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Details for Patent: RE37314

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Patent RE37314 protects CRESTOR and is included in one NDA. There has been one Paragraph IV challenge on Crestor. There are ten tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

Protection for CRESTOR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-two patent family members in seventeen countries.

Summary for Patent: RE37314

Title: Pyrimidine derivatives
Abstract:The compounds of the present invention inhibit the HMG-CoA reductase, and subsequently suppress the biosynthesis of cholesterol. And they are useful in the treatment of hypercholesterolemia, hyperlipoproteinemia, and atherosclerosis.
Inventor(s): Hirai; Kentaro (Kyoto, JP), Ishiba; Teruyuki (Osaka, JP), Koike; Haruo (Kyoto, JP), Watanabe; Masamichi (Shiga, JP)
Assignee: Shionogi Seiyaku Kabushiki Kaisha (Osaka, JP)
Application Number:09/141,731
Patent Claim Types:
see list of patent claims
Compound; Composition;
Patent PDF download available with subscription

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003RXNoRE37314*PED<disabled>
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-003Aug 12, 2003RXNoRE37314*PED<disabled>
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-004Aug 12, 2003RXNoRE37314*PED<disabled>
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-005Aug 12, 2003RXYesRE37314*PED<disabled>
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Foreign Priority and PCT Information for Patent: RE37314

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan3-188015Jul 01, 1991

Non-Orange Book Patents for Patent: RE37314

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
5,260,440 Pyrimidine derivatives<disabled in preview>
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International Patent Family for Patent: RE37314

Country Document Number Publication Date Supplementary Protection Certificate SPC Country SPC Expiration
Portugal521471Apr 30, 2001
Hungary0004863Feb 28, 2001
Germany122009000017Oct 21, 2010
JapanH05178841Jul 20, 1993
Germany122009000017Nov 05, 2009
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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