LIVALO (nda022363)- (EQ 1MG BASE,EQ 2MG BASE,EQ 4MG BASE)

Generic Name	PITAVASTATIN CALCIUM	Innovator	KOWA CO
Dosage	EQ 1MG BASE,EQ 2MG BASE,EQ 4MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2024-Aug-19	NCE Excl Expiry	2014-Aug-03
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LIVALO is a HMG-CoA reductase inhibitor indicated as an adjunctive therapy to diet in: • Adult patients with primary hyperlipidemia or mixed dyslipidemia to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C). • Pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B.

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
EQ 1MG BASE	**	**	Up	-	5
EQ 2MG BASE	**	**	Up	-	5
EQ 4MG BASE	**	**	Down	-	5

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	5

Manufacturing Details of LIVALO