Mylan sued by Shionogi and CIMA over Orapred patent challenge

US generics major Mylan (Nasdaq: MYL) has confirmed that, along with its subsidiary Mylan Pharmaceuticals, it been sued by Japanese drugmaker Shionogi’s (TKO: 4507) US unit and CIMA Labs (which provide the drug delivery technology) in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for a copy version of their Orapred ODT (prednisolone sodium phosphate) orally disintegrating tablets, 10mg, 15mg and 30mg. The product is 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 specified strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. Shionogi and CIMA filed the law suit in the US District Court for the District of Delaware.

Orapred ODT had US sales of around $28 million for the 12 months ending September 30, 2010, according to IMS Health. Currently, Mylan has 164 ANDAs pending FDA approval representing $98.9 billion in annual sales, according to IMS Health. 45 of these pending ANDAs are potential first-to-file opportunities, representing $24 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.