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Mounjaro generic availability, cost, and more

Here’s why generic Mounjaro will not be available for several years
Two tirzepatide pens: Mounjaro generic availability, cost, and more

Key takeaways

  • An FDA-approved generic Mounjaro will not be available for several years.

  • Compounded tirzepatide is not a generic form of Mounjaro, and per the FDA, compounded tirzepatide should no longer be distributed after March 2025.

  • Until generic Mounjaro is available, patients can save on Mounjaro with insurance coverage, SingleCare coupons, or patient assistance from Eli Lilly, the drug’s manufacturer.

Many people are interested in generic drug availability since brand-name drugs are often costly. Mounjaro (tirzepatide) is a brand-name prescription medication that is approved by the Food and Drug Administration (FDA) to improve blood sugar levels in people with Type 2 diabetes. It is also commonly used off-label for weight loss because, as a dual glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist, tirzepatide helps control appetite (and thereby facilitates weight loss) in addition to lowering blood sugar.

The FDA recently approved generic versions of two other GLP-1s, Victoza (liraglutide) and Byetta (exenatide). Given their change to a generic medication, it’s natural to wonder whether generic Mounjaro is next. Read on to learn when to expect a generic for Mounjaro, the difference between compounded tirzepatide and a true generic, and how to save on Mounjaro until a generic version becomes available.

Is there a generic for Mounjaro?

No, there is no generic approved drug of Mounjaro. 

“Mounjaro is relatively new, and I don’t expect an FDA approval for the generic version anytime soon,” says Mir Ali, MD, a bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, California.

Mounjaro is much newer than Victoza or Byetta, the GLP-1s that are now available in generic form. Dr. Ali says both those drugs have been around at least 12 years longer than Mounjaro,  which was approved for diabetes management in 2022 (it is still not FDA approved for obesity or weight management). Zepbound, another drug with the active ingredient tirzepatide, is approved for weight loss, but there is no generic for Zepbound either. There are also no generic alternatives for the GLP-1s Ozempic (semaglutide), Wegovy (semaglutide), or Trulicity (dulaglutide). 

When will a generic Mounjaro be available?

Generic versions of medications become available only after the brand-name drug’s patent and exclusivity rights expire. In the case of Mounjaro, the pharmaceutical company Eli Lilly holds a patent for both the medication and its injection delivery device

“In the United States, brand-name drugs are protected by patents for about 20 years, but companies often extend that through additional patents and exclusivity agreements,” explains Marlee Bruno, a certified physician’s assistant and the founder of Mind Body & Soul Medical in Pensacola, Florida. “A generic version [of Mounjaro] likely won’t be available until at least the early 2030s.”

While it’s not possible to predict exactly when a generic Mounjaro will be available, it’s safe to say that it will take several more years.

What’s the difference between Mounjaro and compounded tirzepatide?

Compounded tirzepatide is a custom-mixed version of Mounjaro’s active ingredient. As a brand-name drug, Mounjaro can cost more than $1,400 per month without insurance. Compounded tirzepatide may be available at a lower price, but insurance companies will not cover it because compounded tirzepatide products are not FDA approved.

“A lot of people assume compounded tirzepatide is just a cheaper, generic version of Mounjaro. It’s not,” emphasizes Bruno. 

So, why is compounded tirzepatide even available? The answer has to do with supply and demand. Pharmacies were allowed to start selling compounded tirzepatide because of a Mounjaro shortage. But in December 2024, the FDA announced that the tirzepatide shortage had ended. In an effort to minimize disruptions to patients’ treatment plans, the FDA has stated that pharmacists and distribution facilities were given until Feb. 18 and March 19, 2025, respectively, to continue selling tirzepatide without violating FDA guidelines. 

Below, find the main differences between Mounjaro and compounded tirzepatide.

FDA approval

Mounjaro is FDA approved for blood sugar management in people with Type 2 diabetes. Compounded tirzepatide is not FDA approved for any purpose.

“Compounded versions are made by compounding pharmacies, not drug manufacturers like Eli Lilly, and they don’t undergo the same rigorous FDA approval process,” Bruno says.

Dosage

Mounjaro is FDA approved as a weekly injection from a prefilled autoinjector pen. Dosages are standardized, with a starting dose of 2.5 mg per week. 

Compounded tirzepatide, on the other hand, comes in more than one form. Some compounding pharmacies offer oral compounded tirzepatide, while others sell vials that contain multiple doses and that must be drawn up into a syringe for proper weekly dosing. 

Safety

Ultimately, compounded tirzepatide is not tested for safety and efficacy like Mounjaro is. Compounded GLP-1s come with a risk of contamination, inaccurate dosing, and different results compared to their brand-name counterparts. Simply put, compounded tirzepatide might not be as safe or effective as Mounjaro because its manufacturing is not rigorously overseen like FDA-approved medications are.

Compare Mounjaro vs. compounded tirzepatide

Mounjaro Compounded tirzepatide
FDA approval Approved along with diet and exercise to improve blood sugar in adults with Type 2 diabetes mellitus

May be prescribed off-label for weight loss

Not FDA approved
Dosage 2.5 mg single-dose prefilled injection pen once weekly for four weeks, which is then increased to a maintenance dosage of 5 to 15 mg subcutaneously once per week Varies depending on the compounding facility 

Examples include:

  • Oral dissolving tablets in various dosages
  • Oral liquid drops in various dosages
  • Multiple-dose vials intended to be drawn up with a syringe and injected in once-weekly doses
Safety FDA approved as a safe and effective treatment for diabetes management when prescribed by a healthcare provider. The FDA and Mounjaro’s manufacturer have issued safety warnings about compounded tirzepatide and the risks of knockoff products. 

How to save on Mounjaro

There are ways to save on Mounjaro until it is available in a more affordable generic version. For instance, Bruno suggests looking into the income requirements for Eli Lilly’s patient assistance program. Changing insurance plans might also lower a person’s out-of-pocket cost. Cash payers can also save on Mounjaro with coupons from SingleCare, which lowers the cost from $1,469 to $846 for a four-week supply.

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