Novel Lab challenged Moviprep Orange book listed patent US7169381

Drug developer Salix Pharma announced that Novel Laboratories is challenging the patent (US7169381) on the company's bowel cleansing drug Moviprep. The following patent is listed in Orange book for Moviprep
US7169381 (Expiry: Sep 1, 2024)- Which covers a dry composition for admixture with water wherein the dry composition comprises, per liter of aqueous solution to be made, the following components, the components of the composition being selected such that an aqueous solution made up to 1 liter has an osmolarity within the range of from 300 to 700 mOsmol/kg: a) 80 to 350 g polyethylene glycol; b) 3 to 20 g a mixture of ascorbic acid and one or more salts of ascorbic acid; c) 1 to 15 g of an alkali metal or alkaline earth metal sulphate or a mixture of alkali metal or alkaline earth metal sulphates; and d) optionally one or more electrolytes selected from sodium chloride, potassium chloride and sodium hydrogen carbonate.
FDA approved in August 2006, MoviPrep® (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution), provides the efficacy of a 4 liter polyethylene glycol (PEG) lavage in a tolerable lower volume. MoviPrep is the only PEG lavage with ascorbic acid and sodium ascorbate to increase stool volume and enhance taste. MoviPrep is indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. MoviPrep offers a tolerable dosing regimen that does not require the use of bisacodyl tablets, thereby avoiding bisacodyl-associated abdominal cramping in patients. The drug is licensed to Salix by Netherlands-based Norgine B.V., which is privately held. The company said privately held Novel asked the Food and Drug Administration to approve a generic version of the drug, alleging that the current patent is invalid and unenforceable. Salix now has 45 days to file a patent infringement lawsuit against Novel to bar the USFDA from approving a generic version of Moviprep for up to 30 months or until court decision.