Tuesday, May 13, 2008

Barr gets nod for contraceptive generic (Yasmin)

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.

The details can be read here.

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