- Tirzepatide, the active ingredient in Zepbound and Mounjaro, is no longer in short supply, the FDA says.
- Cheaper versions of the drug, known as compounded tirzepatide, might be restricted in 2025.
- Patients could face higher costs and tougher access, and telehealth is racing to adapt.
The FDA has announced that popular weight loss medication tirzepatide is no longer in shortage, potentially removing cheaper versions of the drug from the market by early 2025.
Tirzepatide is the active ingredient in Eli Lilly's drugs Mounjaro and Zepbound, branded to treat diabetes and obesity, respectively.
They're part of a class of medications called GLP-1 agonists, including semaglutide (sold as Ozempic and Wegovy), which have transformed obesity treatment in recent years. These injections work by mimicking hormones in the body that regulate appetite and blood sugar, helping patients lose as much as 25% of their body weight.
Manufacturers have struggled to meet the intense demand for these drugs. This opened the door for pharmacies to offer custom-made versions with the same active ingredient, known as compounded GLP-1 medication, at a significantly lower cost — around $250 to $350 per month for tirzepatide, compared to Zepbound's list price of $1,059.
With the official shortage over, the FDA has signaled it will crack down on compounded tirzepatide, affecting patients who've relied on the lower-priced medication.
"People are concerned. They're saying, 'This has been life changing but I don't have $1000 to pay out of pocket and my insurance isn't going to cover it," Ted Kyle, a health professional with decades of experience in policy, marketing, and obesity care, told Business Insider.
Eli Lilly did not immediately respond to Business Insider's request for comment.
Most compounded versions of tirzepatide won't be allowed without an official shortage
The FDA's annoucement on December 19 to officially remove tirzepatide from the shortage list means compounding pharmacies will be restricted from making what are essentially copies of the brand-name version. These copies use the same active ingredient — in this case tirzepatide — but are not FDA-approved, although the manufacturers are held to other regulatory standards.
Compounding pharmacies have staunchly disagreed with the decision.
"The drugs they are advertising are not yet available in quantities to meet demand. Until they are, state-licensed pharmacies will continue to prepare compounded copies, operating within FDA guidance to provide patients access to life-changing medications during this period when the drugmakers cannot," Scott Brunner, CEO of the industry trade group Alliance for Pharmacy Compounding, wrote in a statement on LinkedIn.
The FDA had previously moved to end the shortage in October, but delayed the decision after a compounding industry organization filed a lawsuit alleged it hadn't given proper notice. An update on that case is expected in early January 2025.
As it stands now, the FDA's decision will give makers of compounded tirzepatide up to 90 days before enforcement to "avoid unnecessary disruption to patient treatment," per the announcement.
Companies are racing to adapt
The FDA decision also raises questions for the booming telehealth industry that connects patients with weight loss drugs, as companies like Henry Meds and Hims offer compounded GLP-1s — some have removed compounded tirzepatide from their websites.
For now, businesses will still be able to offer some lower-cost medications for weight loss since semaglutide, better known as Wegovy and Ozempic, is still considered to be in shortage.
In some cases, telehealth execs are pivoting to strike a deal with pharmaceutical companies.
Earlier in December, telehealth company Ro announced a partnership with Eli Lilly to offer a half-price version of Zepbound, Lilly's brand-name tirzepatide product. The cheaper option is sold in vials in an effort to sidestep supply-chain issues with the prefilled pens and compete with compounded drugs.
More brand-name GLP-1 drugs are on the horizon
More FDA news could continue to change the trajectory of GLP-1 drugs in the coming months.
The FDA also announced the approval of the first generic version of a once-daily GLP-1 injection for Type 2 diabetes on December 24. It could pave the way for similar generic medications, including those for weight loss.
And more brand name GLP-1s are in the works as biotech startups and pharmaceutical companies race to find the next blockbuster medication.
For now, access to weight loss drugs is out of reach for many people who could benefit from them.
"This is going to be a continuing tension for years to come," Kyle said. "Maybe compounding will go away but the issue won't go away because the pricing does not match the scale of need."