Tirzepatide (Mounjaro, Zepbound) Is Off the Shortage List: Here’s What That Means for You

In October 2024, the FDA indicated that the supply of Mounjaro and Zepbound can now meet the market demand, officially ending thetirzepatide shortage. Initially starting in December 2022, the shortage lasted nearly 2 years. This is a positive development, but some people are now finding themselves in a complicated situation.

The end of the shortage doesn't necessarily mean that Mounjaro and Zepbound are now readily available at all pharmacies across the country. And compounded versions of tirzepatide injections - which provided people options during the supply crunch - are no longer widely allowed.

If you rely on compounded tirzepatide, you may be wondering how this news impacts your prescription. Below, we cover what this shortage resolution means, the status of compounded tirzepatide, and potential options to consider.

EXPERT PICKS: WHAT TO READ NEXT

• Knowing the risks:Compounded products can help people access certain medications that are in shortage. But before trying compounded diabetes and weight-loss injections, it's a good idea tounderstand the potential risks.
• How they compare:Medications like Zepbound and Wegovy (semaglutide) work by mimicking the effects of gut hormones called incretins. Here'show they compare.
• Mounjaro vs. Zepbound:Mounjaro and Zepbound are injectable medications that both contain tirzepatide. Here are thekey things to know when comparing them.

Why was tirzepatide in shortage?

The main driver of the tirzepatide shortage was increased demand. This was due to its growing popularity forweight loss. Zepbound is approved for weight loss. Mounjaro is approved for Type 2 diabetes, but it's often prescribedoff-labelfor weight loss.

Here's the tirzepatide shortage timeline:

• May 2022:The FDAapproved Mounjarofor Type 2 diabetes.
• December 2022:Mounjaro was listed as being in shortage due to increased demand.
• November 2023:The FDA approved Zepbound for weight management.
• April 2024:Zepboundwas listedas being in shortage due to increased demand.
• October 2024:Mounjaro and Zepbound are no longer in shortage according to the FDA.

What does it mean now that tirzepatide is off the shortage list?

In October 2024, the FDA indicated that the tirzepatide injection shortage was resolved.

When the FDA removes a medication from the shortage list, ithas determinedthat 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.

But does this mean that Mounjaro and Zepbound are now readily available at every pharmacy across the U.S.? Not necessarily. It can take some time for these products to reach pharmacies as they make their way through the supply chain. So you may need to call around to find one that has it in stock.

Will compounded tirzepatide injections still be available?

The short answer: Not really.

During a shortage, the FDA has provisions thatmay allowpharmacies to makecompounded versionsof medications. This can help ensure people still have access to treatment while the commercial medication is in short supply. In these cases, pharmacies source the active ingredient(s) and make the medications from scratch.

While Mounjaro and Zepbound were in shortage, some pharmacies were makingcompounded tirzepatide injections- usually at a much lower price. But it's important to note that compounded medications don't go through the same testing as FDA-approved medications. So their safety and effectiveness haven't been evaluated. Plus, there can be variability in the quality of medication you receive, depending on where you fill your prescription.

According to the FDA, the widespread compounding of tirzepatide injections isno longer permittedunder normal circumstances now that the shortage has resolved. For most compounding pharmacies, this change goes into effect right away. FDA-registered compounding pharmacies - calledoutsourcing facilities- have a 60-day grace period to fulfill existing (but not new) orders.

But this doesn't mean that compounded tirzepatide will go away entirely. There may be certain situations where your prescriber determines that it's appropriate for you, such as in the case of an allergy. Keep in mind that the FDA doesn't consider cost to be a reason for compounding copies of FDA-approved medications.

What can you do if you can't fill your compounded tirzepatide prescription?

It's completely understandable to feel frustrated when you're suddenly unable to fill your prescription. You may be tempted to buy tirzepatide medications from online pharmacies. But keep in mind that there's ahigher chancethat you'll receive acounterfeit product. Be wary of any deals that sound too good to be true.

Instead, the best next step is to reach out to your primary care provider about your options. Or if a telehealth provider had prescribed compounded tirzepatide for you, they may be able to switch you to Mounjaro or Zepbound. This can take some time, and you may not be able to access these medications right away. And for some, cost can remain a significant barrier.

A similar medication, semaglutide (Ozempic,Wegovy), is still being compounded due to shortages. Butcompounded semaglutidehas unique risks to consider andmay not be as effectiveas FDA-approved tirzepatide. You can discuss the potential benefits and risks of your personal situation with your prescriber. And keep in mind that the same thing will happen whenever the semaglutide injection shortage has resolved.

How to save on Mounjaro and Zepbound

Most people pay a cash price for compounded tirzepatide, which is often lowerthan MounjaroorZepbound. 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. 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:Payas little as $25for a 1- or 3-month supply of Mounjaro pens.
• Zepbound copay savings card:If Zepbound is covered by your insurance, you could payas little as $25for a 1- or 3- month supply of Zepbound pens. If your insurance doesn't cover Zepbound, you could pay as little as $650 for a 1-month supply.
• Zepbound vials:Zepbound vials are availableat a reduced costthroughLillyDirect. A 1-month supply for 2.5 mg vials is $399 and for 5 mg vials is $549.

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" data-qa="ContentCalloutH2Title" 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. Pharmacies are also no longer able to regularly make compounded tirzepatide injections, with few exceptions.

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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