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LESCOL XL Drug Profile

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Lescol Xl is a drug marketed by Novartis and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in nineteen countries.

The generic ingredient in LESCOL XL is fluvastatin sodium. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the fluvastatin sodium profile page.

Summary for Tradename: LESCOL XL

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Drug Prices: :see details

Pharmacology for Tradename: LESCOL XL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
LESCOL XL
fluvastatin sodium
TABLET, EXTENDED RELEASE;ORAL021192-001Oct 6, 2000RXYes6,242,003*PED► subscribeY► subscribe
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Expired Patents for Tradename: LESCOL XL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
LESCOL XL
fluvastatin sodium
TABLET, EXTENDED RELEASE;ORAL021192-001Oct 6, 20005,354,772*PED► subscribe
Novartis
LESCOL XL
fluvastatin sodium
TABLET, EXTENDED RELEASE;ORAL021192-001Oct 6, 20005,356,896*PED► subscribe
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Paragraph IV activity for: LESCOL XL

Drugname Dosage Strength RLD Submissiondate
fluvastatin sodiumExtended-release Tablets80 mgLescol XL3/15/2007

Non-Orange Book Patents for Tradename: LESCOL XL

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
6,432,447 Organic compounds► subscribe
8,303,987Pharmaceutical compositions comprising fluvastatin► 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: LESCOL XL

Country Document Number Estimated Expiration
Russian Federation2002129570► subscribe
South Korea20030019332► subscribe
European Patent Office2042163► 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: LESCOL XL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022Belgium► subscribePRODUCT NAME: FLUVASTATINE SODIQUE; NAT. REGISTRATION NO/DATE: 151 IS 207 F 4 19960409; FIRST REGISTRATION: GB 0101/0360 19930823
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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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