Generic drug manufacturers say they have cleared a big legal hurdle in their efforts to introduce a generic version of ribavirin for treatment of hepatitis C.
The U.S. District Court for the Central District of California recently ruled that the ribavirin products of generic drug manufacturers Three Rivers, Geneva and Teva did not infringe on the patients of ICN and Ribapharm.
According to Three Rivers, the decision -- barring an appeal -- appears to resolves the remaining ongoing patent barriers to U.S. Food and Drug Administration (FDA) approval of the generics.
Despite the court victory, Three Rivers, in conjunction with its marketing partner Par Pharmaceutical, said it would not commercially launch a ribavirin drug until receiving FDA approval and a final determination on the 180-day exclusivity period granted to generic filers under the Hatch-Waxman Act of 1984.
"We view this as a tremendous victory, not only for Three Rivers and Par, but also for the hepatitis C community. We are committed to providing affordable ribavirin to persons afflicted with hepatitis C," said Donald Kerrish, president of Three Rivers.
Dr. Kim D. Lamon, Ribapharm's president and CEO, expressed disappointment over the court decision and said his company would appeal.
"We are also considering other alternatives," said Lamon. "We cannot comment or speculate on the outcome of any appeal or when the generics may come to market. However, we note that the generics cannot come to market until they have regulatory approval, and they would be entering the market at risk while court proceedings are
Other sources: Pharmaceutical Resources, Ribapharm Inc.