Watson’ Subsidiary Files ANDA To Market Armodafinil Tablets

Watson Pharmaceuticals has confirmed that its subsidiary, Watson Laboratories has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market its 50mg, 100mg, 150mg, 200mg, and 250mg strength Armodafinil tablets, prior to the expiration of patents owned by Cephalon France.

Watson’s 50mg, 100mg, 150mg, 200mg and 250mg Armodafinil tablet products are generic versions of Cephalon’s Nuvigil. It 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.

Moreover, Cephalon 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 7132570. Cephalon’s suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final 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 100mg and 200mg 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.