Caraco granted summary judgment for generic Ultracet

By Angela McDaniels

Seattle, Oct. 24 - Caraco Pharmaceutical Laboratories Ltd. said the U.S. District

Court for the Eastern District of Michigan granted Caraco's motion for non-infringement on its generic version of Ultracet.

Caraco said it filed an Abbreviated New Drug Application which sought approval to market its generic version of Ortho-McNeil Pharmaceutical Inc.'s Ultracet drug product and contained a Paragraph IV certification challenging the Ortho-McNeil patent.

On Sept. 22, 2004, Ortho-McNeil filed a complaint alleging that Caraco's filing of the application infringed upon Ortho-McNeil's patent, which expires in 2011, Caraco said. Ortho-McNeil then sought an order from the court which directed the FDA not to approve Caraco's application any earlier than the expiration date.

On Oct. 19, Caraco's motion for summary judgment was granted. Caraco noted that Ortho-McNeil has the right to appeal.

"We are currently awaiting final FDA approval of Tramadol with acetaminophen, our generic version of Ultracet, in order to market this product," said Daniel H. Movens, chief executive officer.

Detroit-based Caraco develops generic and private-label prescription pharmaceuticals for wholesalers, distributors, drugstore chains and managed care providers.

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