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Generated: March 20, 2019

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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. Five 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 Date
➤ Subscribe Extended-release Tablets 80 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for LESCOL XL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0114027 96C0022 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
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Medtronic

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