Teva wins FDA approval for first generic weight-loss drug

While most patients with commercial insurance pay around $30 monthly with manufacturer discount cards, those without coverage face the drug’s full list price.

By Aaron Sull, Jewish Breaking News

Millions of Americans struggling with obesity finally have access to an affordable weight-loss drug after Teva Pharmaceuticals won FDA approval for the first generic version of a highly effective medication.

The Israeli drugmaker announced it has received FDA clearance to sell generic liraglutide injection, a copy of Novo Nordisk’s expensive obesity drug Saxenda that currently costs patients over $1,300 per month.

“With this approval, and by launching a generic for Saxenda, we will provide patients in the U.S. the first ever generic GLP-1 product specifically indicated for weight loss,” said Ernie Richardsen, Teva’s senior vice president and head of U.S. commercial generics.

Saxenda generated $165 million in sales through June, representing a substantial market opportunity for Teva’s generic alternative.

While most patients with commercial insurance pay around $30 monthly with manufacturer discount cards, those without coverage face the drug’s full list price.

Liraglutide works by mimicking a hormone called glucagon-like peptide-1 that the body naturally produces in the small intestine when you eat.

This hormone performs several critical functions: it signals the brain when you’re full, slows down digestion so food stays in your stomach longer, and helps regulate blood sugar by triggering insulin release.

However, the body’s natural version only works for minutes after eating. Liraglutide stays active for 24 hours, requiring just one daily injection to maintain its appetite-suppressing effects.

Patients start with a small 0.6 mg dose that increases weekly until reaching the full 3 mg maintenance dose.

The medication slows digestion and reduces appetite, causing people to eat less and lose weight over time. Users must also follow reduced-calorie diets and increase physical activity.

Clinical trials involving 3,731 patients over 56 weeks showed impressive results. Three out of five people lost at least 5% of their body weight, while one in three achieved weight loss exceeding 10%.

FDA approval covers adults with obesity and those who are overweight with related health problems like diabetes or high blood pressure. Adolescents aged 12-17 who weigh more than 132 pounds and have obesity can also receive the medication.

Breaking into the GLP-1 market represents a significant achievement for Teva.

Manufacturing complex generic drugs like liraglutide requires sophisticated production capabilities that many competitors lack, giving the Israeli pharmaceutical giant an advantage in this lucrative space.

“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,” says Richardsen.

More than one-third of American adults suffer from obesity, creating enormous demand for effective treatments. Medical research shows losing just 5-10% of body weight significantly improves health outcomes and reduces risks of heart disease and diabetes.