Vanda Expands Efforts to Pull Two Hetlioz Copies From US Shelves

Vanda Pharmaceuticals Inc. expanded its efforts to get Apotex Inc. and Teva Pharmaceuticals Industries Ltd.’s generic versions of its Hetlioz sleep-disorder drug pulled from US shelves, alleging in two federal lawsuits that the copies infringe a patent issued in March.

Both generics infringe US Patent No. 11,918,556, which covers methods of treating circadian rhythm disorders with tasimelteon, Hetlioz’s active ingredient, according to complaints filed Monday against Apotex and against Teva in the US District Court for the District of Delaware. Hetlioz is used to treat two rare circadian-rhythm disorders: non-24-hour sleep-wake disorder and nighttime sleep disturbances in the genetic ...