Mylan Inc. today announced that Mylan Specialty L.P., f/k/a Dey Pharma, L.P., has entered into a settlement agreement with Sunovion Pharmaceuticals Inc., f/k/a Sepracor Inc., that will resolve the parties’ patent litigation in connection with Mylan Specialty’s Abbreviated New Drug Application (ANDA) for Levalbuterol Hydrochloride (HCl) Inhalation Solution, 0.31 mg/3 mL, 0.63 mg/3 mL, 1.25 mg/3 mL and 1.25 mg/0.5mL. Levalbuterol HCl is the generic version of Sunovion’s Xopenex product.
According to the terms of the settlement, Mylan Specialty is licensed to continue sales of its concentrate product (Levalbuterol HCl 1.25 mg/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) upon receiving final approval from the U.S. Food and Drug Administration. The settlement also releases Mylan from payment of the $18 million jury damage award to Sunovion.
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 U.S. Department of Justice and the Federal Trade Commission.