Somaxon, Mylan, Zydus deal

Somaxon granted Mylan exclusive rights to sell an authorized generic version of insomnia drug Silenor doxepin in the U.S. for 180 days beginning January 2020. Under undisclosed circumstances, Mylan's right to sell the authorized generic may extend for up to 360 days, and after such period Mylan will have the right to sell the generic under its own ANDA. Somaxon also granted Zydus rights to sell a generic version of Silenor beginning 180 days after a third party's generic version is first sold in the U.S. under a license from Somaxon or a final court decision. Both deals are part of settlements to resolve litigation filed in 2011 by Somaxon separately in the U.S. District Court for the District of Delaware, which alleged that ANDAs filed by Mylan and Zydus for generic versions of 3 and 6 mg Silenor infringed U.S. Patent Nos. 6,211,229 and 7,915,307. The '229 patent covers 0.5-20 mg Somaxon for transient insomnia and expires in February 2020. The '307 patent covers methods of improving the pharmacokinetics of doxepin and expires on Aug. 24, 2027. The ANDAs contain paragraph IV certifications that the patents are invalid, unenforceable and/or not infringed (see BioCentury, June 13, 2011). ...