Forest Laboratories, Inc. 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.
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