Mylan in patent settlement with Shionogi over Orapred ODT

11 October 2012

US generic drugs major Mylan (Nasdaq: MYL) has entered into a patent settlement with Japan’s Shionogi (TYO: 4507) and its US unit CIMA Labs that will resolve patent litigation related to their Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) (ODT), 10mg, 15mg and 30mg, a 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. Under the agreement, pending litigation – which started in 2010 (The Pharma Letter December 20, 2010) -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.

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