FDA Tentatively Approves Eagle Pharma’s Alimta Copycat
The FDA granted tentative approval to Eagle Pharmaceuticals’ version of Eli Lilly’s cancer drug Alimta.
Final approval hinges on the result of a patent battle with Lilly. If Eagle secures that approval, the firm expects to capture between a quarter and a third of the market.
Lilly filed the lawsuit last month, arguing the company infringed on its patents for Alimta, which made Lilly $2.28 billion last year. If the patents are ruled valid, no other company can market a cheaper alternative in the U.S. through May 2022.