Glenmark Pharmaceuticals Inc., USA has announced that it is gearing up to launch Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial in the United States. The product has been deemed bioequivalent and therapeutically equivalent to Hospira Inc.’s reference listed drug, Leucovorin Calcium for Injection, 350 mg/vial (NDA 008107). Glenmark confirmed that commercial distribution will begin in December 2025, marking another addition to its expanding institutional portfolio.
This launch comes at a time when demand for cost-effective injectable therapies continues to grow across the U.S. healthcare system. According to IQVIA sales data for the 12-month period ending October 2025, the overall market for Leucovorin Calcium for Injection, 350 mg/vial recorded sales of around USD 16.8 million. Glenmark aims to strengthen its presence in this therapeutic space by offering a reliable, high-quality generic alternative.
Marc Kikuchi, President and Business Head for North America at Glenmark, said the company is pleased to bring this product to market, emphasising that it reinforces Glenmark’s commitment to delivering affordable treatment options for patients and healthcare providers. He noted that the introduction of Leucovorin Calcium for Injection USP supports the company’s strategy of expanding its institutional product lineup.
Glenmark’s version of the product is approved only for the specific indications mentioned in its FDA-approved label. While the broader market figures from IQVIA include both the branded version and all therapeutic equivalents, Glenmark clarified that its product is marketed strictly within the scope of its own approved indications.
The upcoming launch highlights Glenmark’s ongoing focus on strengthening its U.S. generics business with products that address critical needs in hospitals and clinical settings. As distribution begins in December, the company is positioned to further enhance its footing in the injectable oncology-supportive care category and the wider institutional segment.
