Global pharmaceutical leader Lupin Limited has announced the launch of Glucagon for Injection USP, 1 mg/vial, packaged in an emergency kit, in the United States market on August 11, 2025. This launch marks a significant milestone in Lupin’s expanding portfolio of complex injectables, enhancing treatment options for severe hypoglycemia among diabetes patients and serving diagnostic needs during radiologic procedures.
Key Highlights and Product Overview:
Glucagon for Injection USP, 1 mg/vial, is bioequivalent to Eli Lilly and Company's Glucagon for Injection, offering a reliable generic alternative for managing severe hypoglycemia in pediatric and adult patients with diabetes mellitus.
The product is also indicated as a diagnostic aid to temporarily inhibit gastrointestinal tract movement during radiologic examinations in adults, broadening its clinical utility.
Lupin’s Glucagon for Injection is packaged in an emergency kit designed for ease of use in urgent clinical situations, targeting rapid correction of hypoglycemic episodes.
Based on IQVIA data as of May 2025, the glucagon injection market in the United States is estimated at around $124 million annually, underscoring substantial demand for this critical therapy.
Manufacturing and Regulatory Achievements:
The injectable product is manufactured at Lupin’s state-of-the-art facility in Nagpur, India, which complies with stringent international quality and regulatory standards, ensuring consistent supply and high-quality manufacturing practices.
The approval and subsequent launch follow Lupin receiving final approval from the United States Food and Drug Administration (USFDA) in July 2025, reflecting the company’s capability to produce complex generics that meet rigorous safety and efficacy criteria.
Strategic Impact and Market Positioning:
The introduction of this generic glucagon injection supports Lupin’s strategic goal of expanding access to essential, complex injectable therapies in the US market, particularly for diabetes management.
Glucagon is a life-saving medication used to treat severe hypoglycemia, making its availability critical for emergency care in diabetes patients who experience dangerously low blood sugar levels.
With this launch, Lupin strengthens its position in the diabetes care segment in the US, complementing its recent approval and launch of Liraglutide Injection Single-Patient-Use Prefilled Pens, another key therapy indicated for glycemic control.
The increasing prevalence of diabetes in the US and globally fuels ongoing demand for accessible and affordable treatments like glucagon, presenting a strong growth opportunity for Lupin.
Company Commitment and Future Outlook:
Dr. Shahin Fesharaki, Chief Scientific Officer at Lupin, expressed satisfaction with the launch, stating that these approvals are a meaningful enhancement to Lupin’s portfolio and reaffirm the company’s commitment to expanding patient access to critical therapies. Lupin continues to invest in research, development, and manufacturing capabilities to bring complex generics to global markets, focusing on therapeutic areas with significant patient need.
This launch also emphasizes Lupin’s role as a trusted pharmaceutical partner globally, with a broad presence in over 100 countries and a diverse product range spanning branded and generic formulations, biotechnology products, and active pharmaceutical ingredients.
Conclusion:
Lupin’s launch of Glucagon for Injection USP, 1 mg/vial, in the United States is a vital addition to the diabetes treatment landscape, offering an effective, high-quality generic alternative for managing severe hypoglycemia and supporting diagnostic procedures. Manufactured at Lupin’s advanced Nagpur facility, this product solidifies Lupin’s footprint in complex injectables and diabetes care, reinforcing its commitment to improving patient outcomes with affordable therapies on a global scale.
Source: Lupin Limited official press releases, US FDA announcements, IQVIA market data
