Watson Pharmaceuticals, Inc, a leading global specialty pharmaceutical company, confirmed that its subsidiary, Watson Laboratories, Inc, a Nevada Corporation, filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration seeking approval to market its 50 mg, 100 mg, 150mg, 200 mg, and 250mg strength armodafinil tablets prior to the expiration of patents owned by Cephalon France. Watson's 50 mg, 100 mg, 150mg, 200 mg and 250mg armodafinil tablet products are generic versions of Cephalon, Inc.'s Nuvigil, which is indicated for the improvement of wakefulness in adults who experience excessive sleepiness (ES) associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), or narcolepsy.
Cephalon, Inc. and Cephalon France filed suit against Watson on January 5, 2010 in the US District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of US Patent No. 7,132,570. Cephalon's suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final US FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Based on available information, Watson 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 ending September 30, 2009, Nuvigil had total US sales of approximately US$ 42 million according to IMS Health data.