Forest Obtains Six Months U.S. Pediatric Exclusivity for NAMENDA® and NAMENDA XR®
NEW YORK--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE:FRX) announced today that the U.S Food and Drug Administration (FDA) 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 FDA's 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 2015.
About Forest Laboratories
Forest Laboratories (NYSE:FRX) is a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market. Forest markets a portfolio of branded drug products and develops new medicines to treat patients suffering from diseases principally in five therapeutic areas: central nervous system, cardiovascular, gastrointestinal, respiratory, and anti-infective. Forest's strategy of acquiring product rights for development and commercialization through licensing, collaborative partnerships and targeted mergers and acquisitions allows Forest to take advantage of attractive late-stage development and commercial opportunities, thereby managing the risks inherent in drug development. In January 2014, Forest acquired Aptalis Pharmaceuticals for $2.9 billion in cash in order to gain access to its GI and Cystic Fibrosis products, including treatments for Ulcerative Proctitis, Duodenal Ulcers, H. Pylori, Anal Fissures, and Pancreatic Insufficiency. In February 2014, Forest and Actavis plc announced an agreement where Forest would be acquired for about $25 billion in cash and stock. The acquisition of Forest by Actavis is contingent upon regulatory and shareholder approvals.
Forest is headquartered in New York, NY. To learn more, visit www.frx.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.
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