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Warner Chilcott settles contraceptives suit

Warner Chilcott has signed a settlement agreement with Lupin Pharmaceuticals to resolve patent litigation over two oral contraceptives

Warner Chilcott has signed a settlement agreement with Lupin Pharmaceuticals to resolve patent litigation over the oral contraceptives Loestrin 24 Fe and Femcon FE.

Warner filed patent infringement lawsuits against Lupin last year after Lupin submitted two Abbreviated New Drug Applications (ANDA) to the US Food and Drug Administration (FDA) seeking approval to launch generic versions of the oral contraceptives before the July 2014 expiration of Warner's Loestrin 24 Fe (norethindrone acetate and ethinyl estradio) patent protection and the April 2010 expiration of the patent protection on Femcon FE.

The settlement agreement calls for Lupin to hold off on launching a generic version of Loestrin 24 until July 22, 2010, except in the event of a pending launch of the product by another generic manufacturer. If Lupin does launch a generic version of Loestrin 24 in the face of a launch by a generic competitor, Warner has reserved its right to bring an infringement suit against Lupin.

The settlement also grants Lupin a non-exclusive licence to Femcon Fe allowing the company  to begin selling either an authorised generic product, which would be supplied by Warner, or another generic equivalent in the US beginning 180 days after Teva Pharmaceutical launches a generic version or on January 1, 2013, whichever comes first. An earlier settlement between Teva and Warner allows Teva to launch its generic on July 1, 2012 or two years following the date of the filing of an abbreviated new drug application containing a paragraph IV patent challenge by another generic competitor, whichever comes first.

Warner Chilcott has also granted Lupin the rights to purchase and sell an authorised generic version of the ulcerative colitis drug Asacol 400mg, which would be supplied by Warner Chilcott, only if a generic version of the Asacol 400mg product is launched in the US by another generic manufacturer.

15th October 2010

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