Drug: Protonix (pantoprazole)
Company: Wyeth (Pfizer)
Indication: Erosive esophagitis and other conditions involving excess stomach acid
Scoop: After years of legal wrangling, generic companies now will be able to produce their copies of the popular proton pump inhibitor Protonix. Wyeth--now part of Pfizer--and Nycomed filed suits against a number of generic companies, including Sandoz and Teva, to prevent competition. Even as late as last July, Apotex was seeking approval for its 20- and 40-mg versions of drug by including a Paragraph IV certification on the '579 patent in its ANDA. The same patent was at issue in suits against Teva, Sun and KudCo. The patent was set to expire in July, but will enjoy pediatric exclusivity through January 2011.
Teva launched its version of the drug in 2007, claiming it had 180 days of exclusivity because it was one of the first companies to file and ANDA with a Paragraph IV certification on a patent, but stopped shipping to sit down with Wyeth at the negotiating table.