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Rx or OTC for generic desloratadine

This article was originally published in The Tan Sheet

Executive Summary

Generic pharmaceutical firm Mylan may market desloratadine tablets (5 mg) in the U.S. beginning in July 2012 in direct competition with Schering-Plough's Clarinex allergy medication, according to a patent litigation settlement announced April 8. Pending FDA's approval of Pittsburgh-based Mylan's abbreviated new drug application, the firm can market the tablets as Rx or OTC depending on the status at the time for Clarinex, which is considered a likely switch candidate (1"The Tan Sheet" Feb. 4, 2008, p. 5). Sales of desloratadine tablets (5 mg) reached $284 million in the U.S. during 2008, according to IMS Health

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