Mumbai, Dec. 11 -- The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Leucovorin Calcium for Injection, 350 mg/vial, marketed by Hospira Inc. Glenmark stated that distribution of the product will begin in December 2025.

Citing IQVIA sales data for the 12 months ending October 2025, the company said the U.S. market for Leucovorin Calcium for Injection, 350 mg/vial recorded annual sales of approximately $16.8 million, including the brand product and all available therapeutic equivalents.

Glenmark emphasized that its Leucovorin Calcium for Injection USP, 350 mg/vial is approved only for the indications listed on its FDA-approved label and is not marketed for all RLD indications.

Marc Kikuchi, P...