Mylan has reached a settlement in a patent litigation suit filed by Sunovion Pharmaceuticals concerning Mylan Specialty's abbreviated new drug application for Levalbuterol Hydrochloride (HCl) Inhalation Solution, 0.31mg/3 mL, 0.63mg/3 mL, 1.25mg/3 mL and 1.25mg/0.5mL.
Under the terms of the settlement, pending litigation will be dismissed and Mylan is released from the payment of the $18m jury damage award to Sunovion.
Mylan Specialty can continue to sell its concentrate product, Levalbuterol HCl 1.25mg/0.5mL and will have a royalty-bearing license to sell the nonconcentrate version in the 0.31mg/3 mL, 0.63mg/3 mL and 1.25mg/3 mL strengths, once FDA approves.
Remaining details of the agreement were not disclosed and the agreement is subject to review by the US Department of Justice and the Federal Trade Commission.
Levalbuterol HCl is the generic version of Sunovion's Xopenex product.
