Teva will not begin marketing the drug, pending a ruling on Wyeth’s injunction request.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has obtained US Food and Drug Administration (FDA) marketing approval for its generic version Protonix, made by Wyeth (NYSE:WYE). Teva also obtained 180 days exclusivity.
Protonix is used as a short term treatment of erosive esophagitis associated with Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis, and for treatment of hypersecretory conditions. IMS sales data states that ethical Protonix had $2.5 billion in sale in the 12 months through June 2007.
In May 2004, Wyeth sued Teva and India’s Sun Pharmaceutical Industries Ltd. (BSE:524715) for patent infringement relating to Protonix. On July 31, 2007, the US District Court for the District of New Jersey held a hearing on Wyeth's motion for a preliminary injunction this matter. Teva has agreed not to launch its products until the earlier of a denial of the preliminary injunction or September 7, 2007.
Published by Globes [online], Israel business news - www.globes.co.il - on August 5, 2007
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