Glenmark to launch Leucovorin Calcium 350 mg/vial in December 2025
The single-dose vial is bioequivalent to Hospira’s reference product and will enter the US market later this year
Glenmark Pharmaceuticals, USA has announced the upcoming launch of Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial. The company stated that its product is bioequivalent and therapeutically equivalent to the reference listed drug, Leucovorin Calcium for Injection, 350 mg/vial, of Hospira, Inc. under NDA 008107. Distribution is scheduled to begin in December 2025.
According to IQVIA sales data covering the 12-month period ending October 2025, the market for Leucovorin Calcium for Injection, 350 mg/vial achieved annual sales of approximately $16.8 million. The market figure includes the brand product and all available therapeutic equivalents. Glenmark noted that IQVIA data obtained by the company is available only for approved reference listed drug indications, and Glenmark’s product is approved only for the indications listed in its own approved label.
Commenting on the launch, Marc Kikuchi, President and Business Head, North America, said, “We are pleased to announce the upcoming launch of Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial, further expanding our portfolio of products within the institutional channel, while also strengthening our commitment to bring to market quality and affordable alternatives for patients.”
Glenmark added that the product is only approved for the indications listed in its approved label and is not marketed for all reference listed drug indications.