Forest Laboratories Pursues Additional Market Exclusivity to Extend Namenda Patent
Monday, January 13, 2014 8:30 am EST
Public Company Information:
NEW YORK--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE:FRX) announced today that it has submitted to the Food and Drug Administration (FDA) data from its pediatric program to extend the Namenda (memantine HCI) U.S. patent 5,061,703.
If the FDA finds that the submission meets the requirements of the Pediatric Written Request, the company would be entitled to a six-month extension of marketing exclusivity for Namenda after the expiration of the patent on April 11, 2015 to October 11, 2015. We anticipate receiving feedback from the FDA in the 3rd quarter calendar year 2014.
About Forest Laboratories and Its Products
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 us to take advantage of attractive late-stage development and commercial opportunities, thereby managing the risks inherent in drug development. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.
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.