Forest Labs (FRX) Enters Settlement Over Generic BYSTOLIC Tabs

January 3, 2013 8:05 AM EST Send to a Friend
Forest Laboratories, Inc. (NYSE: FRX) 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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