Glenmark Pharmaceuticals Inc., USA has announced its plans to commercially launch Leucovorin Calcium For Injection USP, 350mg/vial Single-Dose Vial, with distribution scheduled to begin in December 2025. This announcement marks another significant addition to the company's expanding injectable pharmaceutical portfolio in the United States market, targeting a substantial market opportunity.

Product Launch Details

The upcoming launch represents Glenmark's continued commitment to providing essential pharmaceutical products to the US healthcare system. The company's Leucovorin Calcium for Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug, Leucovorin Calcium for Injection, 350mg/vial, manufactured by Hospira, Inc.

Market Opportunity

According to IQVIA sales data for the 12-month period ending October 2025, the Leucovorin Calcium for Injection, 350mg/vial market achieved annual sales of approximately $16.80 million. This market data includes brand and all available therapeutic equivalents, presenting a significant opportunity for Glenmark's entry into this therapeutic segment.

Strategic Significance

Leucovorin Calcium is a critical medication used in various therapeutic applications, particularly in oncology settings where it serves as a rescue agent for methotrexate toxicity and as part of combination chemotherapy protocols. Marc Kikuchi, President Business Head, North America, commented on the launch: "We are pleased to announce the upcoming launch of Leucovorin Calcium for Injection USP, 350mg/vial Single-Dose Vial, further expanding our portfolio of products within the institutional channel, while also strengthening our commitment to bring to market quality and affordable alternatives for patients."

Market Expansion

This launch announcement reflects Glenmark Pharmaceuticals' ongoing strategy to strengthen its presence in the US injectable pharmaceuticals market. The December 2025 timeline provides the company with adequate preparation time to ensure proper manufacturing, regulatory compliance, and market distribution arrangements are in place for a successful product introduction into this established market segment.

Glenmark Pharmaceuticals has announced a groundbreaking development in the treatment of Chronic Obstructive Pulmonary Disease (COPD). The company has launched the world's first nebulized, fixed-dose triple therapy for COPD patients, marking a significant advancement in respiratory care.

Key Highlights

• Product Names: Nebzmart GFB Smartules and Glenmark Airz FB Smartules
• Composition: Glycopyrronium, Formoterol, and Budesonide
• Significance: World's first nebulized triple therapy for COPD

Innovation in COPD Treatment

The newly introduced therapy combines three proven medications - Glycopyrronium, Formoterol, and Budesonide - into a single, easy-to-use nebulized treatment. This innovative approach aims to:

• Reduce airway obstruction
• Decrease inflammation
• Improve lung function
• Enhance symptom control

Benefits for Patients

This breakthrough treatment offers several advantages for COPD patients:

1. Simplified Medication Regimen: Minimizes the burden of multiple medications
2. Improved Accessibility: Especially beneficial for patients who struggle with Metered Dose Inhalers (MDI) or Dry Powder Inhalers (DPI)
3. Rapid Improvement: Clinical studies in India showed quick enhancement in lung function and better control of breathlessness (dyspnea)

Clinical Study Results

A clinical study conducted in India demonstrated promising outcomes:

Management Perspective

Mr. Alok Malik, President & Business Head of India Formulations at Glenmark Pharmaceuticals, emphasized the company's commitment to innovation in respiratory care. He stated that this launch reinforces Glenmark's position as a front-runner in respiratory innovation and their dedication to providing advanced, affordable, and accessible solutions for patients.

Dr. Monika Tandon, Global Head of Clinical Development at Glenmark Pharmaceuticals, highlighted the significance of this advancement in COPD management. She noted that the strong efficacy and safety demonstrated in the clinical study support this novel treatment approach.

About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals is a research-led, global pharmaceutical company with a presence across Branded, Generics, and OTC segments. The company focuses on therapeutic areas of respiratory, dermatology, and oncology. With operations in over 80 countries and 11 world-class manufacturing facilities across four continents, Glenmark continues to make strides in pharmaceutical innovation and accessibility.

This launch of the world's first nebulized triple therapy for COPD underscores Glenmark's commitment to addressing unmet medical needs and improving patient care in the respiratory health sector.