Glenmark USA Unit Launches Sodium Phosphates Injection USP in Three Forms
Glenmark Pharmaceuticals Inc., USA has announced the upcoming launch of Sodium Phosphates Injection USP in three distinct vial presentations scheduled for April 2026. The product is bioequivalent to Hospira's reference drug and targets a $66.8 million market opportunity according to IQVIA data.
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Glenmark Pharmaceuticals Inc., USA has announced the upcoming launch of Sodium Phosphates Injection USP in three distinct vial presentations, marking a significant expansion in the company's injectable pharmaceutical portfolio. The launch is scheduled to commence in April 2026, with the product being bioequivalent and therapeutically equivalent to the reference listed drug.
Product Specifications and Regulatory Approval
The pharmaceutical company will introduce Sodium Phosphates Injection USP in three specific formulations: 15 mM P/5 mL, 45 mM P/15 mL, and 150 mM P/50 mL (3 mM P/mL) Single-Dose Vials. The product has received regulatory approval as 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].
| Parameter: | Details |
|---|---|
| Product: | Sodium Phosphates Injection USP |
| Vial Forms: | 15 mM P/5 mL, 45 mM P/15 mL, 150 mM P/50 mL |
| Concentration: | 3 mM P/mL |
| Launch Date: | April 2026 |
| Reference Drug: | Hospira, Inc. [NDA 018892] |
| Market Size: | $66.8 million |
Market Opportunity and Sales Data
According to IQVIA sales data for the 12-month period ending December 2025, the Sodium Phosphates Injection USP market achieved annual sales of approximately $66.8 million. This market valuation represents a substantial commercial opportunity for Glenmark's entry into this therapeutic segment, with the company positioned to capture market share through its bioequivalent formulation.
Strategic Leadership Commentary
Marc Kikuchi, President & Business Head, North America, commented on the launch, stating the company looks forward to strengthening its commitment to bring quality and affordable alternatives for patients while further expanding the portfolio of products within the institutional channel. The launch aligns with Glenmark's broader strategy to enhance its presence in the injectable pharmaceuticals segment.
Regulatory and Therapeutic Equivalence
The 15 mM P/5 mL and 150 mM P/50 mL presentations are expected to have the same therapeutic effect as the listed drug product upon which the FDA relied as the basis of safety and effectiveness. Glenmark's product is approved specifically for the indications listed in the company's approved label and maintains compliance with regulatory standards for bioequivalence and therapeutic equivalence.
Historical Stock Returns for Glenmark Pharmaceuticals
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +1.26% | +6.66% | +9.32% | +10.27% | +63.78% | +361.39% |
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