Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. and partner, Banner Pharmacaps Inc. (a wholly-owned subsidiary of Patheon Inc.), have entered into a settlement and license agreement with Eisai Inc. and Valeant Pharmaceuticals Luxembourg S.a.r.l that will resolve patent litigation related to Bexarotene Capsules, 75 mg. Bexarotene is the generic version of TARGRETIN®, which is indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.
Pursuant to the agreement, the pending litigation will be dismissed, and Mylan and Banner will receive a license to begin selling a generic version of the product on July 9, 2015, or earlier under certain circumstances. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
Mylan believes that its partner, Banner, is the first company to have filed a substantially complete abbreviated new drug application (ANDA) containing a Paragraph IV certification with the U.S. Food and Drug Administration (FDA) for Bexarotene Capsules, 75 mg. TARGRETIN®, 75 mg, had U.S. sales of approximately $53.6 million for the 12 months ending Sept. 30, 2013, according to IMS Health.
Currently, Mylan has 178 ANDAs pending FDA approval representing $90.8 billion in annual sales, according to IMS Health. Thirty-nine of these pending ANDAs are potential first-to-file opportunities, representing $23.8 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 300 ANDAs pending FDA approval.