Barr Pharmaceuticals, announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic version of Yasmin (drospirenone and ethinyl estradiol), an oral contraceptive product manufactured and marketed by Bayer Schering Pharma, AG.
On March 3, 2008 Barr announced that the US District Court for the district of New Jersey had ruled in favour of its subsidiary, Barr Laboratories Inc., in the challenge of the patent listed by Bayer Schering Pharma, AG for its Yasmin product. In his ruling, Judge Peter G Sheridan found that the patent at issue was invalid, because it was obvious. On April 1, 2008, Bayer Schering appealed this ruling to the US Court of appeals for the Federal Circuit.
Yasmin is a 28-day oral contraceptive consisting of 21 active tablets each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol and 7 inert tablets. Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. The product had annual sales of approximately $575 million for the twelve months ended February 2008, based on IMS sales data.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.