US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) on Friday confirmed that its subsidiary, Watson Laboratories, had filed an Abbreviated New Drug Application with the US Food and Drug Administration (FDA) seeking approval to market a copy version of German drug major Bayer’s (BAY: DE) oral contraceptive Beyaz (drospirenone and ethinyl estradiol and levomefolate calcium tablets, and levomefolate calcium).
Bayer HealthCare Pharmaceuticals Inc, Bayer Pharma AG, and Merck & Co filed suit against Watson on February 10, 2012, in the US District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of US Patent No 6,441,168. The law suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date the plaintiffs received notice of Watson's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Based on available information, Watson believes it may be a "first applicant" to file an ANDA for the generic version of Beyaz and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity in the USA.
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