Glenmark Pharmaceuticals Inc., USA, announced the upcoming launch of its Sodium Phosphates Injection USP in three strengths: 15 mM P/5 mL, 45 mM P/15 mL, and 150 mM P/50 mL. The product is bioequivalent to the reference listed drug from Hospira, Inc. Distribution is scheduled to commence in April 2026. The target market achieved annual sales of approximately $66.8 million in the 12 months ending December 2025.
Upcoming US Product Launch Announced
Glenmark Pharmaceuticals Inc., USA (Glenmark), has confirmed the upcoming launch of its Sodium Phosphates Injection USP in three distinct single-dose vial presentations. The launch is slated for April 2026, marking an expansion of Glenmark’s institutional product portfolio in the United States.
Product Details and Equivalence
The specific presentations being launched are:
- 15 mM P/5 mL (3 mM P/mL)
- 45 mM P/15 mL (3 mM P/mL)
- 150 mM P/50 mL (3 mM P/mL)
Glenmark’s product has been deemed bioequivalent and therapeutically equivalent to the reference listed drug, Sodium Phosphates Injection USP, 45 mM P/15 mL (3 mM P/mL), originally developed by Hospira, Inc. [NDA 018892]. The 15 mM and 150 mM presentations are expected to provide the same therapeutic effect as the listed drug upon which the FDA based its safety and effectiveness approvals.
Market Opportunity
The announcement highlights the significant market potential for this product line. According to IQVIA® sales data covering the 12-month period ending December 2025, the combined market for these Sodium Phosphates Injection USP strengths achieved annual sales of approximately $66.8 million.
Leadership Commentary
Commenting on the development, Marc Kikuchi, President & Business Head, North America, stated that the launch reinforces Glenmark’s commitment to providing quality and affordable alternatives for patients, thereby further expanding its institutional offerings.
Corporate Context
Glenmark Pharmaceuticals Ltd. is positioned as a global, research-led pharmaceutical company focused on transformative therapies. The company maintains a commercial footprint in 80+ countries and was recognized among the Top 100 biopharmaceutical companies globally by pharmaceutical sales for 2024.
Source: BSE
