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.
About Forest Laboratories
Forest Laboratories, Inc. (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people’s lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest’s current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more about Forest Laboratories, 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 Report 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.