Teva Pharmaceutical Industries Ltd. announced that the US Food and Drug Administration has granted final approval for the company's Abbreviated New Drug Application (ANDA) to market its generic version of Wyeth's Protonix (Pantoprazole Sodium) Delayed Release (DR) tablets, 20 mg and 40 mg.
Teva's Pantoprazole Sodium DR tablets are the AB-rated equivalent of Protonix DR tablets, a product indicated for short term treatment of erosive esophagitis associated with GERD, maintenance of healing of erosive esophagitis and for treatment of hypersecretory conditions. The brand product had annual sales of approximately $2.5 billion for the twelve months ended June 30, 2007, based on IMS sales data.
As one of the first companies to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity, a Teva press release stated.
A patent infringement suit was brought against Teva in May 2004 involving Teva's paragraph IV certification to US Patent No. 4,758,579 related to Teva's Pantoprazole Sodium products. On July 31, 2007, a hearing was held in the US District Court for the District of New Jersey regarding Wyeth's motion for a preliminary injunction in that action. Teva has agreed not to launch its products until the earlier of a denial of the preliminary injunction or September 7, 2007.
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, as well as animal health pharmaceutical products.