Mylan Inc. and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Somaxon Pharmaceuticals, Inc. that will resolve the parties' patent litigation in connection with Mylan's Abbreviated New Drug Application (ANDA) for Doxepin hydrochloride tablets, 3 mg and 6 mg, which is the generic version of Somaxon's Silenor, indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.
According to the terms of the settlement agreement, Mylan has the exclusive right to sell an authorized generic version of Silenor in the US and its territories for 180 days beginning on January 1, 2020. In certain limited circumstances, Somaxon's license to Mylan would become effective prior to January 1, 2020. Mylan's right to sell the authorized generic product could extend for as long as 360 days, and after such period Mylan will have the right to sell a generic version of Silenor under its own ANDA. Pursuant to the agreement, the pending litigation will be dismissed. Additionally, Mylan entered into an agreement to manufacture and supply Silenor finished product to Somaxon.
Other details of the settlement are confidential, and the agreements are subject to review by the Federal Trade Commission and the US Department of Justice.