ROSZET (nda213072)- (10MG;EQ 5MG BASE,10MG;EQ 10MG BASE,10MG;EQ 20MG BASE,10MG;EQ 40MG BASE)

Generic Name	EZETIMIBE; ROSUVASTATIN CALCIUM	Innovator	ALTHERA PHARMS
Dosage	10MG;EQ 5MG BASE,10MG;EQ 10MG BASE,10MG;EQ 20MG BASE,10MG;EQ 40MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2033-May-01	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ROSZET is a combination of rosuvastatin, an HMG CoA-reductase inhibitor (statin), and ezetimibe, a dietary cholesterol absorption inhibitor, indicated in adults: • As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDLC). • Alone or as an adjuct to other LDL-C lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

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
10MG;EQ 5MG BASE	**	**	-	-	-
10MG;EQ 10MG BASE	**	**	-	-	-
10MG;EQ 20MG BASE	**	**	-	-	-
10MG;EQ 40MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ROSZET