Mylan, Actavis Settle Litigation on Generic Generess

By Pharma News - DCAT Publisher

April 15, 2014

Mylan Inc. and its partner Famy Care Ltd. have entered into a settlement and license agreement with Warner Chilcott Company, LLC (now part of Actavis), settling the parties' litigation in connection with Mylan's filing of an abbreviated new drug application (ANDA) with the 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 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, outlined Mylan in a press statement.

Mylan believes that its partner, Famy Care Ltd., is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification with FDA for norethindrone and ethinyl estradiol chewable Tablets 0.8 mg/0.025 mg and ferrous fumarate chewable tablets. For the 12 months ending Dec. 31, 2013, Generess Fe Tablets had U.S. sales of approximately $81.83 million, according to IMS Health, and as reported by Mylan.

Actavis remains in litigation with Lupin Ltd in connection with Lupin's pending ANDA for a generic version of Generess®.

Source: Mylan Inc. and Actavis