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Warner Chilcott, Lupin settle Loestrin 24 Fe, Femcon Fe patent litigations

Warner Chilcott and its subsidiary Warner Chilcott Company, and Lupin and its subsidiary Lupin Pharmaceuticals have entered into a settlement agreement to resolve pending patent litigations involving Warner Chilcott's oral contraceptive products Loestrin 24 Fe and Femcon Fe.

Under the terms of the settlement agreement, Lupin has agreed that, except in the event of an at-risk launch by a third-party of a generic Loestrin 24 Fe product, neither Lupin nor its affiliates will market or sell a generic Loestrin 24 Fe product prior to July 22, 2014.

In the event of such an at-risk launch by Lupin, Warner Chilcott has reserved its right to bring an infringement suit against Lupin and pursue all legally available remedies.

In addition, Warner Chilcott has granted Lupin a non-exclusive license covering Femcon Fe, which will permit Lupin to commence marketing either an authorized generic product, which would be supplied by Warner Chilcott, or generic equivalent of Femcon Fe in the US beginning on the earlier of 180 days after the date that Teva Pharmaceutical Industries, enters the market with a generic equivalent to Femcon Fe, or 1 January 2013.

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

The final settlement remains subject to certain conditions specified in the settlement agreement, including the court’s ordering the stipulations of dismissal.

Warner Chilcott is a specialty pharma company currently focused on the gastroenterology, women’s healthcare, dermatology and urology segments of the North American and Western European pharmaceuticals markets. It is integrated with internal resources dedicated to the development, manufacturing and promotion of its products.