGE (nda021990)- (EQ 5MG BASE;160MG,EQ 10MG BASE;160MG,EQ 5MG BASE;320MG,EQ 10MG BASE;320MG)

Generic Name	AMLODIPINE BESYLATE; VALSARTAN	Innovator	NOVARTIS
Dosage	EQ 5MG BASE;160MG,EQ 10MG BASE;160MG,EQ 5MG BASE;320MG,EQ 10MG BASE;320MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2019-Jul-08	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Exforge is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Exforge is indicated for the treatment of hypertension, to lower blood pressure: • In patients not adequately controlled on 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
8	0	6

Other Developers

Total Other Developers	11

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 5MG BASE;160MG	**	**	-	-	4
EQ 10MG BASE;160MG	**	**	-	-	4
EQ 5MG BASE;320MG	**	**	-	4	-
EQ 10MG BASE;320MG	**	**	-	-	4

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	6

Manufacturing Details of EXFORGE