Glenmark Pharmaceuticals Inc., USA, a subsidiary of Glenmark Pharmaceuticals Ltd., has announced the upcoming launch of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) Single-Dose Vial. The company plans to begin distribution in November 2025.
Glenmark’s new product is bioequivalent and therapeutically equivalent to Abbott Laboratories’ reference listed drug (RLD), 8.4% Sodium Bicarbonate Injection, 50 mEq/50 mL (1 mEq/mL), approved under NDA 019443. This equivalence means that Glenmark’s version will deliver the same clinical benefits and efficacy as the original brand.
According to IQVIA® sales data for the 12-month period ending August 2025, the total market for this product—including the brand and other therapeutic equivalents—achieved annual sales of approximately $63.8 million in the U.S.
The product is approved only for the indications listed in Glenmark’s official label, as per U.S. FDA regulations. The launch further strengthens Glenmark’s injectable product portfolio in the United States, reinforcing its commitment to expanding access to affordable, high-quality generic medicines.
