Seasonal and perennial allergic rhinitis drug is projected to launch mid-2012.
FDA has rubber-stamped Perrigo’s desloratadine (5 mg) tablets, a generic version of Schering-Plough’s Clarinex® tablets, for treating seasonal and perennial allergic rhinitis. Approval of the drug follows the 2008 settlement of a patent infringement lawsuit against Perrigo, relating to its filing of an ANDA containing a Paragraph IV certification.
Under terms of the settlement the firm will be able to commercially launch the generic desloratadine product on July 1, 2012, or potentially earlier under certain circumstances. Whether the drug will be launched as a prescription or OTC product will depend on its status at the time, Perrigo states.
Last month FDA approved Perrigo’s ANDA for guaifenesin extended-release tablets, 600 mg, as a generic version of Mucinex® tablets. Perrigo is still in litigation with Reckitt Benckiser, the NDA holder and patent owner of Mucinex.