Hikma launches the first FDA-approved generic of Victoza

The U.S. Food and Drug Administration approved the first generic version of Victoza, the once-daily GLP-1 injection used to treat type 2 diabetes, on December 23, 2024 ^[2]. Hikma Pharmaceuticals launched its generic liraglutide injection in the U.S. immediately after receiving approval, the company said on December 26, 2024 ^[1].

The generic matches Victoza's 18 milligram/3 milliliter formulation, dosed at 6 mg/mL, and is approved for adults and children 10 years and older with type 2 diabetes, used along with diet and exercise ^[1][2]. Liraglutide works by mimicking GLP-1, a hormone the body doesn't produce in sufficient amounts in people with type 2 diabetes ^[2]. According to the Centers for Disease Control and Prevention, more than 38 million Americans have diabetes, and 90% to 95% of those cases are type 2 ^[2].

Brand-name Victoza generated about $1.3 billion in U.S. sales in the 12 months ending October 2024, according to IQVIA data cited by Hikma ^[1]. This approval follows the FDA's approval of the first generic exenatide, which references Byetta, the previous month, marking the second generic GLP-1 medication to reach the market ^[2].

The FDA noted that liraglutide and certain other GLP-1 medications are currently in shortage, and the agency prioritizes generic drug applications for medications in shortage to help improve patient access ^[2]. Iilun Murphy, director of the FDA's Office of Generic Drugs, said the agency supports development of complex generic drugs like GLP-1s through funding and guidance, adding that "generic drugs provide additional treatment options which are generally more affordable for patients" ^[2].

Why it matters for patients

A generic liraglutide option means patients with type 2 diabetes may have another avenue to access this GLP-1 medication, particularly amid ongoing shortages of liraglutide and related drugs ^[2]. Generic drugs are typically more affordable than brand-name versions, though the sources do not specify the actual retail price of Hikma's generic ^[1][2].

The generic carries the same boxed warning as brand-name Victoza regarding the risk of thyroid C-cell tumors, based on animal studies; it is not known whether liraglutide causes these tumors in humans ^[1][2]. The drug is contraindicated for people with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 ^[1][2]. Other warnings include risks of pancreatitis, hypoglycemia when combined with insulin or sulfonylureas, kidney impairment, hypersensitivity reactions, and acute gallbladder disease ^[1]. The most common side effects reported in clinical trials include nausea, diarrhea, vomiting, decreased appetite, dyspepsia and constipation ^[2].

This approval is specific to liraglutide, the active ingredient in Victoza (and Saxenda, a related brand for weight management not mentioned in these sources). It does not apply to semaglutide products like Ozempic, Wegovy, or Rybelsus, or to tirzepatide products like Mounjaro or Zepbound, which remain distinct medications under separate patent and approval status according to the sources provided.

What happens next

The FDA granted approval to Hikma Pharmaceuticals USA Inc., and the company has already begun distribution, though the sources do not detail a specific timeline for when the generic will be widely available at U.S. pharmacies or its exact retail cost ^[1][2]. The FDA noted this approval is part of its broader Drug Competition Action Plan aimed at increasing generic competition, particularly for complex drug products like GLP-1 injections ^[2]. Whether additional manufacturers will receive approval for generic liraglutide, or how the launch will affect the ongoing liraglutide shortage, is not addressed in the available sources ^[2].