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Forest Laboratories, Inc. (FRX) Files Lawsuit Against Several Companies For Infringement Of NAMENDA XR ® Patents


2/3/2014 7:17:47 AM

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Forest Laboratories, Inc. Files Lawsuit Against Several Companies for Infringement of NAMENDA XR® Patents

NEW YORK--(BUSINESS WIRE)-- Forest Laboratories, Inc. (FRX) and Forest Laboratories Holdings, Ltd. (collectively, “Forest”) announced that Forest, Merz Pharma GmbH & Co. KgaA (“Merz”) and Adamas Pharmaceuticals, Inc. (“Adamas”) have jointly filed a lawsuit in the U.S. District Court for the District of Delaware against several companies for infringement of some or all of U.S. Patent Nos. 5,061,703 (“the ’703 patent”); 8,039,009 (“the ’009 patent”); 8,168,209 (“the ’209 patent”); 8,173,708 (“the ’708 patent”); 8,283,379 (“the ’379 patent”); 8,329,752 (“the ’752 patent”); 8,362,085 (“the ’085 patent”); and 8,598,233 (“the ’233 patent”) (collectively, “the Patents”), which relate to Forest’s NAMENDA XR® product. Forest licenses the ‘703 patent, which expires in April 2015, from Merz, and the ’209, ’708, ’379, ’752, ’085 and ’233 patents, which expire in November 2025, from Adamas. Forest owns the ’009 patent, which expires in March 2029.

The defendants named in the lawsuit include Sun Pharma Global FZE, Teva Pharmaceuticals USA, Inc., Wockhardt Bio AG, and related companies and subsidiaries.

Forest received notification from these companies that they had filed Abbreviated New Drug Applications (“ANDAs”) with Paragraph IV certifications seeking approval to market generic versions of NAMENDA XR before the expiration of some or all of the Patents. The aforementioned lawsuit was commenced before the expiration of forty-five days from the date of receipt of each notification letter, which triggered an automatic stay of approval of the applicable ANDAs that expires no earlier than June 2016 (unless the court issues a decision adverse to Forest, Merz, and Adamas earlier).

About Forest Laboratories and Its Products

Forest Laboratories (FRX) is a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market. The Company markets a portfolio of branded drug products and develops new medicines to treat patients suffering from diseases principally in the following therapeutic areas: central nervous system, cardiovascular, gastrointestinal, respiratory, anti-infective, and cystic fibrosis. Our 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.

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.

Contact:
Forest Laboratories, Inc.
Frank J. Murdolo
Vice President - Investor Relations
212-224-6714
Media.relations@frx.com
or
Amanda Kaufman
Senior Manager, Corporate Communications and Media Relations
amanda.kaufman@frx.com

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