Teva launches generic Saxenda, the first generic GLP-1 approved for weight loss

Teva Pharmaceuticals announced on Aug. 28, 2025 that the FDA approved a generic version of Saxenda and that the product, liraglutide injection, launched in the U.S. the same day ^[1][3]. Teva said it is the first generic GLP-1 specifically indicated for weight loss in the U.S. market ^[1][3]. A report in Drug Topics described liraglutide as the first GLP-1 to have a generic equivalent for both the type 2 diabetes and obesity indications ^[2].

Teva cited Saxenda annual sales of $165 million as of June 2025 ^[1][3]. "With this approval, and by launching a generic for Saxenda (liraglutide injection), we will provide patients in the U.S. the first ever generic GLP-1 product specifically indicated for weight loss," said Ernie Richardsen, senior vice president and head of U.S. commercial generics at Teva ^[1][3]. He said the launch was the fifth first-to-market entry of a Teva generic this year ^[1][3].

What the approval covers

According to the labeling described in Teva's announcement, liraglutide injection is approved for use along with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in two groups: adults with obesity or with overweight plus at least one weight-related medical condition, and children ages 12 to 17 who weigh more than 60 kg and have obesity ^[1][3]. The label says it is not known whether the drug is safe and effective in children under 12, or in patients ages 12 to 17 who have type 2 diabetes ^[1][3]. It is not recommended for people who also take liraglutide or other GLP-1 receptor agonists ^[1][3].

Safety information in the label

Liraglutide injection carries a boxed warning about possible thyroid C-cell tumors, including cancer. In studies in rats and mice, liraglutide and medicines that work like it caused thyroid tumors, including thyroid cancer; whether it causes thyroid tumors or medullary thyroid carcinoma in people is not known ^[1][3]. The label says the drug should not be used by people who have had medullary thyroid carcinoma themselves or in their family, or who have the endocrine condition MEN 2 ^[1][3].

Common side effects listed for adults include nausea, diarrhea, constipation, vomiting, injection site reactions, low blood sugar, headache, indigestion, fatigue, dizziness, stomach pain and a change in blood lipase levels; children may also have fever and gastroenteritis ^[1][3]. Serious risks listed include pancreatitis, gallbladder problems including gallstones, low blood sugar (especially in people with type 2 diabetes who take insulin or sulfonylureas), increased resting heart rate, dehydration leading to kidney problems, severe stomach problems, serious allergic reactions, and depression or thoughts of suicide ^[1][3]. A separate report lists the most common adverse reactions as gastrointestinal, including nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation, and cites risks of C-cell tumors, acute pancreatitis, acute gallbladder disease, hypoglycemia, elevated heart rate, kidney impairment, allergic reactions, and suicidal behavior and ideation ^[2].

Background

Liraglutide was first approved in 2010 for type 2 diabetes and in 2014 for obesity, and in 2020 for children 12 and older with obesity ^[2]. In April 2025, a generic equivalent of liraglutide was approved for type 2 diabetes and launched the same month by Meitheal Pharmaceuticals ^[2]. The GLP-1 market has grown sharply and is projected to double within the next decade, Becky Davis, a principal at Charles River Associates, said at the Asembia AXS25 Summit, according to that report ^[2].

Why it matters for patients

Until now, the FDA-approved GLP-1 medicines used for weight management in the U.S. were brand-name products. A generic version of liraglutide gives patients and prescribers another FDA-approved option, and generic entry is typically how drug prices fall over time. Teva has not disclosed what the generic will cost, and pricing has not been reported ^[1][3]. Whether insurers will cover it, at what tier, and what patients will pay at the pharmacy counter has not been disclosed either.

Liraglutide is a different medicine from semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound); generic versions of those products have not been reported. The label says liraglutide injection is not recommended for people who also take liraglutide or other GLP-1 receptor agonists, so the new generic is not a way to add a second GLP-1 to an existing regimen ^[1][3]. The approval also applies to a defined group: adults with obesity, or with overweight plus a weight-related medical condition, and certain adolescents 12 and older ^[1][3].

What happens next

Teva said the launch happened the same day as the approval, but did not announce supply volumes, a list price, or insurance coverage plans ^[1][3]. No further dated milestones have been disclosed.