Barr Laboratories Inc has received tentative approval from the U.S. Food & Drug Administration (FDA) for its generic version of Kos Pharmaceutical Inc's Niaspan 1000 mg Extended-Release Tablets (Niacin Extended-Release Tablet). The Company is currently challenging the validity and/or infringement of certain patents held by Kos for Niaspan 1000 mg Extended-Release Tablets and a trial in the Federal District Court in New York is currently scheduled for December 2004.

In December 2001, Barr received notice from the U.S. Food and Drug Administration (FDA) that its Abbreviated New Drug Application (ANDA) for Niacin Extended-Release Tablets had been accepted for filing in November 2001. Following receipt of notice from FDA, Barr notified Kos, who owns the three patents listed for Niaspan. On March 4, 2002, Kos announced that it had filed suit in Federal Court in New York to prevent Barr from proceeding with the commercialization of this product. This action formally initiated the patent challenge process. Barr believes that it is the first to file its application for the product.

Niacian 1000 mg Extended-Release Tablets has tentative approval for use as an adjunct to diet and other non-pharmacologic measures for reduction of elevated cholesterols in patients when the response to an appropriate diet and other non-pharmacologic measures has been inadequate. Cases of severe hepatic toxicity have occurred in patients who have substituted extended release tablets for immediate release tablets. Liver disease or patients who use substantial quantities of alcohol may preclude use.

Niaspan 1000 mg Extended-Release Tablets had annual sales of approximately $70 million for the twelve months ended March 2003.