CRESTOR (nda021366)- (EQ 5MG BASE,EQ 10MG BASE,EQ 20MG BASE,EQ 40MG BASE)

Generic Name	ROSUVASTATIN CALCIUM	Innovator	IPR
Dosage	EQ 5MG BASE,EQ 10MG BASE,EQ 20MG BASE,EQ 40MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2022-Jun-17	NCE Excl Expiry	Expired
ODE Expiry	2023-May-27	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CRESTOR is an HMG Co-A reductase inhibitor indicated for: • adult patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDL-C • pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total-C, LDL-C and ApoB after failing an adequate trial of diet therapy • pediatric patients 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, nonHDL-C and ApoB as an adjunct to diet, either alone or with other lipid-lowering treatments • adult patients with hypertriglyceridemia as an adjunct to diet • adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet • adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB • slowing the progression of atherosclerosis as part of a treatment strategy to lower total-C and LDL-C as an adjunct to diet • risk reduction of MI, stroke, and arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
20	0	18

Other Developers

Total Other Developers	16

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 5MG BASE	**	**	Down	-	14
EQ 10MG BASE	**	**	Down	-	14
EQ 20MG BASE	**	**	Up	-	12
EQ 40MG BASE	**	**	Up	-	13

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	14

Manufacturing Details of CRESTOR