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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Johnson and Johnson
Mallinckrodt
Healthtrust
Deloitte
Chinese Patent Office
Federal Trade Commission
Fuji
Fish and Richardson

Generated: January 16, 2018

DrugPatentWatch Database Preview

LESCOL XL Drug Profile

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When do Lescol Xl patents expire, and what generic alternatives are available?

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 and one supplementary protection certificate in one country.

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.
Summary for LESCOL XL
Drug patent expirations by year for LESCOL XL
Pharmacology for LESCOL XL

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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Paragraph IV (Patent) Challenges for LESCOL XL
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 80 mg ➤ Subscribe 3/15/2007

Non-Orange Book US Patents for 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
8,303,987 Pharmaceutical compositions comprising fluvastatin ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for LESCOL XL

Supplementary Protection Certificates for LESCOL XL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022 Belgium ➤ Subscribe PRODUCT NAME: FLUVASTATINE SODIQUE; NAT. REGISTRATION NO/DATE: 151 IS 207 F 4 19960409; FIRST REGISTRATION: GB 0101/0360 19930823
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Novartis
Mallinckrodt
Chinese Patent Office
QuintilesIMS
Teva
Federal Trade Commission
Medtronic
Argus Health
Merck

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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