Viatris Stock Rises 3% After FDA Approval for Generic Iron Sucrose Injection

Viatris' (VTRS) stock rose 3% after receiving FDA approval for its Iron Sucrose Injection, the first generic version of Venofer Injection. The product, used to treat iron deficiency anemia in adult and pediatric patients with chronic kidney disease, has annual US sales of approximately $515 million. The FDA also granted Viatris Competitive Generic Therapy designation, providing 180 days of market exclusivity.

Viatris Inc. (NASDAQ: VTRS) saw its stock climb by 3% following the U.S. Food and Drug Administration (FDA) approval of its Iron Sucrose Injection, USP. This approval marks the first generic alternative to Venofer® Injection, an intravenous iron replacement therapy prescribed for iron deficiency anemia in both adult and pediatric patients suffering from chronic kidney disease (CKD).

The FDA granted Viatris a competitive generic therapy (CGT) designation for the 100 mg/5 mL and 200 mg/10 mL formulations of Iron Sucrose Injection. This designation accelerates the review process and provides 180 days of market exclusivity upon commercial launch. The product will be available in single-dose vials across three dosage options: 50 mg/2.5mL, 100 mg/5mL, and 200 mg/10mL.

Viatris Chief R&D Officer Philippe Martin highlighted the significance of this approval, stating, "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." The company also noted its robust pipeline of complex injectable products across various therapeutic areas, including ferric carboxymaltose injection, another iron replacement therapy.

According to IQVIA data, Venofer® recorded approximately $515 million in U.S. sales for the 12 months ending June 30, 2025 [1].

Viatris Chief Commercial Officer Corinne Le Goff emphasized the importance of this launch, "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."

References:
[1] https://investorshub.advfn.com/market-news/article/14489/viatris-shares-climb-following-fda-clearance-of-first-generic-iron-sucrose-injection
[2] https://www.marketscreener.com/news/viatris-announces-approval-of-first-generic-iron-sucrose-injection-in-the-u-s-ce7c5ed2d188f026