Forest Laboratories, Inc. (NYSE: FRX) and Forest Laboratories Holdings, Ltd. (collectively,"Forest") announced today that they have entered into settlement agreements with Alkem Laboratories, Ltd. ("Alkem"), Indchemie Health Specialties Pvt. Ltd. ("Indchemie"), and Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc. (collectively, "Torrent") in patent infringement litigation brought by Forest in response to abbreviated new drug applications (ANDAs) filed by Alkem, Indchemie and Torrent each seeking approval to market generic versions of Forest's BYSTOLIC® (nebivolol) tablets. These settlement agreements are in addition to the previously announced Bystolic patent infringement settlement agreement with Hetero Labs Ltd.
Specifically, under the terms of the settlement agreements and subject to review of the settlement terms by the U.S. Federal Trade Commission, Forest will provide licenses to each of Alkem, Indchemie and Torrent that will permit these companies to launch their 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 each company receives final FDA approval of its ANDA, or earlier in certain circumstances.
Similar patent infringement litigation brought by Forest against Amerigen Pharmaceuticals Ltd., Glenmark Generics Inc., 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.