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June 18, 2014
08:36 EDTFRXForest Labs says NAMENDA, NAMENDA XR granted FDA pediatric exclusivity
Forest Laboratories announced that the U.S Food and Drug Administration has granted pediatric exclusivity for memantine hydrochloride. Based on this decision, an additional six months of U.S. market exclusivity will attach to the patents that are listed in FDAs Orange Book for NAMENDA and NAMENDA XR. As previously disclosed, under the terms of settlement agreements, certain generic companies have licenses that will permit these companies to launch their generic versions of NAMENDA three months before the expiration of U.S. Patent No. 5,061,703, including any extensions and/or pediatric exclusivities, or earlier in certain circumstances. Accordingly, we would expect generic entry sometime in July.
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