News from Hepatitis Week of Feb. 9, 2003 / Vol. 3 No. 06

Generic Version of Ribavirin for Hepatitis C Clears One Hurdle

Three Rivers Pharmaceuticals has settled one of its patent lawsuits in its quest to make a generic version of the hepatitis C treatment ribavirin.

The Schering Corporation has provided Three Rivers a non-exclusive license for all of its U.S. patents related to ribavirin. In return for this license, Three Rivers will pay Schering a reasonable royalty based upon net sales of its generic version of the product.

Schering markets ribavirin under the brand name Rebetol, which had sales of about $800 million in the past year.

Three Rivers is currently seeking approval from the U.S. Food and Drug Administration to manufacture and commercially market a generic form of the drug ribavirin.

"We are very pleased with the terms of the settlement. It places Three Rivers one step closer to providing an affordable version of ribavirin to persons afflicted with hepatitis C," said Donald Kerrish, president of Pittsburgh-based Three Rivers.

According to Three Rivers, the generic product won't be launched until its patent lawsuit with Ribapharm, Inc. is resolved and FDA approval is granted. The trial is set to begin in May.

Scott Tarriff, President and CEO of Par Pharmaceutical, which is partnering with Three Rivers on the generic product, said the companies are aggressively pursuing the remaining obstacles. He said it is impossible to predict when the generic product will be launched.

Schering said patent litigation with Geneva Pharmaceuticals and Teva Pharmaceuticals relative to Schering-Plough's U.S. ribavirin patents has been temporarily stayed while the parties seek to reach a settlement.

Geneva and Teva are each seeking FDA seeking approval to market a generic ribavirin product.

Other sources: Three Rivers Pharmaceuticals, Parr Pharmaceuticals, Schering-Plough