Watson seeks FDA approval for sleep disorder treatment
MORRISTOWN, N.J. Watson has filed an abbreviated new drug application for the generic version of a sleep disorder treatment.
Watson said is seeks approval for market its 50-mg, 100-mg, 150-mg, 200-mg, and 250-mg strength armodafinil tablets prior to the expiration of patents owned by Cephalon France. Watson's drug is the generic version of Nuvigil, which is indicated for the improvement of wakefulness in adults who experience excessive sleepiness associated with treated obstructive sleep apnea, shift work sleep disorder, also known as shift work disorder, or narcolepsy.
Cephalon and Cephalon France filed suit against Watson on Jan. 5, 2010 in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration its patent. Based on available information, Watson said it believes it may be a "first applicant" to file an ANDA for the 100-mg and 200-mg strengths of a generic version of Nuvigil and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity for those strengths.
For the twelve months ended Sept. 30, 2009, Nuvigil had total U.S. sales of approximately $42 million according to IMS Health data.