Forest Laboratories, Inc. Announces Settlement Agreement with Hetero Labs Ltd. in BYSTOLIC® Patent Litigation
October 26 2012 - 12:45PM
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 Hetero Labs Ltd. and
Hetero USA Inc. (collectively, “Hetero”) in patent infringement
litigation brought by Forest in response to Hetero’s ANDA seeking
approval to market generic versions of Forest’s BYSTOLIC®
(nebivolol) tablets. Specifically, under the terms of the
settlement agreement and subject to review of the settlement terms
by the U.S. Federal Trade Commission, Forest will provide a license
to Hetero that will permit it to launch its generic version 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 Hetero receives final FDA approval of its ANDA, or earlier in
certain circumstances. Similar patent infringement litigation
brought by Forest against Alkem Laboratories, Ltd., Indchemie
Health Specialties Pvt. Ltd., Glenmark Generics Inc., Watson
Pharmaceuticals Inc., Torrent Pharmaceuticals Ltd., Amerigen
Pharmaceuticals Ltd., and related companies and subsidiaries,
remains pending in a multidistrict litigation established in the
U.S. District Court for the Northern District of Illinois.
About Forest
Laboratories
Forest Laboratories, Inc. (NYSE: FRX) is a U.S.-based
pharmaceutical company with a long track record of building
partnerships and developing and marketing products that make a
positive difference in people’s lives. In addition to its
well-established franchises in therapeutic areas of the central
nervous and cardiovascular systems, Forest’s current pipeline
includes product candidates in all stages of development and across
a wide range of therapeutic areas. The Company is headquartered in
New York, NY. To learn more about Forest Laboratories, 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 Report 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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