JUXTAPID (nda203858)- (EQ 5MG BASE,EQ 10MG BASE,EQ 20MG BASE,EQ 30MG BASE,EQ 40MG BASE,EQ 60MG BASE)

Generic Name	LOMITAPIDE MESYLATE	Innovator	CHIESI
Dosage	EQ 5MG BASE,EQ 10MG BASE,EQ 20MG BASE,EQ 30MG BASE,EQ 40MG BASE,EQ 60MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2027-Aug-19	NCE Excl Expiry	2017-Dec-21
ODE Expiry	2019-Dec-21	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	JUXTAPID is a microsomal triglyceride transfer protein inhibitor indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-highdensity lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

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 5MG BASE	**	**	-	-	-
EQ 10MG BASE	**	**	-	-	-
EQ 20MG BASE	**	**	-	-	-
EQ 30MG BASE	**	**	-	-	-
EQ 40MG BASE	**	**	-	-	-
EQ 60MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of JUXTAPID