Forest Laboratories and Forest Laboratories Holdings announced that they have agreed on settlement of their pharma partnering agreement with Hetero Labs Lt and Hetero USA .
The settlement was achieved on 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 pharma partnering 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 .
The launch will be 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 the date Hetero receives final FDA approval of its ANDA, or earlier in certain circumstances
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