Warner Chilcott Company LLP sues Mylan Inc. and Famy Care Ltd. in connection with the filing of an Abbreviated New Drug Application (ANDA) with the US 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 US 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.
Mylan Inc. is the leading generic and specialty pharmaceutical companies in the world, focused on respiratory, allergy and psychiatric therapies.