Mylan confirms patent challenge to Generess Fe; launches Caduet copy in USA

US generic drug major Mylan (Nasdaq: MYL) yesterday confirmed that it and Famy Care have been sued by Warner Chilcott in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for norethindrone and ethinyl estradiol 0.8mg/0.025mg 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. The product is marketed in the USA by Watson Pharmaceuticals and, since launching in April 2011 and through September 30, 2011, Generess Fe had sales of $4.5 million, according to IMS Health.
The US patent for the product expires in 2019, according to Warner Chilcott. However, Mylan claims that the patent “is purportedly invalid, unenforceable, and or will not be infringed” by the generic product.

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 law suit in the US District Court for the District of New Jersey.