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news.Bayer HealthCare Pharmaceuticals, Bayer Pharma, and Merck & Cie have filed suit against Watson Pharmaceuticals in the US District Court for the District of Delaware over patent for Beyaz birth control pill.?
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The lawsuit seeks to prevent Watson from commercializing its product prior to the expiration US patent number 6,441,168.
Watson Pharmaceuticals has confirmed that Watson Laboratories has filed an ANDA with FDA to market Drospirenone and Ethinyl Estradiol and Levomefolate calcium tablets, 3mg/0.02mg/0.451mg and Levomefolate calcium tablets, 0.451mg.
The ANDA product is a generic version of Bayer HealthCare Pharmaceuticals’ Beyaz, an oral contraceptive.
Beyaz is indicated to treat symptoms of premenstrual dysphoric disorder (PMDD), moderate acne and raise folate levels in women who choose to use an oral contraceptive for contraception.
Watson believes it may be the first applicant to file an ANDA for generic Beyaz and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.