CHICAGO, IL, USA I April 03, 2025 I
Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, today announced it has received U.S. Food and Drug Administration (FDA) approval for and launched liraglutide injection (18mg/3mL), its generic equivalent for Victoza
®2
in the U.S.
Liraglutide injection is a glucagon-like peptide-1 (GLP-1) receptor agonist available as an injector pen and used along with diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. As of March 24, 2025, both the FDA and the American Society of Health-System Pharmacists (ASHP) websites have listed branded Victoza
®
in active shortage. Meitheal has launched liraglutide injection (18mg/3mL) in a three-pack and expects to bring additional pack sizes to market 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.”
Liraglutide injection (18mg/3mL), including generic and branded products, had U.S. sales of approximately $1 billion as of November 2024.
3
FDA approval and launch of liraglutide injection increases Meitheal’s portfolio of on-market generic injectables to 61 products. Liraglutide injection represents Meitheal’s first commercial injector pen product and its first commercial diabetes medication. In 2023, Meitheal secured an exclusive commercial license for three insulin biosimilars in the U.S., which are currently in clinical development.
Following the successful approval and launch of 12 new products in 2024, Meitheal is planning for the launch of 22 new products, including liraglutide injection, in 2025 across its core therapeutic areas of anti-infectives, anesthetics, critical care, fertility, and oncology. Meitheal continuously evaluates new product opportunities and prioritizes those that address gaps in the current marketplace.
ABOUT LIRAGLUTIDE INJECTION
Liraglutide injection is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated 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.
Important Safety Information
What should I tell my health care provider before using Liraglutide?
Before using Liraglutide, tell your health care provider if you:
Tell your health care provider about all the medicines you take
, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.
How should I use Liraglutide?
What are the possible side effects of Liraglutide?
Liraglutidemay cause serious side effects, including:
The most common side effects of Liraglutide may include
nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.
Please click here for the
Package Insert
and here for the
Instructions for Use
.
ABOUT MEITHEAL PHARMACEUTICALS, INC.
Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. FDA-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, 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. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for—working together toward a common goal, for the greater good.
Learn more about who we are and what we do at
www.meithealpharma.com
.
SOURCE:
Meitheal Pharmaceuticals
