Mylan settles over generic Generess tablets and launches insomnia drug

US generics major Mylan (Nasdaq: MYL) and its partner Famy Care have entered into a settlement and license agreement settling litigation over Mylan’s filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration for norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets.

The parties have resolved the litigation with Warner Chilcott, which was bought by generics major Actavis (NYSE: ACT) last year, over the generic version of Generess Fe Tablets, which are indicated for the prevention of pregnancy.

Under the terms of the settlement and license agreement, Mylan may begin to sell a generic version of Generess Fe Tablets on April 1, 2015, or earlier under certain circumstances, and upon receiving final FDA approval. Alternatively, Mylan will be permitted to launch an authorized generic version of Actavis' product beginning on October 1, 2015. Pursuant to the agreement, the parties pending litigation will be dismissed. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission.