FDA approves the first true generic of Victoza

The U.S. Food and Drug Administration announced on December 23, 2024 that it approved the first generic referencing Victoza (liraglutide injection) 18 mg/3 mL, a once-daily GLP-1 receptor agonist used to improve blood sugar control in adults and children ages 10 and older with type 2 diabetes, alongside diet and exercise ^[1]. The approval went to Hikma Pharmaceuticals USA Inc. ^[1].

Hikma said it launched the product immediately upon receiving approval, describing the same product as liraglutide injection in a 6 mg/mL concentration — the same strength the FDA lists as 18 mg per 3 mL pen ^[1][2]. The company's announcement was issued from London on December 26, 2024 ^[2]. Hikma cited IQVIA data showing U.S. sales of liraglutide injection, 6 mg/mL, of roughly $1.3 billion in the 12 months ending October 2024 ^[2].

A shortage drug moved to the front of the line

The FDA said liraglutide injection and certain other GLP-1 medications were in shortage at the time of the approval, and that the agency prioritizes review of generic applications for drugs in shortage to improve access ^[1].

This is the second generic GLP-1 the agency has cleared in a short span. The FDA said it approved the first generic in the class the prior month, a generic referencing Byetta (exenatide) ^[1].

Iilun Murphy, M.D., director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, said the agency "supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance," and that "generic drugs provide additional treatment options which are generally more affordable for patients" ^[1].

The FDA noted that complex products like liraglutide are harder to copy because of the active ingredient, the formulation or the delivery device, which is why many such drugs have lacked generic competition ^[1]. Hikma said it is a top three supplier of generic injectable medicines by volume in the U.S., with more than 170 products ^[2].

What the label says

The generic carries the same Boxed Warning as the brand about an increased risk of thyroid C-cell tumors ^[1]. Liraglutide caused dose-dependent and treatment-duration-dependent thyroid C-cell tumors in rats and mice at clinically relevant exposures; whether it does so in humans is unknown ^[2].

It is contraindicated in people with a personal or family history of medullary thyroid carcinoma, in people with multiple endocrine neoplasia syndrome type 2, and in those who have had a serious hypersensitivity reaction to liraglutide or its components ^[1][2]. The label also warns about pancreatitis, never sharing pens between patients, low blood sugar when combined with insulin or a sulfonylurea, acute kidney injury, hypersensitivity reactions, acute gallbladder disease, and rare reports of pulmonary aspiration during general anesthesia or deep sedation ^[1][2].

The most common side effects reported in clinical trials were nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation ^[1].

Why it matters for patients

A generic approval creates a second source of a medicine that was in shortage, which can matter for people who have had trouble filling prescriptions ^[1]. The FDA's general point is that generics tend to be more affordable, though neither the FDA release nor Hikma's announcement gives a U.S. list price, a cash price, or any details on insurance coverage or copays for this product ^[1][2]. How much patients actually pay is not yet known from these sources.

It is also worth being precise about what this approval covers. The generic is approved to improve blood sugar control in type 2 diabetes in adults and children 10 and older, as an add-on to diet and exercise ^[1][2]. It is not an approval for weight management, and the sources do not describe any weight-loss indication for this product.

Liraglutide is a different molecule from semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound), and it is taken once a day rather than once a week ^[1]. Nothing in these announcements changes the availability of those other drugs.

What happens next

The FDA said people should contact the manufacturer for information about availability ^[1]. Hikma said the launch happened immediately after approval ^[2]. The sources do not say how much supply Hikma can produce, whether other generic liraglutide applications are pending, or when the liraglutide shortage listing might be resolved.