Pursuant to the settlement, Mylan will have the right to market desloratadine tablets, 5mg, in the US on July 1, 2012, or earlier in certain circumstances, provided that the FDA approves Mylan’s abbreviated new drug application.
Mylan’s product may be the prescription form or an over-the-counter version, depending on the status of Clarinex at the time. Additional terms of the settlement are confidential, and the agreement is subject to review by the Department of Justice and the Federal Trade Commission.