Somaxon Pharmaceuticals Announces Settlement of Silenor Patent Litigation With Mylan and PAR

Somaxon Pharmaceuticals SOMX announced Tuesday that it has entered into separate settlement arrangements with Mylan MYL and its subsidiary, Mylan Pharmaceuticals, Inc. and Par Pharmaceutical Companies PRX and its subsidiary Par Pharmaceutical, Inc. to resolve pending patent litigation involving Silenor 3 mg and 6 mg tablets. The settlement agreement with Mylan grants Mylan the exclusive right to begin selling an authorized generic version of Silenor (i.e., a generic version sold under Somaxon's New Drug Application) on January 1, 2020, or earlier under certain circumstances. Mylan's right to sell such an authorized generic product could extend for a period of as long as 360 days, and after such period Mylan will have the non-exclusive right to sell a generic version of Silenor under its Abbreviated New Drug Application. In connection with the settlement agreement, the parties also entered into a supply agreement under which Mylan has agreed to supply the company with commercial quantities of Silenor 3 mg and 6 mg tablets. The settlement agreement with Par grants Par the right to begin selling a generic version of Silenor 180 days after the earlier of the date that a third party's generic version of Silenor is first sold in the United States under a license from Somaxon or a final court decision that the asserted patents are not infringed, invalid or unenforceable, or earlier under certain circumstances.