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Barr's Nortel 7/7/7 oral contraceptive gets final approval

POMONA, N.Y., September 4, 2002 -- Barr Laboratories announced that the FDA has granted final approval of its application to manufacture and market a generic version of Ortho-McNeil Pharmaceutical's Ortho-Novum 7/7/7 oral contraceptive.

The company plans to launch its generic version in January 2003, nine months ahead of expiration of the Ortho-Novum 7/7/7 patents, under a non-exclusive license granted by Ortho-McNeil Pharmaceutical, that resulted from a settlement of pending litigation.

Under the terms of the agreement that was reached in October 2001, Ortho-McNeil granted Barr a non-exclusive license effective January 1, 2003, nine months before the patents protecting the product expire in September 2003. As part of the settlement, Barr acknowledged its infringement of, and the validity and enforceability of, the patent claims at issue in the case.

Ortho-Novum 7/7/7 is a regimen of oral contraceptives that includes three different tablet combinations of norethindrone and ethinyl estradiol. The product comes in 21 tablet and 28 tablet packaging. Ortho-Novum 7/7/7 had most recent annual sales of approximately $147 million.

Source: Barr Laboratories

Posted: September 2002