Mylan Inc. 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 (ANDA) with the US Food and Drug Administration (FDA) 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 neo-plastic conditions.
Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the 10 mg, 15 mg and 30 mg strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. Shionogi Pharma and CIMA LABS filed the lawsuit in the US District Court for the District of Delaware.
Orapred ODT had US sales of approximately $28 million for the 12 months ending Sept. 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. Forty-five 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.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.