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Last Updated: May 19, 2022

LESCOL XL Drug Patent 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.

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

DrugPatentWatch® 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

See drug prices for LESCOL XL

Recent Clinical Trials for LESCOL XL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AmgenPhase 4
Brigham and Women's HospitalPhase 4
University of California, San FranciscoPhase 4

See all LESCOL XL clinical trials

Pharmacology for LESCOL XL
Paragraph IV (Patent) Challenges for LESCOL XL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LESCOL XL Extended-release Tablets fluvastatin sodium 80 mg 021192 1 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000 See Plans and Pricing See Plans and Pricing
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000 See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing 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 See Plans and Pricing 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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