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Details for Patent: 6,316,460

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Patent 6,316,460 protects CRESTOR and is included in one NDA. There has been one Paragraph IV challenge on Crestor. There are three 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 one hundred and fifty-three patent family members in forty-seven countries.

Summary for Patent: 6,316,460

Title: Pharmaceutical compositions
Abstract:The invention concerns a pharmaceutical composition comprising the HMG CoA reductase inhibitor (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrim idin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid or a pharmaceutically acceptable salt thereof as the active ingredient, which remains stable over a prolonged period.
Inventor(s): Creekmore; Joseph R (Wilmington, DE), Wiggins; Norman A. (Wilmington, DE)
Assignee: Astrazeneca AB (Sodertalje, SE)
Application Number:09/633,064
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 18th percentile
Forward Citations: 1st percentile

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, 2003RXNo6,316,460*PED► subscribeY
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-003Aug 12, 2003RXNo6,316,460*PED► subscribeY
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-004Aug 12, 2003RXNo6,316,460*PED► subscribeY
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Foreign Priority and PCT Information for Patent: 6,316,460

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom0001621Jan 26, 2000

Non-Orange Book Patents for Patent: 6,316,460

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
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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 Patent: 6,316,460

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO)1449► subscribe
African Regional IP Organization (ARIPO)1879► subscribe
African Regional IP Organization (ARIPO)200202409► 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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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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