Bayer, Barr Sign Agreements For Generic Version Of Oral Contraceptives Yasmin, YAZ

Main Category: Sexual Health / STDs
Also Included In: Women's Health / Gynecology;  Pharma Industry / Biotech Industry
Article Date: 26 Jun 2008 - 8:00 PST

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Bayer Schering on Tuesday announced that it has entered into two agreements with Barr Pharmaceuticals to supply Barr with generic versions of its oral contraceptives Yasmin and YAZ to market in the U.S., the AP/International Herald Tribune reports (AP/International Herald Tribune, 6/24). Yasmin is a low-dose birth control pill approved by the FDA in May 2001 (Thomson Financial/Forbes, 6/24). YAZ is a newer formulation of Yasmin that FDA has approved as a birth control method, as a treatment for moderate acne in women, and as a treatment for premenstrual dysphoric disorder, a severe form of premenstrual syndrome (Bayer release, 1/29/07).

Under the first agreement, Barr will market and sell the generic version of Yasmin in the U.S. starting on or before July 1, 2008 (AP/International Herald Tribune, 6/24). According to a joint release, Bayer will supply Barr with the generic version of Yasmin prior to the expiration of the company's patent in the U.S. Under the second agreement, Bayer agreed to grant Barr a license to market and sell a generic version of YAZ starting July 1, 2011, or earlier (Joint release, 6/24). Barr will pay Bayer a fixed percentage of the revenues from both the products, but further financial details of the two agreements were not disclosed, the AP/Herald Tribune reports (AP/International Herald Tribune, 6/24).

Bayer on Tuesday also announced that it will continue to pursue its appeal of a federal court decision in New Jersey that invalidated its patent on Yasmin. Based on the agreement, Bayer still will receive a share of the profits from Barr even if Bayer fails to defend its patent in court. In addition, the agreement states that if Bayer successfully defends its patent, Barr will retain its power to market, sell and distribute Yasmin in the U.S. but will have to pay higher royalties to Bayer (Thomson Financial/Forbes, 6/24).

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