CADUET (nda021540)- (EQ 5MG BASE;EQ 10MG BASE,EQ 5MG BASE;EQ 20MG BASE,EQ 5MG BASE;EQ 40MG BASE,EQ 5MG BASE;EQ 80MG BASE,EQ 10MG BASE;EQ 10MG BASE,EQ 10MG BASE;EQ 20MG BASE,EQ 10MG BASE;EQ 40MG BASE,EQ 10MG BASE;EQ 80MG BASE,EQ 2.5MG BASE;EQ 10MG BASE,EQ 2.5MG BASE;EQ 20MG BASE,EQ 2.5MG BASE;EQ 40MG BASE)

Generic Name	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	Innovator	PHARMACIA
Dosage	EQ 5MG BASE;EQ 10MG BASE,EQ 5MG BASE;EQ 20MG BASE,EQ 5MG BASE;EQ 40MG BASE,EQ 5MG BASE;EQ 80MG BASE,EQ 10MG BASE;EQ 10MG BASE,EQ 10MG BASE;EQ 20MG BASE,EQ 10MG BASE;EQ 40MG BASE,EQ 10MG BASE;EQ 80MG BASE,EQ 2.5MG BASE;EQ 10MG BASE,EQ 2.5MG BASE;EQ 20MG BASE,EQ 2.5MG BASE;EQ 40MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2018-Aug-11	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CADUET is a combination of amlodipine besylate, a calcium channel blocker, and atorvastatin calcium, a HMG CoA-reductase inhibitor, indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine 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. Amlodipine is indicated for the treatment of Coronary Artery Disease. Atorvastatin is indicated as an adjunct therapy to diet for prevention of cardiovascular disease and hyperlipidemia.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	0	4

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 5MG BASE;EQ 10MG BASE	**	**	Up	-	2
EQ 5MG BASE;EQ 20MG BASE	**	**	Down	-	2
EQ 5MG BASE;EQ 40MG BASE	**	**	Up	-	2
EQ 5MG BASE;EQ 80MG BASE	**	**	-	-	2
EQ 10MG BASE;EQ 10MG BASE	**	**	Up	-	2
EQ 10MG BASE;EQ 20MG BASE	**	**	Up	-	2
EQ 10MG BASE;EQ 40MG BASE	**	**	Up	-	2
EQ 10MG BASE;EQ 80MG BASE	**	**	Down	-	2
EQ 2.5MG BASE;EQ 10MG BASE	**	**	-	-	-
EQ 2.5MG BASE;EQ 20MG BASE	**	**	-	-	-
EQ 2.5MG BASE;EQ 40MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of CADUET