Forest Labs (FRX) Enters Settlement Over BYSTOLIC Tabs
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Forest Laboratories, Inc. (NYSE: FRX) and Forest Laboratories Holdings, Ltd. announced today that they have entered into a settlement agreement with Hetero Labs Ltd. and Hetero USA Inc. in patent infringement litigation brought by Forest in response to Hetero’s ANDA seeking approval to market generic versions of Forest’s BYSTOLIC (nebivolol) tablets.
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 Hetero that will permit it to launch its generic version 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 Hetero receives final FDA approval of its ANDA, or earlier in certain circumstances.
Similar patent infringement litigation brought by Forest against Alkem Laboratories, Ltd., Indchemie Health Specialties Pvt. Ltd., Glenmark Generics Inc., Watson Pharmaceuticals Inc., Torrent Pharmaceuticals Ltd., Amerigen Pharmaceuticals Ltd., and related companies and subsidiaries, remains pending in a multidistrict litigation established in the U.S. District Court for the Northern District of Illinois.
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 Hetero that will permit it to launch its generic version 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 Hetero receives final FDA approval of its ANDA, or earlier in certain circumstances.
Similar patent infringement litigation brought by Forest against Alkem Laboratories, Ltd., Indchemie Health Specialties Pvt. Ltd., Glenmark Generics Inc., Watson Pharmaceuticals Inc., Torrent Pharmaceuticals Ltd., Amerigen Pharmaceuticals Ltd., and related companies and subsidiaries, remains pending in a multidistrict litigation established in the U.S. District Court for the Northern District of Illinois.
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