Teva Pharmaceuticals announced FDA approval and immediate U.S. launch of a generic version of Saxenda (liraglutide injection), marking the first generic GLP-1 receptor agonist specifically indicated for weight loss. The approval addresses growing demand for weight management therapies in a market where the reference drug generated $165 million in annual sales 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."
Approved Indications and Patient Population
The generic liraglutide injection received approval for weight management in combination with reduced calorie diet and increased physical activity for two specific patient populations. Adults with obesity or overweight who have at least one weight-related comorbid condition qualify for treatment. The approval also extends to pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity.
The drug is not recommended for patients already taking liraglutide or other GLP-1 receptor agonists. Safety and effectiveness have not been established in children under 12 years of age or in children aged 12 to 17 years with type 2 diabetes.
Safety Profile and Contraindications
The generic liraglutide injection carries a boxed warning regarding potential thyroid tumors, including cancer. Studies in rats and mice showed that liraglutide and similar medications caused thyroid tumors, including thyroid cancer, though it remains unknown whether this risk applies to humans.
The drug is contraindicated in patients with personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Additional serious side effects include pancreatitis, hypoglycemia risk (particularly in patients with type 2 diabetes taking insulin or sulfonylureas), increased heart rate, dehydration leading to kidney problems, and gallbladder problems.
Common side effects in adults include nausea, diarrhea, constipation, vomiting, injection site reactions, hypoglycemia, headache, dyspepsia, fatigue, dizziness, and stomach pain. Pediatric patients may additionally experience fever and gastroenteritis.
Strategic Significance
This approval represents a significant milestone in Teva's Pivot to Growth Strategy, focusing on complex generic medicines. The launch adds to Teva's portfolio of specialized generic products and demonstrates the company's capability to develop and commercialize challenging formulations in high-demand therapeutic areas.
The generic entry into the GLP-1 weight loss market comes at a time of increased demand for obesity treatments, potentially improving patient access through reduced costs compared to branded alternatives. Teva's ability to secure first-to-market status reflects the technical complexity involved in developing generic versions of biologics and complex injectable medications.
