Forest Laboratories, Inc. Announces Settlement of BYSTOLIC® Patent Litigation
November 07 2013 - 8:00AM
Business Wire
Forest Laboratories, Inc. (NYSE:FRX) and Forest Laboratories
Holdings, Ltd. (collectively, "Forest") announced today that they
have entered into a settlement agreement with Actavis, Inc. and
related companies and subsidiaries thereof, in patent infringement
litigation brought by Forest in response to Actavis’s abbreviated
new drug application ("ANDA") seeking approval to market generic
versions of Forest's BYSTOLIC® (nebivolol) tablets. This settlement
agreement is with the last of the remaining defendants in this
patent infringement litigation.
Specifically, under the terms of the settlement agreements and
subject to review of the settlement terms by the U.S. Federal Trade
Commission, Forest will provide licenses to each of Actavis, Alkem,
Amerigen, Glenmark, Hetero, Indchemie, and Torrent that will permit
these companies to launch their generic versions of BYSTOLIC® as of
the date that is the later of (a) three calendar months prior to
the expiration of U.S. Patent No. 6,545,040, including any
extensions and/or pediatric exclusivities or (b) the date each
company receives final FDA approval of its ANDA, or earlier in
certain circumstances.
About Forest
Laboratories
Forest Laboratories' (NYSE:FRX) longstanding global partnerships
and track record developing and marketing pharmaceutical products
in the United States have yielded its well-established central
nervous system and cardiovascular franchises and innovations in
anti-infective, respiratory, gastrointestinal and pain management
medicine. Forest’s pipeline, the most robust in its history,
includes product candidates in all stages of development across a
wide range of therapeutic areas. 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. Murdolo, 1-212-224-6714Vice
President - Investor Relationsmedia.relations@frx.com
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