- Tirzepatide, the active ingredient in Zepbound and Mounjaro, is no longer in short supply, the FDA says.
- Cheaper versions of the drug, known as compound tirzepatide, could be phased out in 2025.
- Patients may face higher costs and tougher access, and telehealth is struggling to adapt.
The FDA has announced that the popular weight-loss drug 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 brand-name diabetes and obesity drugs Mounjaro and Zepbound, respectively.
They are part of a class of drugs 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 up to 25% of their body weight.
Manufacturers have struggled to meet the intense demand for these drugs. That opened the door for pharmacies to offer custom-made versions with the same active ingredient, known as the compounded GLP-1 drug, at a significantly lower cost — about $250 to $350 a month for tirzepatide, compared with Zepbound list price of $1,059.
With the official shortage over, the FDA has signaled it will crack down on compounded tirzepatide, affecting patients who have relied on lower-priced drugs.
“People are worried. They say, ‘This is life-changing, but I don’t have $1,000 to pay out of pocket and my insurance won’t cover it,'” Ted Kyle, a health professional with decades of experience. in policy, marketing and obesity care, Business Insider said.
Eli Lilly did not immediately respond to Business Insider’s request for comment.
Most compounded versions of tirzepatide will not be allowed without an official exemption
The FDA’s Dec. 19 announcement to officially remove tirzepatide from the shortage list means that compounding pharmacies will be limited to 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 comply with other regulatory standards.
Compounding pharmacies have strongly contested the decision.
“The drugs they advertise are not yet available in quantities to meet demand. Until they are available, state-licensed pharmacies will continue to prepare compounded copies, working within FDA guidelines to provide patients with access in life-changing medications during this period when drugmakers can’t,” Scott Brunner, CEO of the industry trade group Alliance for Compounding Pharmacywrote in a statement on LinkedIn.
The FDA had previously moved to end the shortage in October, but delayed the decision after a complex industry organization filed a lawsuit alleging it failed to provide adequate notice. An update on that case is expected in early January 2025.
As it stands now, the FDA’s decision will give compounded tirzepatide manufacturers up to 90 days before implementation to “avoid unnecessary interruption of patient treatment,” according to the release.
Companies are racing to adapt
The FDA’s decision also raises questions about 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 weight loss drugs as semaglutide, better known as Wegovy and Ozempic, is still considered to be in short supply.
In some cases, telehealth executives are trying 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 tirzepatide product. The cheaper option is sold in bottles in an attempt to circumvent supply chain problems with pre-filled pens and compete with compounded drugs.
More branded GLP-1 drugs are on the horizon
More news from the FDA could continue to change the trajectory of GLP-1 drugs in the coming months.
The FDA also announced approval of the first generic version of a once-daily GLP-1 injection for type 2 diabetes on December 24. This could pave the way for similar generic drugs, including for weight loss.
And more GLP-1 brands are in the works as biotech startups and pharmaceutical companies race to find the next blockbuster drug.
Right now, access to weight loss drugs is out of reach for many people who could benefit from them.
“This is going to be an ongoing tension for years to come,” Kyle said. “Perhaps the composition will go away, but the issue will not disappear because the price does not match the scale of the need.”