Mylan, Banner To Market Generic Targretin

Mylan Pharmaceuticals and Banner Pharmacaps, a wholly-owned subsidiary of Patheon, have entered into a settlement and license agreement with Eisai Inc. and Valeant Pharmaceuticals 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.

Their 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 ANDA containing a Paragraph IV certification with the 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.