Generic Mounjaro, Zepbound May Be Coming, Rivaling Current GLP-1s

• Federal regulators have agreed to review the applications from Swiss pharmaceutical company Sandoz for two cheaper generic versions of the tirzepatide medications Zepbound and Mounjaro.
• Eli Lilly’s patents on those two brand-name drugs are valid in the United States until 2036, but they are expiring in other countries.
• Experts say a less expensive version of these GLP-1 medications would give more people access to these effective weight-loss drugs.

Some less expensive versions of the GLP-1 medications Mounjaro and Zepbound are now officially in the government approval pipeline.

The U.S. Food and Drug Administration (FDA) has agreed to review two applications from Swiss manufacturer Sandoz to develop generic versions of those brand-name medications, both of which contain the active ingredient tirzepatide.

The FDA hasn’t specified how long this process will take, but on its website, the agency states that it typically completes reviews of standard drug applications within 10 months.

Sandoz has requested approval of their generic medications for the same uses as Mounjaro and Zepbound, which are manufactured by Eli Lilly.

Mounjaro is approved as a treatment for type 2 diabetes, while Zepbound is authorized as a treatment for obesity as well as sleep apnea.

The Sandoz generic drugs would be taken as a weekly injection, just like Zepbound and Mounjaro. Both are intended to be prescribed along with a lifestyle plan that includes a healthy diet and regular exercise.

The generic medications are expected to be less expensive than Mounjaro and Zepbound. Those brand-name drugs can cost more than $1,000 per month if they aren’t covered by insurance. Sandoz estimates its product will cost between $200 and $400 per month without insurance.

Generic medications tend to be cheaper because the pharmaceutical companies that make them don’t have to fund the initial scientific research that the brand-name companies conducted.

“Sandoz is building its GLP-1 development platform, and this submission reflects true in-house innovation,” said Claire D’Abreu-Hayling, the president of Generics Development and the chief scientific officer at Sandoz, in a press statement.  “It represents a key first step in our efforts to bring this medicine to market and underscores our ambition to increase competition and expand affordability in a critical area of healthcare need.”

Eli Lilly has patent protection in the United States for Mounjaro and Zepbound until 2036. That means generic tirzepatide drugs cannot be sold in the U.S. until the patent expires unless a company gets special permission from the FDA or a court.

There was an exception made to these restrictions in December 2022 when the FDA declared there was a shortage of GLP-1 medications and allowed compounded versions of these drugs to be sold by telehealth providers.

However, the FDA ruled in December 2024 that the GLP-1 medication shortage had ended and compounded versions were no longer allowed to be sold.

Generic GLP-1 medications could lower cost, improve access

There is an intense race among pharmaceutical companies to enter the GLP-1 medication market, especially in countries outside the United States, where patents are expiring.

In June, Canadian health officials approved a generic version of Novo Nordisk’s Wegovy medication to be used as a treatment for weight loss.

Wegovy is a weekly injection that contains the active ingredient semaglutide. The new generic drug is Sevian, an injectable medication manufactured by Canada-based Apotex.

Canadian officials said they are also reviewing applications for six other generic medications with the ingredient semaglutide. One of them is Sandoz’s generic version of Ozempic that would be prescribed as a treatment for type 2 diabetes.

Experts said generic GLP-1 medications should help reduce prices and boost supply.

“It could be significant. The biggest obstacle for the medications is the cost,” said Pouya Shafipour, MD, a family and obesity medicine physician at Providence Saint John’s Health Center in California.

“It’s a breakthrough to have tirzepatide available that is safe,” he told Healthline.

Mir Ali, MD, a bariatric surgeon and the medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in California, added that insurance companies might be more likely to cover these less expensive brands. He said the generic drugs should also perform similarly to the brand-name medications.

“For the most part, they should be just as effective,” he told Healthline.

Ali noted that having a larger supply of GLP-1 medications on pharmacy shelves is beneficial to everyone.

“These are very effective medications as a tool to lose weight,” he said. “Access is still an issue for these effective medications.”

Clare Thompson, MD, a general practitioner who leads weight management services at the Cadogan Clinic in London, agrees.

“Generic tirzepatide medications would drastically reduce costs, ease global shortages, and drive wider adoption of dual-agonist therapies (targeting both GLP-1 and GIP receptors), resulting in greater HbA1c reduction and weight loss overall,” she told Healthline.

“Generic alternatives to Mounjaro would expand access to millions of patients and lift the burden on public health services and private insurance,” Thompson added.

How GLP-1 medications can help treat diabetes and obesity

The newer GLP-1 medications basically work by suppressing appetite and managing blood sugar levels.

Some of the drugs are approved to treat obesity, while others are authorized to treat type 2 diabetes.

Most medications are available as once-weekly injections. However, two daily oral tablet versions have been approved by the FDA this year. They are a pill version of Wegovy manufactured by Novo Nordisk and, Foundayo, a tablet manufactured by Eli Lilly.

GLP-1 medications are effective in helping people lose weight and manage blood sugar levels. In addition, the drugs have been shown to also improve heart health.

The medications do have side effects. Some of the common ones are:

• Nausea
• Headache
• Stomach pain
• Heartburn
• Dizziness
• Mood changes

Experts say it’s important for people prescribed GLP-1 medications to recognize that the drugs are part of a long-term treatment plan that involves lifestyle factors such as a balanced, healthy diet and regular aerobic and strength exercise.

“These medications are designed to treat obesity as a long-term disease,” said Ali.

“Weight loss is not a quick fix,” added Shafipour. “It requires behavioral changes.”

Shafipour noted lower cost generic GLP-1 medications can help people stick with their weight management plans.

“If generics are affordable, then people can stay on them,” he said.

Dace Trence, MD, a professor emeritus of medicine at the University of Washington and the president of the American Association of Clinical Endocrinology, concurs that a chief benefit of generic GLP-1 medications is their cost-effectiveness.

“Cost remains the major barrier to access of these drugs, or if started, the ability to continue to use them. We have learned that these drugs must be continued for the person to benefit from them,” Trence told Healthline.

“There has been shown benefit on lowering blood pressure, improving blood cholesterol, often leading to less medication needed for the treatment of these conditions,” she added. “There has also been impact on decreasing the chance of developing or recurrent cardiovascular disease such as heart attacks or stroke.”