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Last Updated: October 12, 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-nine 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
The Searle Company LimitedN/A
University of KarachiN/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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 ⤷  Sign Up ⤷  Sign Up
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003 ⤷  Sign Up ⤷  Sign Up
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003 ⤷  Sign Up ⤷  Sign Up
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003 ⤷  Sign Up ⤷  Sign Up
>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
Australia 781269 ⤷  Sign Up
Hong Kong 1056691 ⤷  Sign Up
Estonia 04990 HMG reduktaasi inhibiitorit sisaldavad farmatseutilised kompositsioonid, nende kasutamine ja saamismeetod ⤷  Sign Up
New Zealand 525754 Use of rosuvastatin (ZD-4522) in the treatment of heterozygous familial hypercholesterolemia ⤷  Sign Up
Canada 2639407 COMPOSITIONS PHARMACEUTIQUES COMPORTANT DE L'ACIDE (E)-7-[4-(4-FLUOROPHENYL)-6-ISOPROPYL-2-[METHYL(METHYLSULFONYL)AMINO]- PYRIMIDIN-5-YL]-(3R, 5S)-DIHYDROXYHEPT-6-ENOIQUE OU UN SEL ACCEPTABLE DE CELUI-CI (PHARMACEUTICAL COMPOSITIONS COMPRISING (E)-7-[4-(4-FLUOROPHENYL)-6-ISOPROPYL-2-[METHYL(METHYLSULFONYL)AMINO]PYRIMIDIN-5-YL]-(3R,5S)-3,5-DIHYDROXYHEPT-6-ENOIC ACID OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CRESTOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 92544 Luxembourg ⤷  Sign Up PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724
0720599 CR 2014 00048 Denmark ⤷  Sign Up 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 SPC/GB03/033 United Kingdom ⤷  Sign Up PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321
0521471 0391023-9 Sweden ⤷  Sign Up PRODUCT NAME: ROSUVASTATIN
0521471 0390023-0 Sweden ⤷  Sign Up PRODUCT NAME: ROSUVASTATIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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