Teva Pharmaceutical Industries Ltd. has commercially launched Pantoprazole Sodium Delayed Release (DR) Tablets, 20 mg and 40 mg, which are AB-rated to Wyeth's erosive GERD treatment Protonix DR Tablets.
The brand product had annual sales of approximately $2.5 billion in the United States for the twelve months ended September 30, 2007, based on IMS sales data.
As one of the first companies to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for this product, Teva 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. A trial date has not been set. In September 2007, the District Court denied a motion filed by Wyeth and Altana for a preliminary injunction related to Teva's Pantoprazole Tablets. Wyeth and Altana have filed a notice of appeal.
Following the denial of the preliminary injunction, and a thorough review of the Court's opinion, Teva accelerated launch preparations for its product, which had already been granted final approval by the US Food and Drug Administration (FDA) on August 2, 2007.
Teva and Wyeth/Altana have commenced settlement discussions regarding this product and, to facilitate such discussions, have entered into a standstill agreement pursuant to which Teva agreed not to ship additional product for a period of 30 days.
Although the company expects that the majority of Pantoprazole units will be reflected in its 2008 results, it cannot currently assess the impact of this product on its 2008 financial performance.
Based on this launch and on the data available at this time, and in light of its practice of risk-adjusting forecasts for potential launches, the company is increasing its previous guidance for 2007 fully diluted earnings per share to $2.34 to $2.36, up from reaching the higher end of $2.20 to $2.30.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Over 80 per cent of Teva's sales are in North America and Europe.