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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 Glenmark Generics Inc., USA, Glenmark Generics Ltd.,
and Glenmark Pharmaceuticals Ltd. (collectively, "Glenmark") in patent
infringement litigation brought by Forest in response to Glenmark'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., and Torrent 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 Glenmark 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 Glenmark receives
final FDA approval of its ANDA, or earlier in certain circumstances. Similar
patent infringement litigation brought by Forest against Amerigen
Pharmaceuticals Ltd. and Watson Pharmaceuticals 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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