Mylan reaches oxybutynin supply agreement with Ortho-McNeil, Alza

By Angela McDaniels

Seattle, Dec. 20 - Mylan Laboratories Inc. said its subsidiary Mylan Pharmaceuticals Inc. has entered into supply agreements with Ortho-McNeil Pharmaceutical Inc. and Alza Corp. for oxybutynin chloride extended-release tablets, a generic version of Ditropan XL oxybutynin chloride extended-release tablets.

Mylan said it has received tentative approval from the Food and Drug Administration for its 5 and 10 mg strengths of oxybutynin. This follows the Northern District of West Virginia Court's ruling in September that Mylan's oxybutynin extended-release delivery system does not infringe upon Alza's patent. The court further concluded that Alza's patent was invalid, Mylan said.

The exclusive supply agreement on all strengths of oxybutynin chloride will be triggered upon a final appellate court decision in the patent litigation, 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. Mylan will be granted a non-exclusive, royalty-bearing license to make and sell its Abbreviated New Drug Application products.

The terms of the agreements are confidential and subject to a number of conditions, including review by the Federal Trade Commission.

Mylan is a pharmaceutical company based in Pittsburgh that develops, licenses, manufactures, markets and distributes generic and proprietary products.

Ortho-McNeil is a pharmaceutical company based in Raritan, N.J. Alza develops drug-delivery systems and is based in Mountain View, Calif. Both are subsidiaries of Johnson & Johnson.

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