Generic Estrostep poised to break into U.S. market

ROCKAWAY, N.J. Under a supply agreement between Warner Chilcott Co. and Watson Pharmaceuticals, generic drug maker Watson will supply Tilia Fe, the generic of Warner Chilcott’s popular oral contraceptive Estrostep FE.

Under the terms of the agreement, Warner Chilcott will supply Tilia (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets) to Watson Pharma, which will be responsible for the marketing, sales and distribution of the generic product in the United States. Warner Chilcott will receive a share of the profits.

Meanwhile, Barr Laboratories received approval from the Food and Drug Administration for its abbreviated new drug application to manufacture and market its own generic version of Estrostep.

Once Barr launches its product, which will be named TriLegest Fe, its generic oral contraceptive portfolio will contain 25 products, the company said.

In April 2004, Warner Chilcott and Barr entered an agreement to settle patent litigation under which Barr was granted a nonexclusive license to launch a generic version of Estrostep in October 2007, six months prior to the last patent expiration on the drug.