Pharm'Up 
Glenmark Pharmaceuticals Inc., USA, has announced the official launch of Leucovorin Calcium for Injection USP (350 mg/vial). This single-dose vial is a generic version of the reference listed drug (RLD), Leucovorin Calcium for Injection from Hospira, Inc.
The launch, scheduled for distribution starting in December 2025, marks another significant step in Glenmark’s strategy to provide high-quality, cost-effective injectable medications for the institutional and hospital segments in the United States.
Therapeutic Importance
Leucovorin Calcium is a vital component in oncology and hematology care. It is primarily used for:
- Rescue Therapy: Reducing the toxicity and counteracting the effects of impaired methotrexate elimination.
- Colorectal Cancer: Combined with 5-fluorouracil to improve survival and response rates in advanced colorectal cancer treatment.
- Megaloblastic Anemia: Treating certain types of anemia when oral folic acid therapy is not feasible.
Market Opportunity and Impact
The launch addresses a steady demand within the U.S. healthcare system. According to IQVIA® data, the market for Leucovorin Calcium for Injection (350 mg/vial) recorded annual sales of approximately USD 16.8 million for the 12-month period ending October 2025.
By introducing a bioequivalent and therapeutically equivalent alternative, Glenmark aims to enhance market competition and ensure a consistent supply of this essential medication for healthcare providers.
Leadership Perspective
The expansion reflects Glenmark’s ongoing commitment to its North American “institutional channel,” which focuses on critical care and hospital-administered drugs.
“We are pleased to announce the upcoming launch of Leucovorin Calcium for Injection USP, further expanding our portfolio of products within the institutional channel. This launch strengthens our commitment to bring to market quality and affordable alternatives for patients.” — Marc Kikuchi, President & Business Head, North America, Glenmark Pharmaceuticals Inc.
About the Formulation
The product will be available in a 350 mg Single-Dose Vial, designed for convenience and safety in clinical settings. As a USP-grade injectable, it adheres to stringent quality standards for purity and potency required by the U.S. Food and Drug Administration (FDA).
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