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Serving leading biopharmaceutical companies globally:

Fuji
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Healthtrust
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Cerilliant
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Generated: December 13, 2017

DrugPatentWatch Database Preview

CRESTOR Drug Profile

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Which patents cover Crestor, and what generic alternatives are available?

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

This drug has two hundred and twenty patent family members in fifty-two countries and twelve supplementary protection certificates in seven countries.

The generic ingredient in CRESTOR is rosuvastatin calcium. There are thirty-nine drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
IprCRESTORrosuvastatin calciumTABLET;ORAL021366-005Aug 12, 2003ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
IprCRESTORrosuvastatin calciumTABLET;ORAL021366-002Aug 12, 2003ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
IprCRESTORrosuvastatin calciumTABLET;ORAL021366-004Aug 12, 2003ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
IprCRESTORrosuvastatin calciumTABLET;ORAL021366-005Aug 12, 2003ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
IprCRESTORrosuvastatin calciumTABLET;ORAL021366-002Aug 12, 2003ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
IprCRESTORrosuvastatin calciumTABLET;ORAL021366-002Aug 12, 2003ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
IprCRESTORrosuvastatin calciumTABLET;ORAL021366-003Aug 12, 2003ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
IprCRESTORrosuvastatin calciumTABLET;ORAL021366-004Aug 12, 2003ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
IprCRESTORrosuvastatin calciumTABLET;ORAL021366-003Aug 12, 2003ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
IprCRESTORrosuvastatin calciumTABLET;ORAL021366-004Aug 12, 2003ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: CRESTOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
IprCRESTORrosuvastatin calciumTABLET;ORAL021366-004Aug 12, 2003► Subscribe► Subscribe
IprCRESTORrosuvastatin calciumTABLET;ORAL021366-002Aug 12, 2003► Subscribe► Subscribe
IprCRESTORrosuvastatin calciumTABLET;ORAL021366-005Aug 12, 2003► Subscribe► Subscribe
IprCRESTORrosuvastatin calciumTABLET;ORAL021366-003Aug 12, 2003► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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► Subscribe
5,260,440 Pyrimidine derivatives► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: CRESTOR

Country Document Number Estimated Expiration
Australia781269► Subscribe
MontenegroP33808► Subscribe
New Zealand525754► Subscribe
Germany10038108► Subscribe
Japan2001206877► Subscribe
Turkey200201888► Subscribe
China1149997► Subscribe
Japan5062940► Subscribe
Costa Rica6687► Subscribe
Costa Rica10114► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CRESTOR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2003 00024Denmark► Subscribe
042Luxembourg► Subscribe91042, EXPIRES: 20170630
90023-0Sweden► SubscribePRODUCT NAME: ROSUVASTATIN
C/GB03/033United Kingdom► SubscribePRODUCT 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
2014 00048Denmark► SubscribePRODUCT 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► SubscribePRODUCT 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
C0043France► SubscribePRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
0125Netherlands► Subscribe
0521471/01Switzerland► SubscribeFORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
544Luxembourg► SubscribePRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724
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Serving leading biopharmaceutical companies globally:

UBS
Novartis
Moodys
McKesson
McKinsey
US Army
Cantor Fitzgerald
Accenture
Harvard Business School
US Department of Justice

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 verifification 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.

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