Amphastar Pharmaceuticals Secures FDA Approval for Iron Sucrose Injection, Sets Sights on Major Sales Momentum

Amphastar Pharmaceuticals has secured FDA approval for its Iron Sucrose Injection, with sales expected to reach $80-100 million, targeting about two-thirds of the Venofer market. Analyst Serge Belanger upgraded Amphastar to a Buy rating, citing attractive valuation and new top-line contributor. The FDA has also approved Viatris' Iron Sucrose Injection.

Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) has received FDA approval for its Iron Sucrose Injection, marking a significant milestone in the company's product pipeline. The injection, previously known as AMP-002, is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD) [1].

The approval comes with a six-month exclusivity period, allowing Amphastar to capitalize on the market opportunity. According to IQVIA data, the reference product Venofer® generated approximately $513 million in U.S. sales for the 12 months ended June 30, 2025 [1]. Analyst Serge Belanger upgraded Amphastar to a Buy rating, estimating that the Iron Sucrose Injection could generate $80-100 million in sales, targeting approximately two-thirds of the Venofer market [2].

The Iron Sucrose Injection will be available in three dosage strengths: 50mg/2.5mL, 100mg/5mL, and 200mg/10mL, all packaged in single-dose vials. The product is expected to launch during the third quarter of 2025 [1].

Amphastar's President and Chief Executive Officer, Dr. Jack Zhang, stated, "We are delighted to announce the FDA approval of our generic iron sucrose injection. This approval, once again, demonstrates our dedication to developing complex generics and leveraging cutting-edge, in-house manufacturing expertise to produce both active pharmaceutical ingredients and finished drug products under the highest regulatory standards in the U.S." [1].

The FDA approval follows strong financial results reported by Amphastar for the second quarter of 2025, with earnings per share reaching 85 cents and revenues of $174.4 million [2]. The company also announced an exclusive license agreement for a new product, further bolstering its pipeline.

In addition to the Iron Sucrose Injection, Amphastar's development pipeline includes three ANDAs and one biosimilar insulin candidate currently under FDA review, with a combined market potential exceeding $2.5 billion. The company is also advancing three biosimilars targeting a market worth over $6 billion, as well as two generic products aimed at markets totaling more than $1 billion [1].

The FDA has also approved Viatris' Iron Sucrose Injection, which could impact Amphastar's market share. However, Needham analysts estimate that the Iron Sucrose Injection could still capture a significant portion of the Venofer market [2].

Amphastar's stock price has seen a 4% increase following the FDA approval, reflecting investor optimism about the company's new product and pipeline [2].

References:
[1] https://www.biospace.com/press-releases/amphastar-announces-fda-approval-for-iron-sucrose-injection-usp
[2] https://investorshub.advfn.com/market-news/article/14485/amphastar-shares-rise-following-fda-approval-of-generic-iron-sucrose-injection