Actavis plc announced that it has entered into an agreement with Mylan Inc. and Famy Care Ltd. to settle all outstanding patent litigation related to Mylan’s generic version of Generess FE (norethindrone, ethinyl estradiol and ferrous fumarate chewable tablets).
Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generess FE under its pending Abbreviated New Drug Application (ANDA) beginning on April 1, 2015.
Alternatively, Mylan will be permitted to launch an authorized generic version of Actavis’ product beginning on Oct. 1, 2015. Other terms of the settlement were not disclosed. Actavis remains in litigation with Lupin Ltd. in connection with Lupin’s pending ANDA for a generic version of Generess.
Date: April 15, 2014
Filed Under: Drug Discovery