Glenmark Pharmaceuticals Inc., the US arm of Glenmark Pharmaceuticals Ltd., has announced the upcoming launch of Sodium Phosphates Injection USP in the United States, with distribution scheduled to begin in April 2026. The injectable product will be available in three single-dose vial strengths: 15 mM P/5 mL, 45 mM P/15 mL, and 150 mM P/50 mL (3 mM P/mL).
The company stated that its Sodium Phosphates Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug, Sodium Phosphates Injection USP, 45 mM P/15 mL (3 mM P/mL), marketed by Hospira, Inc. under NDA 018892. The 15 mM P/5 mL and 150 mM P/50 mL (3 mM P/mL) presentations are also expected to have the same therapeutic effect as the listed drug product relied upon by the US Food and Drug Administration (FDA) as the basis for safety and effectiveness.
Glenmark clarified that the product has been approved only for the indications mentioned in its approved label and is not being marketed for all indications of the reference listed drug.
According to IQVIA National Sales Perspectives data for the 12-month period ending December 2025, the Sodium Phosphates Injection USP market, including the brand and all available therapeutic equivalents, recorded annual sales of approximately $66.8 million in the US. The IQVIA data obtained by Glenmark reflects retail and non-retail sales across approved RLD indications.
Commenting on the development, Marc Kikuchi, President and Business Head, North America, said the upcoming launch reinforces the company’s commitment to bringing quality and affordable alternatives to patients while expanding its portfolio within the institutional channel. The launch is expected to further strengthen Glenmark’s presence in the US injectable and hospital-focused generics segment.