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Farmers Insurance
Dow
Baxter
McKesson
Novartis
Merck
Cipla
Queensland Health
Healthtrust
QuintilesIMS

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021366

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NDA 021366 describes CRESTOR, which is a drug marketed by IPR and is included in one NDA. It is available from thirteen suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CRESTOR profile page.

The generic ingredient in CRESTOR is rosuvastatin calcium. There are thirty-nine drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.
Summary for 021366
Tradename:CRESTOR
Applicant:Ipr
Ingredient:rosuvastatin calcium
Patents:4
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021366
Medical Subject Heading (MeSH) Categories for 021366
Suppliers and Packaging for NDA: 021366
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CRESTOR rosuvastatin calcium TABLET;ORAL 021366 NDA AstraZeneca Pharmaceuticals LP 0310-0751 N 0310-0751-90
CRESTOR rosuvastatin calcium TABLET;ORAL 021366 NDA AstraZeneca Pharmaceuticals LP 0310-0751 N 0310-0751-39

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 12, 2003TE:ABRLD:Yes
Regulatory Exclusivity Expiration:May 27, 2023
Regulatory Exclusivity Use:AN ADJUNCT TO DIET TO REDUCE LDL-C, TOTAL-C, NONHDL-C AND APOB IN CHILDREN AND ADOLESCENTS 7 TO 17 YEARS OF AGE WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA, EITHER ALONE OR WITH OTHER LIPID-LOWERING TREATMENTS (E.G., LDL APHERESIS)
Regulatory Exclusivity Expiration:Nov 20, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Try a Free TrialPatent Expiration:Feb 4, 2021Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021366

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Harvard Business School
Federal Trade Commission
Citi
US Department of Justice
Chubb
UBS
Johnson and Johnson
Cantor Fitzgerald
Argus Health

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