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news.Teva Pharmaceutical Industries has commercially launched pantoprazole sodium delayed release tablets, 20mg and 40mg, which are generic equivalents to Wyeth's erosive gastroesophageal reflux disease treatment Protonix delayed release tablets.
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As one of the first companies to file an abbreviated new drug application containing a paragraph IV certification for this product, Teva said that it has been awarded a 180-day period of marketing exclusivity.
Teva is currently involved in patent litigation with Wyeth and Altana concerning this product in the US District Court for the District of New Jersey. In September 2007, the District Court denied a motion filed by Wyeth and Altana for a preliminary injunction related to Teva’s pantoprazole tablets. Following the denial of the preliminary injunction, and a thorough review of the court’s opinion, Teva said that it accelerated launch preparations for its product, which had already been granted final approval by the FDA in August 2007.