Banner Pharmacaps Inc. operates as a gelatin-based drug delivery and specialty pharmaceutical company in the United States. It specializes in the research, development, manufacture, and distribution of soft-gelatin pharmaceutical, over-the-counter, and nutritional consumer products. The company offers gelatin capsules, enteric softgels, solubility enhancing products, gelcaps, chewable liquid-filled softgels, chewable gels, controlled release softgels, and non-animal softgels. It serves consumer healthcare and prescription markets, including pharmaceutical, biotech, and nutritional companies worldwide. The company was incorporated in 1992 and is headquartered in High Point, North Carolina. It...
4100 Mendenhall Oaks Parkway
High Point, NC 27265
Founded in 1992
Mylan Pharmaceuticals Inc. and Banner Pharmacaps Inc. Enter into Settlement and License Agreement with Eisai Inc. and Valeant Pharmaceuticals Luxembourg S.a.r.l
Dec 17 13
Mylan Inc. announced that its subsidiary Mylan Pharmaceuticals Inc. and partner, Banner Pharmacaps 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(R), 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(R), 75 mg, had U.S. sales of approximately $53.6 million for the 12 months ending Sept. 30, 2013. 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.