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Last Updated: November 21, 2024

LESCOL Drug Patent Profile


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

Lescol is a drug marketed by Novartis and Sandoz and is included in two NDAs.

The generic ingredient in LESCOL 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

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

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Summary for LESCOL
US Patents:0
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 68
Clinical Trials: 11
Patent Applications: 4,864
Drug Prices: Drug price information for LESCOL
What excipients (inactive ingredients) are in LESCOL?LESCOL excipients list
DailyMed Link:LESCOL at DailyMed
Drug patent expirations by year for LESCOL
Drug Prices for LESCOL

See drug prices for LESCOL

Recent Clinical Trials for LESCOL

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

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

See all LESCOL clinical trials

Paragraph IV (Patent) Challenges for LESCOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LESCOL Capsules fluvastatin sodium 20 mg and 40 mg 020261 1 2008-06-04

US Patents and Regulatory Information for LESCOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-001 Dec 31, 1993 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-002 Dec 31, 1993 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-001 Dec 31, 1993 ⤷  Sign Up ⤷  Sign Up
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-002 Dec 31, 1993 ⤷  Sign Up ⤷  Sign Up
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-002 Dec 31, 1993 ⤷  Sign Up ⤷  Sign Up
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-001 Dec 31, 1993 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for LESCOL

See the table below for patents covering LESCOL around the world.

Country Patent Number Title Estimated Expiration
Denmark 359284 ⤷  Sign Up
Hungary 9203780 ⤷  Sign Up
Austria 401870 ⤷  Sign Up
South Africa 8308718 ⤷  Sign Up
Cyprus 1994 Pharmaceutical compositions of pH at least 8 comprising an HMG-CoA reductase inhibitor ⤷  Sign Up
Australia 661075 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LESCOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0114027 96C0022 Belgium ⤷  Sign Up 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 ⤷  Sign Up SPC/GB93/173: 20031122, EXPIRES: 20080822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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