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Last Updated: August 19, 2022

CRESTOR Drug Patent Profile


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Which patents cover Crestor, and when can generic versions of Crestor launch?

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

This drug has forty-three patent family members in thirty-four countries.

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

DrugPatentWatch® 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
Washington University School of MedicinePhase 2
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 4
Food and Drug Administration (FDA)Phase 1

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Pharmacology for CRESTOR
Paragraph IV (Patent) Challenges for CRESTOR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CRESTOR Tablets rosuvastatin calcium 5 mg, 10 mg, 20 mg and 40 mg 021366 9 2007-08-13

US Patents and Regulatory Information for CRESTOR

CRESTOR is protected by one US patents and one FDA Regulatory Exclusivity.

Patents protecting CRESTOR

Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting CRESTOR

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)
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021366-004 Aug 12, 2003 See Plans and Pricing See Plans and Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003 See Plans and Pricing See Plans and Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003 See Plans and Pricing See Plans and Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003 See Plans and Pricing See Plans and Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CRESTOR

See the table below for patents covering CRESTOR around the world.

Country Patent Number Title Estimated Expiration
South Korea 100698333 See Plans and Pricing
South Korea 20010101390 See Plans and Pricing
Canada 2072945 DERIVES PYRIMIDIQUES (PYRIMIDINE DERIVATIVES) See Plans and Pricing
Japan 2008120800 MEANS FOR ASCERTAINING INDIVIDUAL'S RISK PROFILE FOR ATHEROSCLEROTIC DISEASE See Plans and Pricing
Malaysia 122707 PHARMACEUTICAL COMPOSITIONS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CRESTOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0521471 0391023-9 Sweden See Plans and Pricing PRODUCT NAME: ROSUVASTATIN
0720599 300688 Netherlands See Plans and Pricing PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NATIONAL REGISTRATION NO/DATE: RVG114002-004 20140811; FIRST REGISTRATION: NO 13-9663 - 9665 20140724
0521471 C00521471/01 Switzerland See Plans and Pricing FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
0720599 CR 2014 00048 Denmark See Plans and Pricing PRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724
0521471 0390023-0 Sweden See Plans and Pricing PRODUCT NAME: ROSUVASTATIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.