Elmwood Park, New Jersey: Glenmark Pharmaceuticals Inc., USA (Glenmark) is pleased to announce the upcoming launch1 of Sodium Phosphates Injection USP, 15 mM P/5 mL, 45 mM P/15 mL and 150 mM P/50 mL (3 mM P/mL) Single-Dose Vials. Glenmark’s Sodium Phosphates Injection USP, 15 mM P/5 mL, 45 mM P/15 mL and 150 mM P/50 mL (3 mM P/mL) Single-Dose Vials is bioequivalent and therapeutically equivalent to the reference listed drug, Sodium Phosphates Injection USP, 45 mM P/15 mL (3 mM P/mL), of Hospira, Inc.
[NDA 018892], with the 15 mM P/5 mL (3 mM P/mL) and 150 mM P/50 mL (3 mM P/mL) presentations expected
to have the same therapeutic effect as that of the listed drug product upon which the FDA relied as the basis of
safety and effectiveness. Glenmark will begin distribution in April 2026. According to IQVIA® sales data for the 12-month period ending December 2025, the Sodium Phosphates Injection USP, 15 mM P/5 mL, 45 mM P/15 mL and 150 mM P/50 mL (3 mM P/mL) Single-Dose Vials market2 achieved annual sales of approximately $66.8 million*.
Marc Kikuchi, President & Business Head, North America said, “We look forward to the upcoming launch of Sodium Phosphates Injection USP, 15 mM P/5 mL, 45 mM P/15 mL and 150 mM P/50 mL (3 mM P/mL) Single-Dose Vials, strengthening our commitment to bring to market quality and affordable alternatives for patients, while also further expanding our portfolio of products within the institutional channel.”
1Glenmark’s Sodium Phosphates Injection USP, 15 mM P/5 mL, 45 mM P/15 mL and 150 mM P/50 mL (3 mM P/mL) Single-Dose Vials is only approved for the indication(s) listed in Glenmark’s approved label.
2Market includes brand and all available therapeutic equivalents. Note: IQVIA® data obtained by Glenmark is only
available for all approved RLD indications. Glenmark’s product is only approved for the indications listed in Glenmark’s approved label and is not marketed for all RLD indications.
