#United States #Pittsburgh #kidney disease #Viatris #Iron Sucrose

Viatris Launches First Generic Iron Sucrose Injection in the U.S.

Viatris Inc. (Nasdaq: VTRS), a leading global healthcare company, has officially announced that the U.S. Food and Drug Administration (FDA) has granted approval for Iron Sucrose Injection, USP, marking the introduction of the first generic version of this vital medication in the United States. This approval signifies a significant milestone in Viatris' efforts to enhance access to complex generic medicines for patients in need.

Iron Sucrose Injection is an intravenous treatment for iron deficiency anemia (IDA), particularly common among adult and pediatric patients suffering from chronic kidney disease (CKD). CKD patients often experience IDA, which is associated with severe cardiovascular risks and increased mortality rates. The newly approved injection will be available in single dose vials with strengths of 50 mg/2.5mL, 100 mg/5mL, and 200 mg/10mL, making it an easily accessible treatment option for those affected.

Philippe Martin, Viatris' Chief RD Officer, stated, "The first FDA approval of a generic iron sucrose is an important advancement for patients with CKD and iron deficiency anemia and a testament to Viatris' advanced technical and manufacturing capabilities." This achievement is the result of years of dedicated work alongside the FDA, developing a product that aims to improve patients’ health outcomes through effective iron supplementation.

Moreover, Viatris' Chief Commercial Officer, Corinne Le Goff, emphasized that the U.S. launch of this first-to-market generic iron sucrose will significantly enhance the treatment options available for chronic kidney disease patients with iron deficiency. This initiative is in line with Viatris’ broader mission to provide sustainable access to critical therapies and expand its diversified generics portfolio.

The approval comes with the competitive generic therapy (CGT) designation for the 100 mg/5 mL and 200 mg/10 mL strengths. This designation allows for an expedited review process of medications that currently face inadequate generic competition, facilitating faster market entry for such essential drugs while providing a six-month exclusivity period post-launch. As of June 30, 2025, the original brand Venofer® Injection garnered substantial annual sales nearing $515 million in the U.S., highlighting the significance of this generic option for both healthcare providers and patients alike.

Iron Sucrose Injection is primarily indicated for managing iron deficiency anemia in patients diagnosed with chronic kidney disease (CKD). However, it is crucial to note the associated safety information. Patients should be monitored closely when receiving this drug because hypersensitivity reactions can occur, with some cases being severe and even life-threatening. Common adverse effects may include diarrhea, nausea, dizziness, and hypotension, necessitating careful administration and monitoring during treatment.

For pediatric patients, frequent adverse reactions can manifest as respiratory infections, vomiting, and dizziness, underlining the importance of proper therapeutic management across all age groups. Regular monitoring of hemoglobin, hematocrit, and iron parameters is essential to avoid iron overload.

Looking ahead, Viatris is committed to expanding its robust injectables pipeline, including other complex assets across various therapeutic areas. The success of Iron Sucrose Injection in the U.S. market demonstrates Viatris' dedication to addressing some of the most pressing health challenges, ultimately delivering high-quality therapies to millions of patients globally.

Viatris Inc. holds a unique position in the pharmaceutical industry, merging the realms of generics and brands to effectively cater to healthcare needs worldwide. With operations spanning multiple global centers, including Pittsburgh, Shanghai, and Hyderabad, the company aims to provide meaningful access to healthcare, ensuring that patients, regardless of their circumstances, have access to medications that improve their quality of life.

To learn more about Viatris and its mission to empower healthier lives globally, visit Viatris.