Chicago-based Meitheal Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval for and launched liraglutide injection (18mg/3mL), a generic equivalent of Novo Nordisk's Victoza, addressing ongoing shortages of the critical type 2 diabetes medication.
The approval comes at a crucial time, as both the FDA and the American Society of Health-System Pharmacists (ASHP) have listed branded Victoza in active shortage since March 24, 2025. Meitheal has launched the product in a three-pack configuration, with additional pack sizes expected later this year.
"We are pleased to be launching and bringing liraglutide injection to market — an important option for patients with type 2 diabetes at a time when there is increased demand and limited availability for these medications," said Tom Shea, Chief Executive Officer of Meitheal. "This generic provides patients with a more accessible GLP-1 treatment option, and we look forward to delivering it to our customers as quickly as possible and ensuring a sustainable, high-quality supply."
Market Impact and Commercial Significance
Liraglutide injection, including both generic and branded products, had U.S. sales of approximately $1 billion as of November 2024, highlighting the significant market demand for this medication. The shortage, which began in July 2023, has created accessibility challenges for patients dependent on this therapy.
The approval marks Meitheal's first commercial injector pen product and its first commercial diabetes medication. This launch increases the company's portfolio of on-market generic injectables to 61 products, representing a strategic expansion into the diabetes care market.
Clinical Profile and Therapeutic Use
Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. The medication is available as an injector pen for subcutaneous administration.
The FDA initially approved liraglutide in 2010 for the treatment of type 2 diabetes, with additional indications following in 2014 for weight loss and in 2020 for pediatric patients with obesity. It is now indicated for patients 10 years and older with type 2 diabetes, improving glycemic control while reducing major cardiovascular events for patients with established cardiovascular disease.
According to a review published in Pharmacy and Therapeutics, liraglutide is a long-acting GLP-1 analogue comprised of 97% amino acid homology. Receptors for GLP-1 medications are found in pancreatic cells, the central and peripheral nervous system, the heart, lungs, and gastrointestinal tract, enabling their use across multiple indications.
The medication works by promoting insulin secretion in response to elevated glucose levels while inhibiting glucagon secretion and delaying gastric emptying, creating a multi-faceted approach to glycemic control.
Safety Considerations
Common adverse reactions associated with liraglutide include nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation. Like most GLP-1 medications, liraglutide carries a boxed warning regarding the risk of thyroid C-cell tumors, including medullary thyroid carcinoma, based on studies in rodents, though human relevance remains undetermined.
Other serious adverse effects include acute pancreatitis, acute gallbladder disease, hypoglycemia, elevated heart rate, renal impairment, hypersensitivity reactions, and suicidal behavior and ideations. The medication is contraindicated for patients with thyroid cancer or those with a family history of the condition.
Company Growth and Future Plans
Following the successful approval and launch of 12 new products in 2024, Meitheal is planning to launch 22 new products in 2025, including liraglutide injection, across its core therapeutic areas of anti-infectives, anesthetics, critical care, fertility, and oncology.
In 2023, Meitheal secured an exclusive commercial license for three insulin biosimilars in the U.S., which are currently in clinical development, further strengthening its position in the diabetes care market.
Founded in 2017 and based in Chicago, Meitheal has rapidly expanded its focus beyond generic injectables to include fertility, biologic, and branded products. The company currently has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA.
The launch of generic liraglutide represents a significant step in addressing the ongoing shortage of GLP-1 receptor agonists, providing healthcare professionals and patients with an alternative treatment option during a period of high demand and limited availability.
