Meitheal Pharmaceuticals Announces Approval and Launch of Liraglutide Injection in the United States

• Liraglutide injection is a GLP-1 receptor agonist used to improve glycemic control in adults and pediatric patients with type 2 diabetes
• More than 38 million people live with diabetes in the U.S.¹, with 90-95% of those having type 2
• With continued and elevated demand for the GLP-1 class of medicines, bringing a generic GLP-1 medication to market underscores Meitheal’s commitment to meeting patients’ needs through a sustainable, affordable supply of critical medicines

CHICAGO--(BUSINESS WIRE)--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:

• have or have had problems with your pancreas, kidneys, or liver
• have any other medical conditions or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food
• are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)
• are pregnant or breastfeeding or plan to become pregnant or breastfeed

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?

• Inject under the skin of your stomach (abdomen), thigh, or upper arm. Do not inject Liraglutide into a muscle or vein
• Change (rotate) your injection site within the area you choose with each injection to reduce your risk of getting lumps under the skin (cutaneous amyloidosis). Do not use the same site for each injection
• Do not mix insulin and Liraglutide together in the same injection
• You may give an injection of Liraglutide and insulin in the same body area (such as your stomach area), but not right next to each other
• Do not share your Liraglutide pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them

What are the possible side effects of Liraglutide?

Liraglutide may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis). Stop using Liraglutide and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
• low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Liraglutide with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. In children who are 10 years of age and older, the risk for low blood sugar may be higher with Liraglutide regardless of use with another medicine that can also lower blood sugar. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery
• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse
• serious allergic reactions. Stop using Liraglutide and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or a very rapid heartbeat
• gallbladder problems. Gallbladder problems have happened in some people who take Liraglutide. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in the upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools
• food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Liraglutide may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Liraglutide before you are scheduled to have surgery or other procedures

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.

MEDIA CONTACT
Meitheal Pharmaceuticals, Inc.
John Spilman, VP of Corporate Strategy
773 899 5910
info@meithealpharma.com