Barr Laboratories Inc has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) for Cephalon Inc's Provigil (Modafinil), 100 mg and 200 mg Tablets on December 24, 2002, the first day that Barr was legally entitled to file. The Company indicated that it believes that it is one of several companies to file an application challenging Cephalon's patents on that date. Earlier today Cephalon announced that it had filed a lawsuit in U.S. District Court in New Jersey against four generic pharmaceutical companies, including Barr, for infringement of Cephalon's patents protecting Provigil 100 mg and 200 mg Tablets from generic competition.

Provigil is indicated to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.

Barr filed an ANDA for Provigil 100 mg and 200 mg Tablets with the FDA on December 24, 2002, and received notification of the application's acceptance for filing in early February 2003. Following receipt of notice from FDA, Barr notified Cephalon in mid February 2003 of Barr's challenge to Cephalon's patents asserting that Barr's products do not infringe. Barr has not yet received notification from Cephalon that it has formally initiated the patent challenge process.

Provigil has annual sales of approximately $217 million for the twelve months ending January 2003.