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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-one drug master file entries for this compound. Thirteen suppliers are listed for this compound. There are ten tentative approvals for this compound. Additional details are available on the rosuvastatin calcium profile page.

Summary for Tradename: CRESTOR

Suppliers / Packagers: see list70
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

Rosuvastatin in the Treatment of Rectal Cancer
Status: Not yet recruiting Condition: Rectal Cancer

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003RXNoRE37314*PED<disabled> <disabled>
rosuvastatin calcium
TABLET;ORAL021366-005Aug 12, 2003RXYes7,030,152*PED<disabled>Y<disabled>
rosuvastatin calcium
TABLET;ORAL021366-003Aug 12, 2003RXNo7,964,614*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

Non-Orange Book Patents for Tradename: CRESTOR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,260,440 Pyrimidine derivatives<disabled in preview>
6,548,513 Pharmaceutical compositions<disabled in preview>
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ISSN: 2162-2639

Preferred citation:

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

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