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Bayer on Friday filed a lawsuit in a US District Court in Delaware seeking to block Watson from selling a generic version of Bayer’s Beyaz oral contraceptive. Watson filed for FDA approval of its version of the drug, which combines the oral contraceptive, Yaz (estrogen/progestin), with a folate supplement, on Friday and said it believes it is the first to submit an application.
However, Bayer asserts that the product is protected by an existing patent and has asked a judge to ban the sale of any Watson birth control product based on the patent. Watson spokesman Charlie Mayr said his company plans to challenge the validity of the patent.
Beyaz garnered US approval in 2010 and had total US sales of approximately $97 million for the year ending December 31.