Mylan Pharmaceuticals and Orion have entered into a settlement and license agreement, which dismisses the parties pending litigation related to Mylan's filing of an Abbreviated New Drug Application (ANDA) with the US FDA for the generic version of Stalevo.
Carbidopa/Levodopa/Entacapone tablets, 12.5mg/50mg/200mg, 18.75mg/75mg/200mg, 25mg/100mg/200mg, 31.25mg/125mg/200mg, 37.5mg/150mg/200mg, and 50mg/200mg/200mg is indicated to treat patients with idiopathic Parkinson's disease.
As per the terms of the agreement, after the receipt of final FDA approval Mylan may launch an authorized generic version of Stalevo immediately and its own ANDA product.
The agreement is subject to review by the US Department of Justice and the Federal Trade Commission, while other terms and conditions of the same remain confidential.
Stalevo had sales of nearly $138.6m in the US for the 12 months ending on 31 March 2013, according to IMS Health.
Currently, about 37 out of 174 ANDAs pending FDA approval are potential first-to-file opportunities, representing $23bn in annual brand sales, for the 12 months ending 31 December 2012, according to IMS Health.
