Shionogi Pharma and CIMA LABS filed the lawsuit in the US District Court for the District of Delaware.
The 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.
Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the 10mg, 15mg and 30mg strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval.