Barr Pharmaceuticals, Inc announced that its subsidiary, Barr Laboratories, Inc., has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic version of Warner Chilcott Company, Inc.'s Estrostep Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets) oral contraceptive product.
The company will launch its product immediately under the tradename TriLegest Fe. The company's generic oral contraceptive portfolio will now contain 25 products.
In April 2004, Warner Chilcott and Barr entered into an agreement to settle patent litigation under which Warner Chilcott granted Barr a non- exclusive license to launch a generic version of Estrostep Fe in October 2007, six months prior to the last patent expiration on Estrostep Fe.
Estrostep Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Estrostep Fe is also indicated for the treatment of moderate acne vulgaris in females, .15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Estrostep Fe should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months.
Estrostep Fe had annual sales of approximately $110 million for the twelve months ending August 2007, based on IMS data.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.