Somaxon, Actavis neurology news

Somaxon granted Actavis non-exclusive rights to sell a generic version of insomnia drug Silenor doxepin to settle litigation between the two companies. Actavis will have rights beginning January 1, 2020, or earlier under certain circumstances which include the U.S. sale of a third party's generic version of Silenor and a final court decision. In 2011, Somaxon filed suit in the U.S. District Court for the District of Delaware alleging that an ANDA filed by Actavis 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. Under the deal, Somaxon will make payments to Actavis in recognition of the costs and burden that Somaxon will save by avoiding the litigation. Specialty pharma Pernix Therapeutics Holdings Inc. (NYSE-M:PTX, the Woodlands, Texas) is acquiring Somaxon in stock deal that values the biotech at $25 million. The deal is expected to close this quarter (see BioCentury, June 13, 2011 & Dec. 17, 2012).

Last year, Somaxon granted Mylan Inc. (NASDAQ:MYL, Canonsburg, Pa.) exclusive rights to sell an authorized generic version of Silenor in the U.S. for 180 days beginning January 1, 2020. Mylan and Somaxon both have the right to terminate the supply agreement if another generic version of Silenor is launched in the U.S. Somaxon also granted Zydus Cadila Group (NSE:CADILAHC; BSE:532321, Ahmedabad, India) 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 (see BioCentury, July 23, 2012). ...