Watson Sued by Cephalon Over Nuvigil Patent

Cephalon has sued Watson Pharmaceuticals alleging patent infringement on the company’s sleep disorder drug Nuvigil. Watson’s filing of an ANDA in November to make a generic Nuvigil (armodafinil) infringes Cephalon’s ’570 patent, according to the suit filed last week in the U.S. District Court for the District of Delaware. The drug is approved to treat excessive sleepiness associated with obstructive sleep apnea, hypopnea syndrome, narcolepsy and shift work. Cephalon filed suit under the provisions of the Hatch-Waxman Act, which will delay final FDA approval of the ANDA for as long as 30 months or until final resolution of the lawsuit, Watson said.
Washington Drug Letter