Forest Laboratories, Inc. (NYSE: FRX) and Forest Laboratories Holdings, Ltd. (collectively, "Forest") announced today that they have entered into a settlement agreement with Amerigen Pharmaceuticals, Inc. and Amerigen Pharmaceuticals, Ltd. (collectively, "Amerigen") 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.
About Forest LaboratoriesForest Laboratories' (NYSE: FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective, respiratory, gastrointestinal and pain management medicine. Forest’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com. Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.
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