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Last Updated: June 25, 2021

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CRESTOR Drug 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 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-two suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.

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 2
The Cleveland ClinicPhase 4
Brigham and Women's HospitalPhase 4

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   Get Started Free   Get Started Free   Get Started Free
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 AB RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>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   Get Started Free   Get Started Free
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003   Get Started Free   Get Started Free
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003   Get Started Free   Get Started Free
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003   Get Started Free   Get Started Free
>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   Get Started Free PRODUCT NAME: ROSUVASTATIN
0521471 C300125 Netherlands   Get Started Free 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 CA 2003 00024 Denmark   Get Started Free
0521471 0390023-0 Sweden   Get Started Free PRODUCT NAME: ROSUVASTATIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
Mallinckrodt
Merck
Baxter
Dow

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