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news.Barr Pharmaceuticals has announced that its wholly owned subsidiary, Barr Laboratories, has entered into supply and licensing agreements with Bayer for generic versions of Bayer's Yasmin and Yaz oral contraceptive products.
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Under terms of these agreements, Bayer will supply Barr with the generic products for launch prior to the expiration of the patents protecting these products and Barr will have sole responsibility to market, sell and distribute the products in the US under the Barr Laboratories label.
Under the Yasmin agreement, Bayer will supply Barr with an authorized generic version of Yasmin for launch on or before July 1, 2008, several years earlier than the last-to-expire Bayer patent listed in the FDA’s orange book. Barr will pay Bayer an undisclosed supply price for the product. Barr also has an additional undisclosed profit split with Gedeon Richter, its development partner for generic Yasmin.
Under a separate agreement, Bayer will supply Barr with an authorized generic version of Yaz for launch on July 1, 2011, or earlier in certain circumstances. Barr will pay Bayer an undisclosed supply price for the product.
On March 3, 2008 Barr announced that the US District Court of New Jersey had ruled in favor of its subsidiary, Barr Laboratories, in the challenge of the patent listed by Bayer’s Yasmin product. On April 1, 2008, Bayer appealed this ruling to the US Court of Appeals for the federal circuit. Under the licensing agreements, Barr will continue to be able to sell generic versions of Yasmin and Yaz regardless of the outcome of Bayer’s appeal.