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FDA approves first generic once-daily GLP-1 medication

Liraglutide, the generic of Victoza, is now available to treat Type 2 diabetes, alongside diet and exercise
Jennifer Larson writer headshot
By | Jan. 2, 2025 Medically reviewed by Karen Berger, Pharm.D.
victoza generic - FDA approval

Key takeaways

  • The FDA recently approved the first generic of Victoza (liraglutide injection) to improve glycemic control in patients 10 years and older with Type 2 diabetes, alongside diet and exercise.

  • Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that helps people with Type 2 diabetes manage their blood sugar levels while also curbing their appetite.

  • The generic version of Victoza follows the approval of a generic version of Byetta (another GLP-1 receptor agonist) in November.

In this article:

As glucagon-like peptide-1 (GLP-1) receptor agonists continue to surge in popularity, the U.S. Food and Drug Administration approved the second generic in this class of medications: liraglutide (Victoza). This approval follows the generic version of Byetta (another GLP-1) in November. Generic liraglutide is the first once-daily generic GLP-1 injectable approved to treat Type 2 diabetes in patients 10 and older, alongside diet and exercise. It’s another treatment option when Victoza, the brand name of liraglutide, is in short supply and GLP-1s, in general, are in great demand.

“The FDA supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance as part of our ongoing efforts to increase access to needed medications,” Iilun Murphy, MD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Generic drugs provide additional treatment options which are generally more affordable for patients. Today’s approval underscores the FDA’s continued commitment to advancing patient access to safe, effective, and high-quality generic drug products.”

How generic Victoza works

At least 90% of the 38 million people in the U.S. with diabetes have Type 2 diabetes, with many of them needing to use medication to help them manage their blood sugar levels. 

Liraglutide works to lower blood sugar in several ways. First, it stimulates the pancreas to release more insulin when blood sugar levels are high, helping prevent the liver from producing too much sugar. This medication also slows down the process of food leaving the stomach, helping control blood sugar levels. 

Victoza is designed to be used with diet and exercise. As a side effect of the medication, many people find that they lose weight, as it helps to curb appetite. 

RELATED: Victoza weight loss

Liraglutide side effects

As with the name-brand version of the product, the potential side effects of this generic version of liraglutide include:

  • Nausea
  • Diarrhea
  • Vomiting
  • Decreased appetite
  • Indigestion (dyspepsia)
  • Constipation

It can cause potentially serious complications, which may include

  • Pancreatitis (inflammation of the pancreas)
  • Kidney impairment or kidney failure
  • Hypoglycemia when used in conjunction with certain other medications, including insulin
  • Acute gallbladder disease

The FDA also cautions that people with a personal or family history of medullary thyroid cancer (MTC) or people with multiple endocrine neoplasia syndrome Type 2 (MEN 2) should not take medications containing liraglutide. In animal studies, this medication has been found to raise the risk of thyroid C-cell tumors, but it is not known if this applies to humans. 

Why this approval matters

GLP-1 medications are very effective for the treatment of Type 2 diabetes and obesity. Other medications in this class include Saxenda (liraglutide), Ozempic (semaglutide), Wegovy (semaglutide), Mounjaro (tirzepatide), and Zepbound (tirzepatide), among others. The popularity of these medications created a surge in demand, which led to shortages of some GLP-1 receptor agonists that began in 2022. The approval of the generic version of Victoza should help expand access for people who need this type of medication.

“We are very pleased to launch liraglutide injection immediately upon receiving U.S. FDA approval, providing U.S. healthcare professionals and patients with this important generic treatment of diabetes,” Dr. Bill Larkins, President of Injectables for Hikma Pharmaceuticals, said in a statement. “This launch is the latest example of our actions to expand our portfolio in growing therapeutic areas like diabetes and to provide customers and patients with affordable access to a reliable supply of high-quality essential medicines.”

RELATED: Victoza alternatives

How much will generic Victoza cost?

Hikma Pharmaceuticals has not announced a price for the new generic liraglutide. The cost of the name-brand version varies, based on pharmacy and health insurance coverage. Coupons are available for generic Victoza through SingleCare, with the lowest price averaging around $94 for the 1, 3ml of 18mg/3ml pen of liraglutide.

Victoza coupons

When will generic Victoza be available?

Hikma Pharmaceuticals plans to make generic liraglutide available immediately in pharmacies across the U.S.