FDA Approves Generic Version of Liraglutide Injection, a GLP-1 for Weight Loss

The FDA has approved the launch of a generic version of liraglutide injection (Saxenda; Teva Pharmaceuticals Inc.). This action marks the drug as the first-ever generic glucagon-like peptide 1 (GLP-1) receptor agonist indicated for adults with obesity or overweight who also have a weight-related medical problem and pediatric patients aged 12 to 17 years with a weight greater than 60 kg and obesity specifically to aid weight loss and keep the weight off.¹

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“With this approval, and by launching a generic for [liraglutide injection], we will provide patients in the US the first ever generic GLP-1 product specifically indicated for weight loss,” Ernie Richardsen, senior vice president and head of US commercial generics at Teva Pharmaceuticals, said in a news release.¹

Liraglutide Injection Indications

As a GLP-1 receptor agonist, liraglutide injection should be used in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain long-term weight reduction. The injection comes as a solution in a prefilled dosing pen to inject subcutaneously in the stomach, thigh, or upper arm, once daily with or without food. Liraglutide injection is also used to control blood sugar levels in certain patients with type 2 diabetes (T2D) and also reduced the risk of heart attack, stroke, or death in individuals with T2D and cardiovascular disease.²

Previous Study Results for Liraglutide

The originally approved injection for 3 mg liraglutide in adults and children with obesity and overweight was based on a 53-week trial including 3731 individuals with a body mass index (BMI) of 27 to 29.9 with at least 1 weight-related condition, or a BMI of at least 30—not including adults with T2D. A total of 2487 participants received a liraglutide injection, and 1244 received a placebo, while maintaining a reduced-calorie diet and physical activity counseling. The results demonstrated that 3 out of 5 individuals in the liraglutide group achieved significant weight loss of 5% or more, and 1 out of 3 individuals achieved weight loss of more than 10%.³

Patient Access With Generic GLP-1s

The generic version of the liraglutide injection is the first to be approved for weight management to treat adults and adolescents aged 12 and older who weigh over 60 kg and are obese. It can also be prescribed to adults who are overweight and have at least 1 weight-related medical condition. This medication should be used in combination with a reduced-calorie diet and increased physical activity; however, liraglutide injection is not recommended for individuals who are already taking liraglutide or other GLP-1 receptor agonists. The safety and effectiveness of liraglutide injection in children under 12, as well as in adolescents aged 12 to 17 with T2D, have not been established.¹

In 2024, the FDA approved the first generic referencing liraglutide injection (Victoza; Teva Pharmaceuticals, Hikma Pharmaceuticals) in 18 mg and 3 mL to improve glycemic control in adults and pediatric patients aged 10 years and older with T2D as an adjunct to diet and exercise. This approval was granted during a drug shortage for liraglutide, which helped improve patient access to this medication.³

“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 news release. "Generic drugs provide additional treatment options which are generally more affordable for patients."⁴

REFERENCES

1. Teva Announces FDA Approval and Launch of Generic Saxenda® (liraglutide injection) – First Generic GLP-1 Indicated for Weight Loss. Teva. News release. August 28, 2025. Accessed August 28, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Teva-Announces-FDA-Approval-and-Launch-of-Generic-Saxenda-liraglutide-injection--First-Generic-GLP-1-Indicated-for-Weight-Loss/default.aspx

2. Liraglutide Injection. MedlinePlus. Updated May 15, 2025. Accessed August 28, 2025. https://medlineplus.gov/druginfo/meds/a611003.html

3. Novo Nordisk. (n.d.). How it works. Saxenda. https://www.saxenda.com/about-saxenda/how-it-works.html

4. FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes. FDA. News release. December 23, 2024. Accessed August 28, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes