Somaxon Pharmaceuticals Announces Settlement of Silenor Patent Litigation With Mylan and PAR
Somaxon Pharmaceuticals (NASDAQ: SOMX) announced Tuesday that it has entered into separate settlement arrangements with Mylan (NASDAQ: MYL) and its subsidiary, Mylan Pharmaceuticals, Inc. and Par Pharmaceutical Companies (NYSE: 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.
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