Forest Labs (FRX) Enters Settlement Over Generic BYSTOLIC Tabs
Tweet
Share
E-mailGet Alerts FRX Hot Sheet
Join SI Premium – FREE
Forest Laboratories, Inc. (NYSE: FRX) and Forest Laboratories Holdings, Ltd. (collectively, "Forest") announced today 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 U.S. 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 U.S. Patent No. 6,545,040, including any extensions and/or pediatric exclusivities or (b) the date Glenmark receives final 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 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 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 U.S. Patent No. 6,545,040, including any extensions and/or pediatric exclusivities or (b) the date Glenmark receives final 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 U.S. District Court for the Northern District of Illinois.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Mondi Says It Does Not Intend To Make An Offer For DS Smith
- RumbleOn Inc. (RMBL) Appoints Michael Quartieri to its Board
- Lifeward (LFWD) Announces the Appointment of Mike Swinford to its Board of Directors
Create E-mail Alert Related Categories
Corporate News, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
