FDA approves Barr's generic Yasmin

MONTVALE, N.J. Barr Laboratories has received approval from the Food and Drug Administration for its application to manufacture and market a generic version of Yasmin, drospirenone and ethinyl estradiol, an oral contraceptive product manufactured and marketed by Bayer Schering Pharma.

On March 3, Barr announced that the District Court for the District of New Jersey had ruled in favor of its subsidiary, Barr Laboratories in the challenge of the patent listed by Bayer Schering Pharma, AG for Yasmin. In his ruling, Judge Peter G. Sheridan found that the patent at issue was invalid, because it was obvious. On April 1, Bayer Schering appealed this ruling to the U.S. Court of Appeals for the Federal Circuit.

The product had annual sales of approximately $575 million for the twelve months ended February 2008, based on IMS sales data.