Mylan Confirms First-to-File Patent Challenge Relating to Orapred ODT

Mylan Inc. MYL today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Shionogi Pharma Inc. and CIMA LABS INC. in connection with the filing of an Abbreviated New Drug Application with the U.S. Food and Drug Administration for Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg and 30 mg. This product is the generic version of Orapred ODT, a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for the treatment of certain endocrine conditions and for palliation of certain neoplastic conditions.