Glenmark Pharmaceuticals to Launch Leucovorin Calcium Injection in USA

Filed: December 11, 2025

Filing Summary

Glenmark Pharmaceuticals Inc., USA, a subsidiary of Glenmark Pharmaceuticals Ltd, 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 drug. According to IQVIA® sales data, the market for this drug achieved annual sales of approximately $16.8 million for the 12-month period ending October 2025. Glenmark’s product is approved for specific indications listed in its label. The company focuses on expanding its product portfolio within the institutional channel.

Glenmark Pharmaceuticals Inc., USA, a subsidiary of Glenmark Pharmaceuticals Ltd, will launch Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial in December 2025. This product is bioequivalent and therapeutically equivalent to the reference listed drug by Hospira, Inc., under NDA 008107.

According to IQVIA® sales data, the market for Leucovorin Calcium for Injection, 350 mg/vial, achieved annual sales of approximately $16.8 million for the 12-month period ending October 2025. Glenmark’s product is approved for the indications listed in its approved label and is not marketed for all reference listed drug indications.

Glenmark Pharmaceuticals Ltd is a research-led, global pharmaceutical company with a presence in branded, generics, and OTC segments. The company focuses on therapeutic areas such as respiratory, dermatology, and oncology. It operates 11 manufacturing facilities across four continents and has operations in over 80 countries.

Glenmark’s strategic priorities include expanding its product portfolio within the institutional channel and providing quality and affordable alternatives for patients. The company has been recognized among the top 100 companies ranked by R&D and pharmaceutical sales in 2022. Additionally, Glenmark’s Green House Gas emission reduction targets have been approved by the Science Based Target initiative in 2023.

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