Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has reached settlements with Sandoz, Actavis plc (NYSE: ACT), India's Lupin Ltd. (BSE: 500257), and Apotex Corporation on Nuvigil, Teva’s wakefulness product. These settlements dismiss a pending appeal with the US Court of Appeals for the Federal Circuit of a trial court decision that found the patent to be valid and infringed.
Under the settlements, Teva has granted licenses to allow the companies to market their generic products 180 days after Mylan Inc. (NYSE: MYL), the first generic company to file an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for three dosages of Nuvigil. The settlements allow Actavis to launch generic two dosages in June 2016, and the other company may launch these dosages 180 days afterwards. Additional terms of the settlements are agreed by the parties are confidential.
Teva previously settled its Nuvigil patent infringement litigation gainst Mylan, allowin Mylan to begin selling generic versions the drug in June 2016, or earlier under certain circumstances.
Nuvigil had $320 million in sales in 2013 and $101 million in the first quarter of 2014.
Published by Globes [online], Israel business news - www.globes-online.com - on June 17, 2014
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