Mylan Pharmaceuticals Inc., a subsidiary of Mylan Inc. and Orion Corporation have entered into a settlement and license agreement settling the parties litigation in connection with Mylan's filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for Carbidopa/Levodopa/ Entacapone tablets, 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg.
This product is the generic version of Stalevo, which is indicated to treat patients with idiopathic Parkinson's disease to substitute (with equivalent strength of each of the three components) for immediate-release Carbidopa/Levodopa and Entacapone previously administered as individual products.
Under the terms of the settlement and license agreement, Mylan may launch an authorized generic version of Stalevo immediately and its own ANDA product upon receiving final FDA approval. Pursuant to the agreement, the parties pending litigation will be dismissed. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission.
For the 12 months ending March 31, 2013, Stalevo had US sales of approximately $138.6 million, according to IMS Health.
Currently, Mylan has 174 ANDAs pending FDA approval representing $83.2 billion in annual sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $23 billion in annual brand sales, for the 12 months ending Dec. 31, 2012, according to IMS Health.
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