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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

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

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

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

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 500mg and Rosuvastatin 10mg
Status: Completed Condition: Diabetes Mellitus

Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks
Status: Completed Condition: Hypercholesterolemia; Coronary Heart Disease

Evaluating of Pharmacokinetic Profile of BCWP_C001 and Co-administration of Rosuvastatin and Metformin
Status: Not yet recruiting Condition: Healthy

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;ORAL021366Aug 12, 2003RXYesRE37314*PED<disabled><disabled>
rosuvastatin calcium
TABLET;ORAL021366Aug 12, 2003RXNo6,316,460*PED<disabled>Y<disabled>
rosuvastatin calcium
TABLET;ORAL021366Aug 12, 2003RXNoRE37314*PED<disabled><disabled>
rosuvastatin calcium
TABLET;ORAL021366Aug 12, 2003RXNo7,964,614*PED<disabled>Y<disabled>
rosuvastatin calcium
TABLET;ORAL021366Aug 12, 2003RXYes6,858,618*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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