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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Dow
Argus Health
Queensland Health
Express Scripts
Julphar
Chubb
Johnson and Johnson
Moodys

Generated: May 23, 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.

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.

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
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 2007-03-15

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 ➤ Try a Free Trial
8,303,987 Pharmaceutical compositions comprising fluvastatin ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for LESCOL XL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022 Belgium ➤ Try a Free Trial 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 hundreds of leading biopharmaceutical companies globally:

Argus Health
Harvard Business School
Farmers Insurance
Boehringer Ingelheim
Moodys
Daiichi Sankyo
Accenture
Express Scripts
Merck

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