Warner Chilcott sues Watson over Lo Loestrin; Actavis debuts generic Requip

20 May 2012

Ireland-headquartered Warner Chilcott (Nasdaq: WCRX) has filed suit against USA-based Watson Pharmaceuticals (NYSE: WPI) on May 16, in the US District Court for the District of New Jersey seeking to prevent Watson from commercializing its Abbreviated New Drug Application for it contraceptive product prior to the expiration of US Patent Nos 5,552,394 and 7,704,984.

Watson confirmed that it has filed an ANDA with the US Food and Drug Administration seeking approval to market norethindrone acetate/ethinyl estradiol and ethinyl estradiol and ferrous fumarate tablets,1mg/0.01mg and 0.01mg and 75mg, a generic version of Warner Chilcott’s Lo Loestrin, indicated for the prevention of pregnancy.

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 plaintiff 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.

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