Wednesday, April 9, 2008

Salix Receives Purported Notice of Paragraph IV Certification Against Patent for Moviprep

Apr 9, 2008 - Salix Pharmaceuticals, Ltd. today announced that the Company and its licensor, Norgine B.V., have received a purported notice of Paragraph IV Certification on behalf of Novel Laboratories, Inc. advising of the submission of an Abbreviated New Drug Application (ANDA) for MOVIPREP(R) (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution). Novel is a privately-held company that has been affiliated with Elite Pharmaceuticals, Inc.

Novel's letter alleges that U.S. Patent No. 7,169,381, owned by Norgine Europe B.V. and listed in the Orange Book for MOVIPREP, is invalid, unenforceable and/or will not be infringed by Novel's manufacture, use or sale of the product for which the ANDA is submitted. The expiration date for U.S. Patent No. 7,169,381 is September 1, 2024.

Salix has 45 days to commence a patent infringement lawsuit against Novel that would automatically stay, or bar, the U.S. Food and Drug Administration (FDA) from approving Novel's ANDA for up to 30 months or until a district court decision that is adverse to Salix, whichever may occur earlier.

Salix and Norgine have full confidence in the intellectual property rights that protect MOVIPREP. Moreover, Salix and Norgine intend to use all reasonable means at their disposal to vigorously defend MOVIPREP from any and all generic intrusion.

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