Forest Laboratories, Inc., a US-based pharmaceutical company with a long track record of developing and marketing products that make a positive difference in people’s lives, and Forest Laboratories Holdings, Ltd. (collectively, "Forest") announced 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 US 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 US Patent No. 6,545,040, including any extensions and/or pediatric exclusivities or (b) the date Glenmark receives final US 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 US District Court for the Northern District of Illinois.