Barr Laboratories Inc has reached a settlement of pending litigation regarding Ortho-McNeil Pharmaceutical Inc's patents protecting Ortho Tri-Cyclen oral contraceptive. Under the terms of the settlement, Barr will be permitted to introduce a generic product no later than December 29, 2003. The Company reported that it will launch its generic version of Ortho Tri-Cyclen earlier than December 29, 2003, if Ortho-McNeil fails to file with the U.S. Food and Drug Administration (FDA) for pediatric exclusivity prior to patent expiry on September 26, 2003 or files and the FDA denies its request. As part of the settlement, Barr acknowledged its infringement of, and the validity and enforceability of, the patent claims at issue in the case.

"This settlement guarantees Barr the right to launch our generic Ortho Tri-Cyclen product at least three months earlier than would have been permitted if Ortho McNeil had won the patent litigation and been granted six months of pediatric exclusivity," said Bruce L. Downey, Barr's Chairman and CEO.

Ortho Tri-Cyclen is a regimen of oral contraceptives that includes three different tablet combinations of norgestimate and ethinyl estradiol and is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. The product comes in 28-tablet packaging. The product had annual sales of approximately $713 million for the twelve months ending May 2003.