US drugmaker Forest Laboratories (NYSE: FRX) has entered into a settlement agreement with generics drug major Actavis (NYSE: ACT) and related companies and subsidiaries, in patent infringement litigation relating to its antihypertensive drug Bystolic (nebivolol).
Forest brought the legal action in response to Actavis’ Abbreviated New Drug Application seeking approval to market generic versions of Bystolic. This settlement agreement is with the last of the remaining defendants in this patent infringement litigation.
Specifically, under the terms of the settlement agreements and subject to review of the settlement terms by the US Federal Trade Commission, Forest will provide licenses to each of Actavis, Alkem, Amerigen, Glenmark, Hetero, 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 US Patent No. 6,545,040, including any extensions and/or pediatric exclusivities or (b) the date each company receives final Food and Drug Administration approval of its ANDA, or earlier in certain circumstances.
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