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Last Updated: October 31, 2020

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CRESTOR Drug Profile

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Which patents cover Crestor, and what generic alternatives are available?

Crestor is a drug marketed by IPR and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred patent family members in forty-nine countries.

The generic ingredient in CRESTOR is rosuvastatin calcium. There are forty-two drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.

US ANDA Litigation and Generic Entry Outlook for Crestor

A generic version of CRESTOR was approved as rosuvastatin calcium by WATSON LABS INC on April 29th, 2016.

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Drug patent expirations by year for CRESTOR
Drug Prices for CRESTOR

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Drug Sales Revenue Trends for CRESTOR

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Recent Clinical Trials for CRESTOR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Cleveland ClinicPhase 4
Brigham and Women's HospitalPhase 4
Food and Drug Administration (FDA)Phase 1

See all CRESTOR clinical trials

Pharmacology for CRESTOR
Paragraph IV (Patent) Challenges for CRESTOR
Tradename Dosage Ingredient NDA Submissiondate
CRESTOR TABLET;ORAL rosuvastatin calcium 021366 2007-08-13

US Patents and Regulatory Information for CRESTOR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CRESTOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 021366-005 Aug 12, 2003   Start Trial   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CRESTOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0521471 0391023-9 Sweden   Start Trial PRODUCT NAME: ROSUVASTATIN
0521471 0390023-0 Sweden   Start Trial PRODUCT NAME: ROSUVASTATIN
0720599 C300688 Netherlands   Start Trial PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724
0521471 91042 Luxembourg   Start Trial 91042, EXPIRES: 20170630
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Express Scripts
Merck
Mallinckrodt
Johnson and Johnson

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