Forest Laboratories, Inc. Files Lawsuit Against Several Companies for Infringement of NAMENDA XR® Patents
January 31 2014 - 4:05PM
Business Wire
Forest Laboratories, Inc. (NYSE: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 (NYSE: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.
Forest Laboratories, Inc.Frank J. MurdoloVice President -
Investor Relations212-224-6714Media.relations@frx.comorAmanda
KaufmanSenior Manager, Corporate Communications and Media
Relationsamanda.kaufman@frx.com
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