CSL's Venofer
CSL's Venofer finally faces generic competition as FDA clears copycats from Viatris, Sandoz and Amphastar
Venofer generated sales of about $515 million in the U.S. for the 12 months that ended on June 30, 2025, Viatris said, citing IQVIA data. Generic versions of CSL’s iron replacement therapy Venofer have arrived in the U.S. after a yearslong wait.
Monday, Viatris and Amphastar Pharmaceuticals both said they have received the FDA’s approval for their iron sucrose injection products to treat iron deficiency anemia in patients with chronic kidney disease.
In both cases, the companies secured approval for their Venofer generics at three dose strengths—50 mg/2.5mL, 100mg/5mL and 200mg/10mL—in single-dose vials.
In its Aug. 11 press release, Viatris claimed 180-day market exclusivity for the two higher doses and said it will make all three strengths available imminently. For its part, Amphastar CEO Jack Zhang, Ph.D., said in a separate Aug. 11 statement that the company will launch its iron sucrose injection this quarter, without claiming market exclusivity.
A spokesperson for Viatris confirmed to Fierce Pharma that the company has launched all three strengths of the product at an undisclosed discount to Venofer. Amphastar did not immediately reply to a request for clarification on its launch time frame.
To encourage the development of generic drugs, the FDA grants a 180-day market exclusivity—starting on the date of commercialization—to the first generic applicant that meets certain criteria. The period prevents the FDA from approving subsequently submitted generic applications.
Multiple applicants can be considered first applicants, and separate 180-day exclusivity periods are available for each strength of the same drug product, according to an FDA Q&A document published in 2017.
Besides Amphastar and Viatris, Sandoz also appears to have simultaneously received clearance for three dose strengths of iron sucrose, according to FDA records. The Swiss company did not respond to Fierce’s request for comment by publication time.
CSL picked up Venofer as part of its $11.7 billion acquisition of Vifor Pharma in 2021. The drug was approved in the U.S. in 2000 and is being sold by Daiichi Sankyo subsidiary American Regent in the U.S.
Venofer generated sales of about $515 million in the U.S. for the 12 months that ended June 30, 2025, Viatris said, citing IQVIA data.
The possibility of a potential Venofer generic entry has been floating around for years. Viatris had originally projected a launch in 2022 and then listed iron sucrose among six key new product launches expected in North America in 2024.
During a conference call last year, Herve Gisserot, general manager of CSL Vifor, said the company was “extremely well prepared” for potential Venofer generic competition in the U.S.
