Pantoprazole is a proton pump inhibitor used to reduce or prevent the production of gastric acid.

Israel-based Teva launched its generic version in December 2007, whilst India-based Sun Pharma launched its generic pantoprazole in the US in February 2008 [1]. Both companies knew they were taking a risk as the patent for Pfizer’s blockbuster acid reflux drug Protonix only expired in January 2011. Prior to the launch of the generics in 2007, Protonix had annual sales of around US$2 billion, but this rapidly decreased following the introduction of generics to the market.

The District Court of New Jersey, USA, ruled that Teva and Sun Pharma had infringed the Protonix patent (No. 4,758,579). The patent is owned by Nycomed, now part of Takeda, and was licensed to Wyeth, now owned by Pfizer.

The settlement, which amounts to US$2.15 billion, comes after an almost 10-year long battle over patent protection of Protonix (pantoprazole). Pfizer will take 64% of the settlement, with Takeda getting the rest.

The settlement requires Teva to pay Pfizer and Takeda US$1.6 billion in damages and Sun Pharma to pay US$550 million. Teva will split the payments over 2013 and 2014, paying US$800 million in 2013 and the remaining US$800 million by October 2014. Sun Pharma will make the entire payment in 2013. As part of the settlement, both Teva and Sun have admitted that their sales of generic pantoprazole infringed the patent that was held valid by the court.

Both companies can continue to sell their generics of pantoprazole in the US.

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Sun and Teva losing battle over generic Protonix [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 14]. Available from: www.gabionline.net/Generics/News/Sun-and-Teva-losing-battle-over-generic-Protonix

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