Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 5, 2019

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 seven suppliers. There are two 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 forty-two drug master file entries for this compound. Forty-five 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:2
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 0310-0751-39 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0310-0751-39)
CRESTOR rosuvastatin calcium TABLET;ORAL 021366 NDA AstraZeneca Pharmaceuticals LP 0310-0751 0310-0751-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0751-90)
Paragraph IV (Patent) Challenges for 021366
Tradename Dosage Ingredient NDA Submissiondate
CRESTOR TABLET;ORAL rosuvastatin calcium 021366 2007-08-13

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)
Patent:  Start TrialPatent Expiration:Feb 4, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jun 17, 2022Product 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 021366-003 Aug 12, 2003   Start Trial   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003   Start Trial   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003   Start Trial   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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