Bloomberg News

Savient Sues Sandoz, Upsher-Smith Over Oxandrin

December 04, 2006

Savient Pharmaceuticals Inc. sued Novartis AG (NOVN)'s Sandoz Pharmaceuticals unit and Upsher-Smith Laboratories Inc. to prevent them from selling generic versions of Oxandrin, a weight-gain drug.

Savient, based in East Brunswick, New Jersey, claimed the companies infringed five patents on ways to use oxandrolone, the key ingredient in Oxandrin. The medicine is prescribed for patients who lose weight because of surgery, infection, AIDS or severe injury. The suit was filed today in federal court in New Jersey.

The drug is Savient's only product in the U.S., accounting for all its $15.9 million in sales in the third quarter. Savient said it believes the companies have received regulatory approval for generic versions of the drug and will seek an emergency order from the court to prevent them from entering the market until the suit is resolved.

To keep part of the sales if generic versions of Oxandrin reach the market, Savient signed an agreement with Watson Pharmaceuticals Inc. (WPI:US) for a so-called authorized generic. Savient will supply the drug to Corona, California-based Watson to sell without the brand name, and the companies will split the proceeds.

Savient also sued Barr Laboratories Inc. over its plan to sell a generic version of the drug. That lawsuit also is pending in New Jersey. Savient said it filed the suit against Sandoz and Upsher-Smith after learning that the U.S. Food and Drug Administration had rejected the company's petitions to require additional studies before any generic drug could be approved.

Sandoz is the generic-drug unit of Basel, Switzerland-based Novartis. It is the world's second-biggest generic-drug company behind Teva Pharmaceutical Industries Ltd. (TEVA) Closely held Upsher- Smith Laboratories is based in Maple Grove, Minnesota. Officials with the two companies didn't immediately return messages seeking comment.

Shares of Savient fell 30 cents to $11.63 in Nasdaq Stock Market trading at 4 p.m. New York time. The shares have more than tripled this year. Novartis American depositary receipts, each representing one ordinary share, fell 24 cents to $57.59 in New York Stock Exchange composite trading.

The case is Savient Pharmaceuticals Inc. (SVNT:US) v. Sandoz Inc., 06cv5782, U.S. District Court for the District of New Jersey.

To contact the reporters on this story: Bob Van Voris in New York at; Susan Decker in Washington at

To contact the editor responsible for this story: Patrick Oster at

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