Cephalon Inc. said U.S. antitrust regulators demanded information and documents on the company's 2005-2006 agreements with generic drugmakers related to the sleep-disorder drug Provigil, the company's biggest product.
The Federal Trade Commission could challenge the accords only through administrative or judicial proceedings in the event the agency believes the terms violate U.S. antitrust laws, said Cephalon, based in Frazer, Pa., in a regulatory filing Friday. Such action would take years and probably wouldn't have a material adverse impact, the company said.
The subpoena marks the second time the commission has requested additional information on patent settlements that postpone sales of low-cost versions of Provigil until 2012. Cephalon is trying to hold on to sales of the drug, which rose 42 percent to $727.9 million for 2006, while developing a new version called Nuvigil.
The commission initially requested information a year ago and asked for additional documents in July. Cephalon reached Provigil settlements with Barr Pharmaceuticals Inc., Mylan Laboratories Inc., Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd.
Jon Leibowitz, a commissioner of the FTC, said in an April 24 speech that the four companies sold some patent rights to Cephalon for a combined $136 million.
Contributing: Susan Decker
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