FDAnews Drug Daily Bulletin

Cypress Pharmaceutical and GlaxoSmithKline (GSK) have resolved patent litigation related to Cypress’ abbreviated new drug application (ANDA) for generic Zantac syrup. The company expects to launch the stomach ulcer drug immediately upon receiving FDA approval.

Under the terms of the settlement, GSK has agreed not to assert its patent against Cypress’ new alcohol-free formulation of its generic Zantac (ranitidine HCl) syrup, Cypress said.

GSK sued Cypress in June 2007 after the company filed an ANDA for generic Zantac syrup with a Paragraph IV certification claiming that the ’249 patent would not be infringed on by the proposed generic product. GSK asked the U.S. District Court for the Southern District of New York to rule that the FDA may not approve Cypress’ generic product until after GSK’s patent and pediatric exclusivity expire in May 2009.