Tirzepatide (Mounjaro, Zepbound) Is Off the Shortage List: Here’s What That Means for You
Key takeaways:
Tirzepatide is an injectable medication. It’s sold as Mounjaro for Type 2 diabetes and as Zepbound for weight loss. Due to increased demand, tirzepatide injections went into shortage in December 2022.
The tirzepatide injection shortage was first resolved in October after the FDA determined that the manufacturer could meet market demand. After being challenged, the FDA upheld its decision in December 2024.
Based on prior deadlines, the FDA no longer allows pharmacies or physicians to regularly compound or dispense compounded tirzepatide injections.
If you’ve been using compounded tirzepatide, talk to your prescriber about your options. You may be able to switch to Mounjaro or Zepbound, depending on your health history and insurance coverage.
Table of contents
In October 2024, the FDA indicated that the supply of Mounjaro and Zepbound can now meet the market demand. This marked the end of the tirzepatide shortage that began nearly 2 years prior. And after giving the shortage status a second look, the FDA upheld this decision in December 2024. This is a positive development, but some people are now finding themselves in a complicated situation.
During the shortage, compounded versions of tirzepatide injections became a temporary solution for many people. However, this practice is no longer widely allowed once the shortage resolves. If you rely on compounded tirzepatide, you may be wondering how this news impacts your prescription. Here’s what you should know.
Why was tirzepatide in shortage?
The main driver of the tirzepatide shortage was increased demand. This was due to its growing popularity for weight loss. Zepbound is approved for weight loss and obstructive sleep apnea (OSA). Mounjaro is approved for Type 2 diabetes, but it’s often prescribed off-label for weight loss.
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Here’s the tirzepatide shortage timeline:
May 2022: The FDA approved Mounjaro for Type 2 diabetes.
December 2022: Mounjaro was listed as being in shortage due to increased demand.
November 2023: The FDA approved Zepbound for weight loss.
April 2024: Zepbound was listed as being in shortage due to increased demand.
October 2024: Mounjaro and Zepbound are no longer in shortage according to the FDA. This decision was challenged, and the FDA agreed to take a second look.
December 2024: The FDA upheld its decision that the tirzepatide shortage is officially resolved. The agency also approved Zepbound for moderate-to-severe OSA.
What does it mean now that tirzepatide is off the shortage list?
When the FDA removes a medication from the shortage list, it has determined that the manufacturer is able to meet the market demand. In the case of Mounjaro and Zepbound, the FDA reviewed supply and market sales data in reaching this determination. The agency also considered information from patients, healthcare professionals, and pharmacies.
Even though tirzepatide is off the shortage list, Zepbound and Mounjaro may not be readily available at all pharmacies right away. In this case, it’s a good idea to call for refills earlier than usual to ensure the medication is in stock. If needed, you can also try calling other pharmacies if you’re unable to fill your prescription.
But what about compounded tirzepatide? Some pharmacies were making compounded versions of Zepbound and Mounjaro during the shortage. This means they were sourcing ingredients and making the injections from scratch. Now that the shortage is resolved, the FDA no longer permits this practice, with limited exceptions.
Will compounded tirzepatide injections still be available?
Generally, no.
How they compare: Zepbound and Mounjaro are two injectable medications that contain tirzepatide. Here’s how they compare.
GLP-1 discounts: Medications like Zepbound, Mounjaro, and Wegovy (semaglutide) don’t have to break the bank. Explore your options with this GLP-1 savings guide.
Zepbound coverage: Before starting Zepbound, it’s a good idea to have cost and insurance coverage details.
After the FDA upheld its decision in December, the agency has given pharmacies a grace period to phase out compounded tirzepatide injections. These deadlines have since passed. This means that, as of now, tirzepatide injections can no longer be compounded on a regular basis, except in some limited cases based on medical need.
Tips for managing your tirzepatide prescription
You may have been told that you can no longer fill your compounded tirzepatide prescription. In this case, you’ll likely need to switch to a commercial product if you want to continue treatment. Here are a few tips to help you make the switch:
Talk to your healthcare team as soon as possible. They can help determine whether Mounjaro (for Type 2 diabetes) or Zepbound (for weight loss or OSA) is appropriate for you based on your health history and goals.
Ask about insurance coverage. Coverage varies by plan and other criteria. So check whether your insurer covers Mounjaro or Zepbound and what documentation is required.
Explore savings programs. Lilly, the manufacturer of both Mounjaro and Zepbound, offers copay cards and savings programs that may reduce your out-of-pocket costs.
Be prepared for a new titration schedule. If you switch from compounded tirzepatide, your prescriber may recommend restarting at a lower dose. This may be more likely if you were receiving a non-standard tirzepatide dose or dosage form before.
Call for refills earlier. Once you’ve switched to Mounjaro or Zepbound, it may be a good idea to request refills a little earlier. This gives your pharmacy more time to secure the medication and avoid potential delays.
Avoid buying tirzepatide online. It’s possible to receive a counterfeit version of Mounjaro or Zepbound, especially if you buy them online. Be wary of any deals that sound too good to be true. Not sure if your product is the real thing? Scan your barcode with this tool.
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How to save on Mounjaro and Zepbound
Most people pay a cash price for compounded tirzepatide, which is often lower than Mounjaro or Zepbound. If you’re switching to an FDA-approved medication, check with your insurance plan to see if it’s covered first.
Mounjaro may be covered if you have Type 2 diabetes. And Zepbound may be covered if you meet certain body mass index criteria or have moderate-to-severe OSA. Check with your specific plan to learn more. If your costs are still high, or if you’re uninsured, here are a few other ways to save on your prescription:
Mounjaro copay savings card: Pay as little as $25 for a 1- or 3-month supply of Mounjaro pens.
Zepbound copay savings card: If Zepbound is covered by your commercial insurance plan, you could pay as little as $25 for a 1- or 3- month supply of Zepbound pens. If your commercial insurance doesn’t cover Zepbound, you could pay as little as $650 for a 1-month supply.
Zepbound vials: Zepbound vials are available at a reduced cost through LillyDirect. The cost of a 1-month supply is $349 (2.5 mg) or $499 (5 mg, 7.5 mg, 10 mg).
GoodRx coupons: Save an average of $200 per month on Mounjaro and $210 per month on Zepbound with GoodRx.
The bottom line
After nearly 2 years, the FDA has determined that the tirzepatide (Mounjaro, Zepbound) shortage has been resolved. This means that the supply from the manufacturer is able to meet market demand.
If you had been using compounded tirzepatide, you can speak to your prescriber about switching to Mounjaro or Zepbound. Be sure to check with your insurance plan to see if they’re covered. Copay savings cards can help make your prescription more affordable. There are also lower-cost Zepbound vials available through LillyDirect.
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References
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Eli Lilly and Company. (2024). Lilly releases Zepbound (tirzepatide) single-dose vials, expanding supply and access for adults living with obesity.
National Association of Boards of Pharmacy. (2024). Injectable weight loss drugs illegally sold online pose danger to patients.
Outsourcing Facilities Association. (2024). Outsourcing Facilities Association sues FDA over sudden removal of tirzepatide from drug shortage list.
Pierson, B. (2024). US FDA to reconsider decision barring compounded versions of Lilly weight loss drug. Reuters.
U.S. Food and Drug Administration. (2022). Information for outsourcing facilities.
U.S. Food and Drug Administration. (2023). Frequently asked questions about drug shortages.
U.S. Food and Drug Administration. (2024). Compounding when drugs are on FDA’s drug shortages list.
U.S. Food and Drug Administration. (2024). Declaratory order: Resolution of shortages of tirzepatide injection products (Mounjaro and Zepbound.
U.S. Food and Drug Administration. (2024). FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize.
U.S. Food and Drug Administration. (2024). FDA drug shortages: Tirzepatide injections.
