Mylan, a global pharmaceutical company committed to setting new standards in health care, and its partner Famy Care have entered into a settlement and license agreement with Warner Chilcott Company, settling the parties' litigation in connection with Mylan's filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (US 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.
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 the US FDA for Norethindrone and Ethinyl Estradiol chewable tablets 0.8 mg/0.025 mg and Ferrous Fumarate chewable tablets. For the 12 months ending December 31, 2013, Generess Fe Tablets had US sales of approximately $81.83 million, according to IMS Health.
Currently, Mylan has 187 ANDAs pending US FDA approval representing $94.9 billion in annual brand sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $ 25.4 billion in annual brand sales, for the 12 months ending December 31, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 304 ANDAs pending FDA approval.