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Forest Laboratories, Inc.
and Forest Laboratories Holdings, Ltd.
(collectively, "Forest") announced today that they have entered into a
settlement agreement with Amerigen Pharmaceuticals, Inc. and Amerigen
Pharmaceuticals, Ltd. (collectively, "Amerigen") in patent infringement
litigation brought by Forest in response to Amerigen's abbreviated new drug
application (ANDA) seeking approval to market generic versions of Forest's
BYSTOLIC® (nebivolol) tablets. This settlement agreement is in addition to the
previously announced BYSTOLIC® patent infringement settlement agreements with
Hetero Labs Ltd., Alkem Laboratories, Ltd., Indchemie Health Specialties Pvt.
Ltd., Torrent Pharmaceuticals Ltd, and Glenmark Pharmaceuticals Ltd.
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 Amerigen that will permit it to launch its 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 Amerigen receives
final FDA approval of its ANDA, or earlier in certain circumstances.
Similar patent infringement litigation brought by Forest against Actavis,
Inc., and related companies and subsidiaries thereof, remains pending in a
multidistrict litigation established in the U.S. District Court for the
Northern District of Illinois.
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