LIPTRUZET (nda200153)- (EQ 10MG BASE;10MG,EQ 20MG BASE;10MG,EQ 40MG BASE;10MG,EQ 80MG BASE;10MG)

Generic Name	ATORVASTATIN CALCIUM; EZETIMIBE	Innovator	ORGANON
Dosage	EQ 10MG BASE;10MG,EQ 20MG BASE;10MG,EQ 40MG BASE;10MG,EQ 80MG BASE;10MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2017-Apr-25	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LIPTRUZET, 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
1	0	1

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

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

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of LIPTRUZET