The Zepbound Shortage Is Over — Here's What to Expect if You've Been Using an Off-Brand Version

Mar. 15, 2025

Eli Lilly’s weight loss drug Zepboundis no longer in short supply, the FDA said.

On Thursday, Dec. 19, the U.S. Food and Drug Administration announcedin a statementthat after two years of being in shortage, tirzepatide — the active ingredient in Zepbound and its counterpart Mounjaro for diabetes — is fully available again.

“FDA has determined that the shortage of tirzepatide injection products, which first began in December 2022, is resolved,” the agency said, perCNBC. “FDA continues to monitor supply and demand for these products.”

Weight loss drugs that use tirzepatide as the active ingredient cost around $1,000 per month without insurance, while off-brand alternatives can be more affordable, according toBusiness Insider. Alternatives for tirzepatide can cost around $250 to $350.

Now that the shortage is over, specialty and compounding pharmacies must stop selling their off-brand versions of theweight-loss drugs.

In a statement to PEOPLE, an Eli Lilly spokesperson said, “FDA’s decision reiterating that the tirzepatide shortage is resolved reflects the tireless work of our manufacturing and quality colleagues to safely expand our manufacturing capacity to bring these medicines to people who need them.”

The FDA has also cited overdoses as a concern, as it has received reports of patients giving themselves the incorrect dose of off-brand drugs. Compounded drugs are not FDA approved, which means the agency does not verify their safety, effectiveness or quality.

“These dosing errors resulted from patients measuring and self-administering incorrect doses of the drug, and in some cases, health care professionals miscalculating doses of the drug,” the FDA said in a statement, noting that some of these overdoses may be related to the off-brand drugs having different formulas than name brands.

Never miss a story — sign up forPEOPLE’s free daily newsletterto stay up-to-date on the best of what PEOPLE has to offer​​, from celebrity news to compelling human interest stories.

Eli Lilly and other drug companies have also been attempting to crack down on off-brand versions of its weight loss drugs, suing medical spas, compounding pharmacies and weight loss clinics, according to CNBC.

In turn, an organization representing compounding pharmacies, called the Outsourcing Facilities Association, sued the FDA in October, CNBC reported, over its decision to remove tirzepatide from the drug shortages list several days prior. The pharmacies alleged that the FDA ignored evidence that showed there is still a tirzepatide shortage. The FDA quickly responded, saying it would leave tirzepatide on the list for a period of time as they reevaluated, allowing the compounding pharmacies to keep making the drugs.

Telehealth companyRohas a new partnership with Eli Lilly to offer ahalf-price version of Zepboundthat will be sold in vials, according to Business Insider. The move aims to sidestep supply-chain issues with the prefilled pens.

Eli Lilli shared the following statement with PEOPLE:

“Anyone marketing or selling unapproved tirzepatide knockoffs must stop. FDA makes clear that its decision will help ‘protect patients from unnecessary exposure to drugs that have not been shown to be safe and effective.’ FDA was also clear that compounders must immediately begin transitioning patients taking compounded tirzepatide knockoffs to FDA-approved tirzepatide medicines. This decision is a critical step towards protecting patients from the dangers of counterfeit and compounded knockoffs, and we commend FDA and other state and federal regulators that are taking action against those who put American patients at risk. Resolving the tirzepatide shortage alone is not enough, regulators and law enforcement must remain vigilant and take decisive action against those that threaten the health and wellbeing of Americans.”

source: people.com