Ivax Corporation has entered into a settlement of patent litigation with Amarin Corporation plc which will allow Ivax to begin marketing pergolide mesylate, the generic equivalent of Permax, in early September. The litigation related to two U.S. patents licensed to Amarin by Eli Lilly and Company when Amarin acquired the exclusive U.S. license rights to Permax tablets from Elan Corporation.
Under the terms of the settlement, Ivax receives a nonexclusive U.S. sublicense from Amarin and Lilly to the two patents beginning September 2, 2003, in return for payments to Amarin during the first six months of sales of the product following final approval by the FDA. Ivax previously announced that its ANDA for pergolide mesylate tablets in .05mg, .25mg and 1mg strengths received tentative approval from the FDA. This product will be sold through the company's wholly owned subsidiary, Ivax Pharmaceuticals, Inc. Pergolide mesylate is used as adjunctive treatment in connection with Parkinson's disease. Pergolide's active pharmaceutical ingredient is produced at Ivax' facility in the Czech Republic.