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Last Updated: July 13, 2020

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LESCOL XL Drug Profile


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When do Lescol Xl patents expire, and when can generic versions of Lescol Xl launch?

Lescol Xl is a drug marketed by Novartis and is included in one NDA. 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. Four suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Lescol Xl

A generic version of LESCOL XL was approved as fluvastatin sodium by MYLAN PHARMS INC on April 11th, 2012.

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Drug patent expirations by year for LESCOL XL
Drug Prices for LESCOL XL

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Recent Clinical Trials for LESCOL XL

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SponsorPhase
University of California, San FranciscoPhase 4
University of ZurichPhase 4
University of BaselPhase 4

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Pharmacology for LESCOL XL
Paragraph IV (Patent) Challenges for LESCOL XL
Tradename Dosage Ingredient NDA Submissiondate
LESCOL XL TABLET, EXTENDED RELEASE;ORAL fluvastatin sodium 021192 2007-03-15

US Patents and Regulatory Information for LESCOL XL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LESCOL XL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000   Start Trial   Start Trial
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LESCOL XL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0114027 96C0022 Belgium   Start Trial PRODUCT NAME: FLUVASTATINE SODIQUE; NAT. REGISTRATION NO/DATE: 151 IS 207 F 4 19960409; FIRST REGISTRATION: GB 0101/0360 19930823
0114027 SPC/GB93/173 United Kingdom   Start Trial SPC/GB93/173: 20031122, EXPIRES: 20080822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Colorcon
Dow
Moodys
Mallinckrodt

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