Forest Laboratories Inc. has been granted pediatric exclusivity for its Namenda and Namenda XR Alzheimer's medications from the Food and Drug Administration.


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Forest gains U.S. pediatric exclusivity for Namenda

June 18th, 2014

NEW YORK – Forest Laboratories Inc. has been granted pediatric exclusivity for its Namenda and Namenda XR Alzheimer's medications from the Food and Drug Administration.

Forest said Wednesday that based on the FDA decision, an additional six months of U.S. market exclusivity will attach to the patents that are listed in the agency's Orange Book for Namenda and Namenda XR.

The company added that under settlement agreements, certain generic companies have licenses that will permit them to launch their generic versions of Namenda three months before the expiration of its, including any extensions and/or pediatric exclusivities, or earlier in certain circumstances.

Forest said it would expect a generic market entry for the drug in July 2015.

The drug maker shipped Namenda XR (memantine hydrochloride, 28 mg) — a higher-dose, once-daily extended-release formulation of its Namenda (memantine) immediate-release medication — last week. 

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