Sun Pharmaceutical Industries Ltd has launched generic pantoprazole sodium Delayed Release (DR) tablets, 40 mg, which is AB-rated to Wyeth's Protonix DR tablets. Sun's product is being sold in the United States by its marketing partner Caraco Pharmaceutical Laboratories.
Sun Pharma had received a US FDA approval for these tablets in September 2007. This strength of pantoprazole sodium has annual sales of approximately US $2.3 billion in the US.
Sun's launch was initiated after the December 22, 2007 commercial launch by Teva Pharmaceutical Industries Ltd of generic pantoprazole sodium tablet products, and after the January 29, 2008 commercial launch by Wyeth of generic pantoprazole sodium tablets product through its designated distributor.
Sun shares a 180-day period or marketing exclusivity with Teva for this product. Sun is currently involved in patent litigation with Wyeth and Altana (now Nycomed) concerning this product in the US district court for the district of New Jersey. Although no trial date has yet been set, in September 2007, the district court denied a motion filed by Wyeth and Altana for a preliminary injunction related to the Sun's pantoprazole tablets. Wyeth and Altana have appealed the district courts decision.