Mylan Inc. (Nasdaq: MYL) today confirmed that it and Famy Care Ltd. have been sued by Warner Chilcott Company LLP, in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Norethindrone and Ethinyl Estradiol Chewable Tablets, 0.8 mg/0.025 mg and Ferrous Fumarate Chewable Tablets. This product is the generic version of Generess™ Fe, a 28-day regimen indicated for use by women to prevent pregnancy.
Mylan believes that this application submitted to the FDA is the first substantially complete ANDA containing a Paragraph IV certification and expects it to qualify for 180 days of marketing exclusivity upon final approval. In 2008, Mylan and Famy Care entered into a partnership to develop and supply oral contraceptives. Warner Chilcott filed the lawsuit in the U.S. District Court for the District of New Jersey.
Since launching in April 2011 and through Sept. 30, 2011, Generess Fe had sales of $4.5 million, according to IMS Health.