Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced Aug. 28 that a generic version of Saxenda 1 (liraglutide injection) has received FDA approval and will get a U.S. launch.
Liraglutide Injection is a glucagon like peptide 1 (GLP-1) receptor agonist indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in:
- Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity.
- Adults with overweight in the presence of at least one weight-related comorbid condition.
- Liraglutide injection should be used with a reduced calorie diet and increased physical activity.
- Liraglutide injection is not recommended for people who also take liraglutide or other medicines called glucagon-like peptide-1 (GLP-1) receptor agonists.
- It is not known if liraglutide injection is safe and effective in children under 12 years of age.
- It is not known if liraglutide injection is safe and effective in children aged 12 to 17 years with type 2 diabetes.
Serious side effects may happen in people who take liraglutide injection, including possible thyroid tumors, including cancer. It is not known if liraglutide injection will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Saxenda had annual sales of $165 million as of June 2025.
“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, SVP, Head of U.S. Commercial Generics at Teva.
“This is the fifth first-to-market entry of a Teva generic this year and is an important addition to Teva’s diverse complex generics portfolio, demonstrating once again our proven ability to sustain a world class Generics Powerhouse.”
