ALTOPREV (nda021316)- (10MG,20MG,40MG,60MG)

Generic Name	LOVASTATIN	Innovator	COVIS
Dosage	10MG,20MG,40MG,60MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2018-Mar-23	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ALTOPREV is indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower Total-C and LDL-C to target levels. ALTOPREV is indicated as an adjunct to diet for the reduction of elevated Total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson types IIa and IIb) when the response to diet restricted in saturated fat and cholesterol and to other non-pharmacological measures alone has been inadequate.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	3

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
10MG	**	**	-	-	-
20MG	**	**	-	-	-
40MG	**	**	-	-	-
60MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ALTOPREV