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Generic Ultracet Gets Tentative FDA OK

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SPRING VALLEY, N.Y. (AP) – Par Pharmaceutical Cos. said Thursday that the Food and Drug Administration granted tentative approval for the company's abbreviated new drug application for tramadol hydrochloride and acetaminophen tablets, the generic form of Ortho-McNeil's Ultracet product for short-term acute pain management.

Par Pharmaceuticals said Ultracet has annual U.S. sales of about $300 million. Par's newly acquired Kali Laboratories unit filed an ANDA with the FDA in August 2002 seeking marketing clearance for its generic version of Ultracet. Par said Kali was the first to file and is entitled up to 180 days of marketing exclusivity for the product. Kali is currently involved in litigation with Ortho-McNeil, who has alleged that Kali's product infringes on the company's patent. Kali has asserted that its product does not infringe this patent and that the patent is invalid and unenforceable. In May, Kali served summary judgment motions in these proceedings.

A tentative approval reflects the FDA's determination that a generic product satisfies approval requirements, subject to the expiration of any patents or exclusivity periods accorded to the brand-name drug. A tentative approval does not allow Par to market the generic product and postpones final approval until all patent/exclusivity issues have expired. Shares of Par were up nearly 1 percent, or 27 cents, at $36.55 in morning trading on the New York Stock Exchange. Source: Associated Press

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