Executive Summary

Impax Labs granted tentative approval for generic loratadine/pseudoephedrine extended-release tablets (Schering-Plough's Claritin-D 12- and 24-Hour) on May 29 and May 24, respectively. Hayward, Calif.-based company believes it was first to file for generic 12-hour formulation. Impax, a defendant in Schering's ongoing loratadine patent litigation, also has a pending ANDA for Claritin Reditabs. In December, Impax entered into an agreement granting Novartis Consumer Health exclusive rights to market an OTC generic version of Claritin to be supplied by Impax, which is in discussions with potential OTC partners for two additional generic loratadine formulations. Novartis' Geneva Pharmaceuticals is believed to be first to file for the loratadine 10 mg tablet dosage form...