Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

How our clients use DrugPatentWatch

DrugPatentWatch Database Preview

CRESTOR Drug Profile

« Back to Dashboard

Which patents cover Crestor, and what substitute generic drugs 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 fifteen patent family members in fifty-two countries.

The generic ingredient in CRESTOR is rosuvastatin calcium. There are thirty-seven drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. There are three 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
Bulk Api Vendors: see list63
Clinical Trials: see list119
Patent Applications: see list6,548
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:CRESTOR at DailyMed

Pharmacology for Tradename: CRESTOR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-005Aug 12, 2003RXYesYes► Subscribe► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003RXYesNo6,316,460*PED► SubscribeY► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-004Aug 12, 2003RXYesNo7,964,614*PED► SubscribeY► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-005Aug 12, 2003RXYesYes6,858,618*PED► SubscribeY► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003RXYesNo► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Tradename: CRESTOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-003Aug 12, 2003RE37314*PED► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003RE37314*PED► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-004Aug 12, 2003RE37314*PED► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-005Aug 12, 2003RE37314*PED► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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► Subscribe
5,260,440 Pyrimidine derivatives► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: CRESTOR

Country Document Number Estimated Expiration
Australia6580000► Subscribe
Canada2639407► Subscribe
Denmark178242► Subscribe
Slovenia1339409► Subscribe
Czech Republic301583► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: CRESTOR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0125Netherlands► Subscribe
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
91023-9Sweden► SubscribePRODUCT NAME: ROSUVASTATIN
00688Netherlands► SubscribePRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724
0521471/01Switzerland► SubscribeFORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How our clients use DrugPatentWatch

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.

`abc