LIPITOR (nda020702)- (EQ 10MG BASE,EQ 20MG BASE,EQ 40MG BASE,EQ 80MG BASE)

Generic Name	ATORVASTATIN CALCIUM	Innovator	UPJOHN
Dosage	EQ 10MG BASE,EQ 20MG BASE,EQ 40MG BASE,EQ 80MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2017-Jan-08	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LIPITOR is an HMG-CoA reductase inhibitor indicated as an adjunct therapy to diet to: • Reduce the risk of MI, stroke, revascularization procedures, and angina in adult patients without CHD, but with multiple risk factors • Reduce the risk of MI and stroke in adult patients with type 2 diabetes without CHD, but with multiple risk factors • Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in adult patients with CHD • Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia • Reduce elevated TG in adult patients with hypertriglyceridemia and primary dysbetalipoproteinemia • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) • Reduce elevated total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trial of diet therapy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
30	0	26

Other Developers

Total Other Developers	35

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 10MG BASE	**	**	Up	-	18
EQ 20MG BASE	**	**	Up	-	19
EQ 40MG BASE	**	**	Up	-	19
EQ 80MG BASE	**	**	-	-	18

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	17

Manufacturing Details of LIPITOR