
FDA-Approved Generic GLP-1: What It Means for Ozempic Prices and Shortages
The first generic GLP-1 drug for weight loss has been approved, but it is not a generic version of Ozempic. In August 2025, the FDA approved Teva Pharmaceuticals' generic version of liraglutide (Saxenda), which is in the same GLP-1 drug class as Ozempic but is a different medicine.
While this development increases competition within the GLP-1 class, it is not a direct generic for semaglutide (Ozempic, Wegovy) and comes with specific substitution limits that may restrict its ability to ease the Ozempic shortage or lower its price significantly.
Key Takeaways
- The first FDA-approved generic GLP-1 is for weight loss (liraglutide), not a direct generic for Ozempic.
- A generic liraglutide is a different drug than Ozempic (semaglutide) and is not an automatic substitute.
- The national shortage of Ozempic (semaglutide) has been declared over by the FDA.
- Drug price competition is increasing, but direct pressure on Ozempic's price requires a generic semaglutide.
- Always consult your doctor before making any changes to your prescribed diabetes or weight-loss medication.
Are there already FDA approved generic GLP-1 drugs in the same class as Ozempic?
Yes, the U.S. Food and Drug Administration (FDA) has approved a generic drug in the GLP-1 class. However, it is crucial to understand exactly what has been approved.
Teva Pharmaceuticals received FDA approval in late August 2025 for the first generic GLP-1 medication specifically indicated for weight loss . This generic is a version of liraglutide injection, previously marketed as Saxenda. It is approved for adults with obesity or overweight with at least one weight-related condition, and for pediatric patients aged 12 years and older with obesity .
This is not the first generic GLP-1 overall. In June 2024, Teva launched a generic version of liraglutide 1.8 mg (Victoza), which is indicated for improving glycemic control in type 2 diabetes . Another company, Hikma Pharmaceuticals, also received approval for a generic liraglutide for type 2 diabetes in December 2024 .
The table below summarizes the current landscape of generic GLP-1 approvals.
| Generic Drug Name | Brand Name It Copies | FDA Approval Date | Primary Indication |
|---|---|---|---|
| Liraglutide Injection | Saxenda | August 2025 | Weight Loss |
| Liraglutide | Victoza | June 2024 | Type 2 Diabetes |
| Liraglutide | Victoza | December 2024 | Type 2 Diabetes |
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Could a generic in the GLP-1 drug class bring down the price of Ozempic for diabetes treatment?
The arrival of a generic GLP-1 can increase competition, but its direct impact on the price of Ozempic is expected to be limited. This is because the newly approved generic is liraglutide, not semaglutide (the active ingredient in Ozempic). They are different medications within the same class.
Market competition is already putting pressure on drugmakers. In March 2025, Novo Nordisk significantly reduced the list price of its weight-loss drug Wegovy (semaglutide) from $1,349 to $499 per month. The company applied a similar discount to Ozempic in August 2025 . This strategy was a response to competition from other branded products, like Eli Lilly's tirzepatide, and the growing market for cheaper compounded versions .
The potential for price reductions exists, but it operates within a complex system. A generic liraglutide provides a lower-cost alternative for weight loss, which could pressure other weight-loss drug prices. However, for a patient specifically prescribed Ozempic for type 2 diabetes, a generic liraglutide is not a substitute. True, direct price pressure on Ozempic will likely only occur when a generic version of semaglutide itself becomes available.
What’s the difference between a brand-name GLP-1 like Ozempic and a generic in the same class?
Understanding the distinction between a generic and a different drug in the same class is key for patients.
A true generic drug contains the same active ingredient as its brand-name counterpart. For example, a generic Ozempic would also contain semaglutide. The recent approval, however, is for a generic liraglutide, which is a different molecule that works in a similar way by mimicking the GLP-1 hormone . Think of them as cousins, not twins.
Key Differences to Know:
- Active Ingredient: Ozempic contains semaglutide. The new generic contains liraglutide .
- FDA Approval and Safety: Both brand-name and generic drugs undergo rigorous FDA review for safety, effectiveness, and quality. The FDA has approved generic liraglutide as a safe and effective version of brand-name Saxenda . This is different from compounded drugs, which are not FDA-approved and can have variable quality .
- Efficacy and Dosing: While both are GLP-1 receptor agonists, they have different clinical profiles and dosing schedules. Patients cannot assume they are interchangeable without consulting their doctor.
How do substitution limits work for GLP-1 generics in the class of Ozempic?
Substitution rules for GLP-1 drugs are strict and vary by state, which affects how easily a patient can access a generic alternative.
For many traditional pills, a pharmacist can automatically substitute a brand-name drug for an FDA-approved generic if your doctor allows it on the prescription. However, GLP-1 drugs like liraglutide and semaglutide are biologics, not simple chemical drugs. Their "generics" are more accurately called biosimilars or simply generic biologics .
The FDA has a specific designation for biosimilars called "interchangeable." This means a pharmacist can substitute it for the brand-name product without contacting the prescriber, similar to traditional generics . However, the newly approved generic liraglutide has not been designated as interchangeable with Saxenda. This means a pharmacist cannot automatically substitute it. Your doctor must specifically prescribe the generic liraglutide for you to receive it.
Furthermore, a prescription for Ozempic (semaglutide) can never be substituted with liraglutide (Saxenda or its generic) by a pharmacist. They are different drugs with different active ingredients. Any switch would require a new prescription from your healthcare provider.
Will the introduction of a generic GLP-1 drug ease the Ozempic shortage for diabetes patients?
The introduction of a generic GLP-1 is unlikely to have a major impact on the Ozempic shortage because they are different drugs. The good news is that the Ozempic shortage itself has largely been resolved.
In February 2025, the FDA officially declared that the shortage of semaglutide injection (Ozempic) was over, after confirming that manufacturer capacity can meet national demand . While there may be intermittent, localized supply disruptions as products move through the distribution chain, the widespread national shortage has ended .
With the shortage resolved, the FDA has ended its enforcement discretion for compounded semaglutide. As of April 22, 2025, for state-licensed pharmacies, and May 22, 2025, for outsourcing facilities, compounding semaglutide is no longer permitted under the shortage exemption . This means patients and providers are expected to shift back to FDA-approved products, which should further stabilize the supply.
It is important to note that as of late February 2025, the FDA still listed liraglutide injection (the drug that was just generically approved) as being in shortage, with some of its presentations having limited availability .
What should you ask your doctor if a generic GLP-1 in the same class as Ozempic becomes available?
Having an informed conversation with your doctor is the best way to navigate your treatment options. If cost or availability is a concern, here are some key questions to ask during your next appointment:
- "Is a generic GLP-1 like liraglutide an appropriate alternative for my specific health condition?" Remember, a generic liraglutide is approved for weight loss, while Ozempic is primarily for type 2 diabetes. Your doctor can assess if it is a suitable medical alternative for you.
- "What are the key differences in effectiveness, side effects, and dosing between my current medication and this generic?" Understanding the clinical differences can help you manage your expectations and treatment.
- "If we switch, will my insurance cover it, and what will my out-of-pocket cost be?" Insurance formularies can be complex. Your doctor's office can often help you navigate prior authorizations, and you should contact your insurer for the exact copay information.
- "Could my current prescription be written to allow pharmacist substitution if an interchangeable biosimilar becomes available in the future?" This proactive question ensures you are ready to access lower-cost options as soon as they hit the market.
- "Given that the Ozempic shortage is over, should I expect any more difficulties filling my prescription?" This opens a dialogue about local pharmacy access and ensures you have a reliable supply.
Frequently Asked Questions
As of May 22, 2025, the FDA no longer permits compounding pharmacies to produce semaglutide under the drug shortage exemption. Patients are expected to transition back to FDA-approved products.
An FDA-approved generic has been reviewed for safety and effectiveness and is a copy of the brand-name drug. A compounded drug is custom-made by a pharmacy, is not FDA-approved, and its safety and quality can vary.
Yes. The FDA is actively promoting policies to accelerate the development of lower-cost biosimilar and generic alternatives to expensive biologic drugs like GLP-1s.
Potentially. The Trump administration has expressed a goal to dramatically reduce drug prices, mentioning GLP-1s specifically, but such price cuts are not yet a done deal and would involve complex negotiations.
It could be, but only if prescribed by your doctor for a medically appropriate reason. You must discuss with your healthcare provider whether liraglutide is a suitable treatment for your condition.




