IDA is a common complication of CKD and is associated with a significantly heightened risk of cardiovascular morbidity and higher mortality rates. Iron Sucrose Injection, USP, the first generic version of Venofer® Injection, is expected to be available imminently in single dose vials in the following strengths: 50 mg/2.5mL, 100mg/5mL and 200mg/10mL.
Viatris Chief R&D Officer Philippe Martin said, "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 complex product was developed in-house, and after a number of years working closely with the FDA we are pleased to accomplish this important milestone."
Viatris' robust complex injectable pipeline includes multiple difficult-to-develop and manufacture assets across several therapeutic areas and patient types. The pipeline also includes ferric carboxymaltose injection – another iron replacement product.
Viatris Chief Commercial Officer Corinne Le Goff said, "The U.S. launch of this first-to-market generic iron sucrose will be an important addition to the treatment landscape for chronic kidney disease patients with iron deficiency, and will help increase sustainable access to this critical therapy. Iron sucrose builds on Viatris' large and diversified global business and will further strengthen our generics portfolio."
The FDA granted Viatris a competitive generic therapy (CGT) designation for iron sucrose 100 mg/5 mL and 200 mg/10 mL strengths. CGT designation allows for expedited review of generic versions of medications with "inadequate generic competition." This regulatory pathway helps to expedite market entry of generic drugs and provides eligibility for 180 days of exclusivity upon commercial marketing of the medicine.
Venofer® had annual sales of approximately $515M in the U.S. as of June 30, 2025, according to IQVIA.
Iron Sucrose Injection, For Intravenous Use
INDICATION AND USAGE
Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Known hypersensitivity to iron sucrose.
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving iron sucrose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop iron sucrose immediately. Monitor patients for signs and symptoms of hypersensitivity during and after iron sucrose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer iron sucrose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Most reactions associated with intravenous iron preparations occur within 30 minutes of the completion of the infusion.
Hypotension: Iron sucrose may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of iron sucrose. Hypotension following administration of iron sucrose may be related to rate of administration and/or total dose delivered.
Iron overload: Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. All adult and pediatric patients receiving iron sucrose require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin, and transferrin saturation). Do not administer iron sucrose to patients with evidence of iron overload. Transferrin saturation (TSAT) values increase rapidly after intravenous administration of iron sucrose; do not perform serum iron measurements for at least 48 hours after intravenous dosing.
DRUG INTERACTIONS
Iron sucrose may reduce the absorption of concomitantly administered oral iron preparations.
USE IN SPECIFIC POPULATIONS
Pregnancy: Risk Summary-Clinical Considerations
Untreated IDA in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.
Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as iron sucrose) which may cause fetal bradycardia, especially during the second and third trimester.
Geriatric Use
Dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
About Viatris:
Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India.
For more information please visit, www.viatris.com
