Two Generic Hepatitis C Drugs Win U.S. Approval

Two drugmakers on Wednesday said they had won U.S. approval to sell their generic forms of ribavirin, a mainstay treatment for hepatitis C sold by Schering-Plough Corp. and Roche Holding AG.

Two drugmakers on Wednesday said they had won U.S. approval to sell their generic forms of ribavirin, a mainstay treatment for hepatitis C sold by Schering-Plough Corp. and Roche Holding AG. Swiss drugmaker Novartis AG and Three Rivers Pharmaceuticals LLC, a privately held generic drug manufacturing company based north of Pittsburgh, said their copycats will be launched immediately. Novartis and Three Rivers, which has given Pharmaceutical Resources Inc. rights to market its product, are the only companies that will be allowed to sell generic ribavirin in the United States for the next 180 days. Approvals of the two generics had been widely expected and their arrival could drive down the cost of treating hepatitis C, a virus believed to infect as many as 4 million Americans which is the biggest cause of liver transplants. All forms of ribavirin are approved for use with interferon, an injectable medicine also sold by both Schering-Plough and Roche that stimulates the immune system to fight the virus. Schering-Plough had a U.S. monopoly on its dual therapy until Roche introduced its rival combination treatment in early 2003. The Roche combination therapy now boasts the dominant market share, in part because its brand of ribavirin costs about 40 percent less than Schering-Plough’s. Neither Novartis nor Three Rivers disclosed what they will charge for their generics, but industry analysts expect them to reflect a significant discount from Roche’s price of up to $800 per month. (Source: Reuters Health, April 2004)