Somaxon Pharmaceuticals (SOMX) has entered into separate settlement arrangements with Mylan (MYL) and its subsidiary, Mylan Pharmaceuticals, and Par Pharmaceutical Companies and its subsidiary Par Pharmaceutical, 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 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. 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 U.S. 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.
- Par Pharmaceutical