Glenmark Pharmaceuticals Inc., USA will launch Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial in December 2025. The product is bioequivalent and therapeutically equivalent to Hospira, Inc.’s reference listed drug. The Leucovorin Calcium for Injection, 350 mg/vial market achieved annual sales of approximately $16.8 million, according to IQVIA® data.
Leucovorin Calcium Injection Launch
Glenmark Pharmaceuticals Inc., USA (Glenmark) is set to launch Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial in the US market. The launch is scheduled for December 2025.
Product Equivalence
Glenmark’s Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug, Leucovorin Calcium for Injection, 350 mg/vial, of Hospira, Inc. [NDA 008107].
Market Opportunity
According to IQVIA® sales data for the 12-month period ending October 2025, the Leucovorin Calcium for Injection, 350 mg/vial market achieved annual sales of approximately $16.8 million.
Executive Commentary
Marc Kikuchi, President & Business Head, North America, stated, “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.”
Additional Information
Glenmark Pharmaceuticals Ltd. is a research-led, global pharmaceutical company with a presence across Branded, Generics, and OTC segments, focusing on therapeutic areas of respiratory, dermatology, and oncology. The company has 11 world-class manufacturing facilities across 4 continents and operations in over 80 countries.
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