NEW YORK (BUSINESS WIRE) — Forest Laboratories, Inc. and Forest Laboratories Holdings, Ltd. announced today that they have entered into a settlement agreement with Amerigen Pharmaceuticals, Inc. and Amerigen Pharmaceuticals, Ltd. 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.