The Injectafer patent litigation between Vifor Pharma and American Regent has been settled
Disputes over Injectafer(ferric carboxymaltose) filed under the Abbreviated New Drug Application (ANDA) have been resolved.
Vifor Pharma Group and its partner, American Regent, Inc., a Daiichi Sankyo Group company, announced today that they have reached settlement agreements with Mylan Laboratories Ltd. and Sandoz, Inc., to end patent litigation brought in response to Abbreviated New Drug Applications seeking FDA approval to market a generic version of Injectafer.
Vifor Pharma and American Regent will provide Mylan Laboratories Ltd. and Sandoz, Inc. licences to market generic ferric carboxymaltose products in the United States commencing July 1, 2026, under the terms of the settlements (subject to U.S. FDA approval). All settlements are kept under wraps.
“We are pleased to have settled all outstanding patent litigation regarding Injectafer®, 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,”commented Dr. Oliver P. Kronenberg, Group General Counsel of Vifor Pharma.
“Injectafer is an important treatment option for patients with iron deficiency anemia, 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,”said Gretchen Fritz, Chief Legal Officer of American Regent.
More than 1.7 million people in the United States have been treated for iron deficiency anemia. Injectafer has been evaluated in over 40 clinical trials involving over 8,800 individuals all over the world. Since its original European Union (EU) clearance in 2007, Injectafer has been approved in 83 countries and is the most thoroughly investigated intravenous iron.