VYTORIN (nda021687)- (10MG;10MG,10MG;20MG,10MG;40MG,10MG;80MG)

Generic Name	EZETIMIBE; SIMVASTATIN	Innovator	ORGANON
Dosage	10MG;10MG,10MG;20MG,10MG;40MG,10MG;80MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2024-Jun-11	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	VYTORIN, which contains a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet to: • reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. • reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
7	0	6

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
10MG;10MG	**	**	-	-	5
10MG;20MG	**	**	-	-	5
10MG;40MG	**	**	Up	5	-
10MG;80MG	**	**	-	-	5

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	5

Manufacturing Details of VYTORIN