Lupin announced that it has received approval from the U.S. Food and Drug Administration (USFDA) to market two generic injectable medications for the treatment of diabetes.
The approvals cover abbreviated new drug applications (ANDAs) for Liraglutide Injection in single-patient-use prefilled pens and Glucagon for Injection in vials. Both products will be manufactured at Lupin’s injectable facility in Nagpur, India.
The Liraglutide Injection, 18 mg/3 mL (6 mg/mL) prefilled pen is a generic version of Novo Nordisk’s Victoza®, and is indicated as an adjunct to diet and exercise for improving glycemic control in adults and children aged 10 years and older with type 2 diabetes. According to IQVIA MAT May 2025 data, the product recorded annual U.S. sales of approximately USD 458 million.
The company also received approval for Glucagon for Injection USP, 1 mg/vial, packaged in an emergency kit, which is bioequivalent to Eli Lilly’s Glucagon for Injection. It is indicated for treating severe hypoglycemia in pediatric and adult patients with diabetes. This product saw estimated U.S. sales of USD 124 million in the same period.
“This marks a significant addition to our portfolio and reinforces Lupin’s commitment to broadening access to essential diabetes therapies,” said Shahin Fesharaki, Chief Scientific Officer, Lupin.