Mylan Inc. has entered into a settlement agreement with Shionogi Inc. and CIMA Labs Inc. that will resolve patent litigation related to Prednisolone sodium phosphate orally disintegrating tablets (ODT), 10 mg, 15 mg and 30 mg.
Prednisolone sodium phosphate ODT is the generic version of Shionogi's Orapred ODT, which is indicated for the treatment of certain pulmonary diseases such as asthma. Additionally, the product is indicated for the control of certain severe or incapacitating allergic conditions, such as atopic dermatitis, and seasonal and perennial allergic rhinitis, that are intractable to adequate trials of conventional treatment.
According to the terms of the settlement, Mylan will be licensed to sell its Prednisolone sodium phosphate ODT product on April 1, 2014, or earlier under certain circumstances. Pursuant to the agreement, pending litigation will be dismissed. Other details of the settlement are confidential, and the agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission.
Mylan believes it was the first company to have filed a substantially complete abbreviated new drug application (ANDA) containing a Paragraph IV certification with the US Food and Drug Administration (FDA) for Prednisolone sodium phosphate ODT, 10 mg, 15mg and 30 mg, and anticipates that it will be entitled to 180 days of generic market exclusivity. This product had US sales of $33.1 million for the 12 months ending June 30, 2012, according to IMS Health.