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CRESTOR Drug Profile

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Crestor is a drug marketed by IPR and is included in one NDA. It is available from fourteen suppliers. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and fifteen patent family members in fifty-two countries.

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

Summary for Tradename: CRESTOR

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list14

Pharmacology for Tradename: CRESTOR

Clinical Trials for: CRESTOR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-005Aug 12, 2003RXYes<disabled><disabled>
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003RXNoRE37314*PED<disabled> <disabled>
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-004Aug 12, 2003RXNo6,858,618*PED<disabled>Y<disabled>
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Expired Patents for Tradename: CRESTOR

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-005Aug 12, 2003RE37314*PED<disabled>
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003RE37314*PED<disabled>
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-004Aug 12, 2003RE37314*PED<disabled>
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Paragraph IV activity for: CRESTOR

Drugname Dosage Strength RLD Submissiondate
rosuvastatin calciumTablets5 mg, 10 mg, 20 mg and 40 mgCrestor8/13/2007

Non-Orange Book Patents for Tradename: CRESTOR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,548,513 Pharmaceutical compositions<disabled in preview>
5,260,440 Pyrimidine derivatives<disabled in preview>
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International Patent Family for Tradename: CRESTOR

Country Document Number Estimated Expiration
Netherlands1015859<disabled in preview>
South Korea100698333<disabled in preview>
Estonia05221<disabled in preview>
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Supplementary Protection Certificates for Tradename: CRESTOR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00048Denmark<disabled>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
00125Netherlands<disabled>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
C/GB03/033United Kingdom<disabled>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
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