Warner Chilcott sues Mylan, Famy Care over Generess Fe patent challenge
PITTSBURGH — Generic drug maker Mylan and a partnering company are challenging the patent on a contraceptive drug.
Mylan said Thursday that it and Famy Care had been sued by Warner Chilcott in the U.S. District Court for the District of New Jersey following their filing of a regulatory approval application with the Food and Drug Administration for norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets, a generic version of Warner Chilcott's Generess Fe.
The application contains a paragraph IV certification, a legal assertion that patents covering Generess Fe are invalid, unenforceable or won't be infringed. Between its April 2011 launch and Sept. 30, Generess Fe had sales of $4.5 million, according to IMS Health.