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Last Updated: March 19, 2024

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.

The generic ingredient in CRESTOR is rosuvastatin calcium. There are forty-two drug master file entries for this compound. Forty-four 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
Wake Forest University Health SciencesPhase 4
University of KarachiN/A
The Searle Company LimitedN/A

See all CRESTOR clinical trials

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

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 021366-003 Aug 12, 2003 ⤷  Try a Trial ⤷  Try a Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 ⤷  Try a Trial ⤷  Try a Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003 ⤷  Try a Trial ⤷  Try a Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 ⤷  Try a Trial ⤷  Try a Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 ⤷  Try a Trial ⤷  Try a Trial
>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
Estonia 04990 HMG reduktaasi inhibiitorit sisaldavad farmatseutilised kompositsioonid, nende kasutamine ja saamismeetod ⤷  Try a Trial
United Kingdom 2358583 Pharmaceutical compositions ⤷  Try a Trial
Israel 150513 ⤷  Try a Trial
Hong Kong 1040936 ⤷  Try a Trial
Iceland 2410 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CRESTOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0521471 03C0043 France ⤷  Try a Trial PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
0521471 C300125 Netherlands ⤷  Try a Trial PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
0521471 C00521471/01 Switzerland ⤷  Try a Trial FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
0521471 0391023-9 Sweden ⤷  Try a Trial PRODUCT NAME: ROSUVASTATIN
0720599 CR 2014 00048 Denmark ⤷  Try a Trial 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
>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.