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Profile for Tradename: CRESTOR

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Crestor is a drug marketed by IPR and is included in one NDA. It is available from thirteen suppliers. There are five patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in CRESTOR is rosuvastatin calcium. There are thirty drug master file entries for this compound. Thirteen suppliers are listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the rosuvastatin calcium profile page.

Summary for Tradename: CRESTOR

Suppliers: see list13
2013 Sales:$5,310,818,000

Pharmacology for Tradename: CRESTOR

Clinical Trials for: CRESTOR

CKD-346 DDI Study(Telmisartan/S-Amlodipine, Rosuvastatin)
Status: Completed Condition: Hypertension; Hyperlipidemia

The Effects of Rifampin on the Pharmacokinetics of Rosuvastatin
Status: Recruiting Condition: Healthy

A Study to Assess the Effects of Multiple Doses of Fidaxomicin on a Single Dose of Rosuvastatin in Healthy Male Subjects
Status: Completed Condition: Drug-Drug Interaction (DDI); Intestinal Absorption; Healthy Subjects; Pharmacokinetics of Rosuvastatin; Pharmacokinetics of Fidaxomicin

The Rosuvastatin In TrAnsplant Recipients Study
Status: Completed Condition: Disorder Related to Renal Transplantation; Hypercholesterolemia

The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine
Status: Completed Condition: Hypertension; Hyperlipidemia

A Phase 1 Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Crestor and Glucodown OR SR in Healthy Volunteers
Status: Completed Condition: Pharmacokinetics and Drug Interaction of Crestor and Glucodown SR

Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 20mg
Status: Completed Condition: Diabetes Mellitus

Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome
Status: Completed Condition: Metabolic Syndrome

Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 500mg and Rosuvastatin 10mg
Status: Completed Condition: Diabetes Mellitus

A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.
Status: Recruiting Condition: Hypercholesterolemia

Courtesy of
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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
rosuvastatin calcium
TABLET;ORAL021366-005Aug 12, 2003RXYesRE37314*PED<disabled><disabled>
rosuvastatin calcium
TABLET;ORAL021366-004Aug 12, 2003RXNo7,964,614*PED<disabled>Y<disabled>
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003RXNoRE37314*PED<disabled><disabled>
rosuvastatin calcium
TABLET;ORAL021366-003Aug 12, 2003RXNo6,316,460*PED<disabled>Y<disabled>
rosuvastatin calcium
TABLET;ORAL021366-004Aug 12, 2003RXNo7,030,152*PED<disabled>Y<disabled>
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Paragraph IV activity for: CRESTOR

Drugname Dosage Strength RLD Submissiondate
rosuvastatin calciumTablets5 mg, 10 mg, 20 mg and 40 mgCrestor8/13/2007
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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