US patent settlements of Xopenex and Lidoderm

US generics drug major Mylan (Nasdaq: MYL) has entered into a settlement agreement with Sunovion Pharmaceuticals, a unit of Japanese drugmaker Dainippon Sumitomo Pharma (4506: JP), that will resolve the parties' patent litigation in connection with Mylan Specialty's Abbreviated New Drug Application for levalbuterol hydrochloride inhalation solution, 0.31mg/3mL, 0.63mg/3mL, 1.25g/3mL and 1.25mg/0.5mL, a generic version of Sunovion's Xopenex which is indicated for the treatment or prevention of bronchospasm.

According to the terms of the settlement, Mylan Specialty is licensed to continue sales of its concentrate product (levalbuterol HCl 1.25mg/0.5mL) and will have a royalty-bearing license to sell its non-concentrate product (levalbuterol HCl 0.31mg/3mL, 0.63mg/3mL and 1.25mg/3mL) on receiving final approval from the US Food and Drug Administration. The settlement also releases Mylan from payment of the $18 million jury damage award to Sunovion.

As a result of 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.