ST. GALLEN, Switzerland & SHIRLEY, N.Y.– Vifor Pharma Group and its partner American Regent, Inc., a Daiichi Sankyo Group company, today announced that they have reached settlement agreements with Mylan Laboratories Ltd., and Sandoz, Inc., that resolve the patent litigation brought in response to Abbreviated New Drug Applications seeking approval by the U.S. Food and Drug Administration to market a generic version of Injectafer®.
Under the terms of the settlements, Vifor Pharma and American Regent will grant Mylan Laboratories Ltd., and Sandoz, Inc., licenses to market generic ferric carboxymaltose products in the United States beginning 1 July 2026 (subject to U.S. FDA approval). Details of all settlements are confidential.
“We are pleased to have settled all outstanding patent litigations regarding Injectafer®,” commented Dr. Oliver P. Kronenberg, Group General Counsel of Vifor Pharma. “With these agreements in place, we can continue to focus on addressing the significant remaining unmet medical need to diagnose and appropriately treat iron deficiency anemia to improve lives of U.S. patients, together with our partner American Regent.”
“Injectafer® is an important treatment option for patients with iron deficiency anemia”, said Gretchen Fritz, Chief Legal Officer of American Regent. “American Regent is proud of the innovation and decades of hard work that made this treatment option possible and available to patients in the U.S. We are pleased to resolve the burdens of litigation, and excited for future results of our ongoing robust clinical program for Injectafer®.”
In the US, more than 1.7 million patients have been treated for iron deficiency anemia. Injectafer® has been studied in more than 40 clinical trials that included over 8,800 patients worldwide. Injectafer® has been approved in 83 countries since initial European Union (EU) approval in 2007 and is the most extensively studied intravenous iron.
