Generic competition to Prozac in USA set for August after appeal court

Generic drug manufacturer Barr Laboratories has said that the US Courtof Appeals has upheld its right to market a generic version of Eli Lilly's antidepressant Prozac (fluoxetine) in the USA, affirming the verdict of an earlier court case last year which reduced the drug's US protection from 2003 to later this year (Marketletter August 21, 2000).

Barr said it now plans to launch its fluoxetine 20mg product on August 2, after Lilly's period of exclusivity for conducting pediatric studies on Prozac expires, and expects to have 180 days' marketing exclusivity as the first company to file for approval of a generic version of the drug. Lilly's Prozac sales were $622 million in the first quarter of 2001, a rise of 2% over the prior year's quarter but with US sales growth propping up the product, which already faces generic competition in countries outside the USA. Analysts have suggested that once several generics players launch competing drugs in the USA, Lilly will lose as much as 80% of its total Prozac revenues.

Lilly said in a statement that it will dispute the finding. "We disagree with the appellate court's revised ruling as strongly as we disagreed with the original decision of the court," commented Rebecca Kendall, Lilly's general counsel. She added that the company is looking into its legal options to continue to fight the case, including a possible review by the Supreme Court.