Viatris Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Iron Sucrose Injection, USP, the first generic version of Venofer Injection. This intravenous iron replacement therapy is used to treat iron deficiency anemia (IDA) in adults and children aged two years and older with chronic kidney disease (CKD).
IDA is a frequent complication of CKD and is linked to increased cardiovascular risks and higher mortality. Viatris’ new generic iron sucrose will be available imminently in single-dose vials of 50 mg/2.5 mL, 100 mg/5 mL, and 200 mg/10 mL.
Philippe Martin, Viatris’ Chief R&D Officer, highlighted the significance of the approval: “This first FDA approval of a generic iron sucrose marks a major advancement for CKD patients with iron deficiency anemia and showcases Viatris’ expertise in developing complex injectable therapies.”
The FDA granted Viatris a Competitive Generic Therapy (CGT) designation for the 100 mg/5 mL and 200 mg/10 mL strengths, enabling expedited review and providing 180 days of market exclusivity upon launch. This designation targets medications with limited generic competition to accelerate affordable alternatives reaching patients.
Corinne Le Goff, Chief Commercial Officer at Viatris, emphasized the impact: “Launching the first generic iron sucrose will enhance treatment access for CKD patients and strengthen our growing generics portfolio.”
Venofer® generated approximately $515 million in U.S. sales as of mid-2025, underscoring the market potential for this generic alternative. Viatris continues to expand its pipeline of complex injectable medicines, including ferric carboxymaltose injection, further broadening treatment options for patients worldwide.