FDA Approves First Generic GLP-1 Liraglutide for Weight Loss

The FDA approved a liraglutide injection, which is the generic version of Saxenda, for adults with obesity and overweight with weight-related medical issues and patients aged 12 through 17 years with a weight greater than 60 kg. Generic liraglutide is the first-ever generic glucagon-like peptide-1 (GLP-1) indicated for weight loss.¹

Liraglutide is the first glucagon-like peptide-1 to have a generic equivalent for both type 2 diabetes and obesity indications. | Corona Borealis - stock.adobe.com

“With this approval, and by launching a generic for Saxenda (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 is a GLP-1 indicated for type 2 diabetes (Victoza) and obesity (Saxenda). It was initially approved in 2010 and 2014, respectively. Then, in 2020, it was approved for pediatric patients 12 years and older with obesity. Prescriber and pharmacist collaboration is essential to patient outcomes and to making sure that patients receive their medication at a reasonable cost.²

The most common adverse reactions with liraglutide are gastrointestinal in nature, including nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation. However, serious adverse effects have been reported, including risk for C-cell tumors, acute pancreatitis, acute gallbladder disease, hypoglycemia, elevated heart rate, renal impairment, hypersensitivity reactions, and suicidal behavior and ideation.²

In April 2025, a generic equivalent to liraglutide was approved for type 2 diabetes, and it was launched in the same month by Meitheal Pharmaceuticals.³

The GLP-1 market recently experienced unprecedented growth, and it is projected to double within the next decade, according to Becky Davis, principal at Charles River Associates, at a session at Asembia’s AXS25 Summit. Although the class has been around since 2005, the spike in popularity impacted the market for diabetes drugs, expanding into other disease states such as obesity, chronic kidney disease, and cardiovascular health.⁴

With that, a lot of manufacturers are launching direct-to-consumer programs where patients can buy the medication directly from the manufacturer, bypassing their usual pharmacy. In April 2025, Novo Nordisk announced a partnership with a variety of direct-to-consumer platforms for semaglutide, the company’s popular GLP-1 medication.⁴

“There's some research that shows that direct-to-consumer advertising of drugs might increase patient requests for these drugs and also the likelihood that they're going to be prescribed by doctors,” Jenny Markell, PhD candidate of health and public policy at the Johns Hopkins Bloomberg School of Public Health, said. “If we're seeing more spending on these drugs, it could, in terms of their advertising, be a marketing strategy to increase prescriptions of those drugs and increase demand for those drugs.”

READ MORE: Obesity Management Resource Center

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REFERENCES

1. Teva announced FDA approval and launch of generic Saxenda (liraglutide injection) – first generic GLP-1 indicated for weight loss. News release. Teva. August 28, 2025. Accessed August 28, 2025. https://www.globenewswire.com/news-release/2025/08/28/3140801/0/en/Teva-Announces-FDA-Approval-and-Launch-of-Generic-Saxenda-liraglutide-injection-First-Generic-GLP-1-Indicated-for-Weight-Loss.html

2. Cerillo JL, Parmar M. Liraglutide. [Updated 2024 Oct 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK608007/

3. Gallagher A. FDA approves generic liraglutide for type 2 diabetes. Drug Topics. April 3, 2025. Accessed August 28, 2025. https://www.drugtopics.com/view/fda-approves-generic-liraglutide-for-type-2-diabetes

4. Gallagher A. Projection estimated GLP-1 market to nearly double by the end of decade | Asembia 2025. Drug Topics. May 1, 2025. Accessed August 28, 2025. https://www.drugtopics.com/view/projection-estimates-glp-1-market-to-nearly-double-by-end-of-decade-asembia-2025

5. Nowosielski B, Turnock L, Markell J. Deciphering the increase in direct-to-consumer drug advertising. Drug Topics. May 16, 2025. Accessed August 28, 2025. https://www.drugtopics.com/view/deciphering-the-increase-in-direct-to-consumer-drug-advertising