Mylan Pharmaceuticals Inc. has entered into two agreements with Ortho-McNeil Pharmaceutical, Inc. and Alza Corporation relating to oxybutynin chloride extended release tablets, a generic version of Ditropan XL oxybutynin chloride extended release tablets.
Mylan has received tentative approval and is currently awaiting final approval from the US Food and Drug Administration for its 5 and 10 mg strengths of oxybutynin. The exclusive supply agreement on all strengths of oxybutynin will be triggered upon a final appellate court decision in the current patent litigation between the parties the terms of which differ depending upon the final outcome. Ortho-McNeil has also agreed to supply Mylan with a generic version of Ditropan XL sooner than a final appellate court decision if another generic version enters the market, states a Mylan release.
Mylan will be granted a non-exclusive, royalty bearing license to make and sell its ANDA products, the terms of which differ depending upon the final outcome of the pending patent litigation. The terms of the agreements are confidential and subject to a number of conditions, including review by the Federal Trade Commission (FTC).
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories, Inc. that develop, license, manufacture, market and distribute an extensive line of generic and proprietary products.