FDA says every dose of Mounjaro and Zepbound is available again

All doses of Eli Lilly's weight-loss injection Zepbound and its diabetes drug Mounjaro — both tirzepatide — are now listed as available in the U.S. Food and Drug Administration's drug shortage database, according to an update posted Friday ^[1][2]. An earlier version of the database had said some doses of the two drugs were still in short supply ^[1].

The change does not mean the drugs are off the shortage list. Reuters reported that the FDA had not yet removed tirzepatide from the list, and the agency said in an email that it "continues to actively monitor drug availability and work with the company to ensure a stable supply of safe and effective drugs" ^[2]. The FDA added that even when all doses of a drug are marked available, it weighs additional criteria before formally resolving a shortage, including whether backorders have been filled and whether supply is meeting demand ^[2].

How long the shortage lasted

Mounjaro has been on the FDA shortage list since late 2022 ^[2]; CNBC reported some doses had been in shortage as early as 2022 ^[1]. Zepbound, which the FDA approved for obesity in November 2023 ^[1], was added to the shortage list in April 2024 ^[2].

The database update landed one day after Lilly CEO David Ricks told Bloomberg that the shortages of Mounjaro and Zepbound would end "very soon." "I think actually today or tomorrow we plan to exit that process," he said ^[1]. A Lilly spokesperson told Reuters that "all doses of Mounjaro and Zepbound are listed as available on the FDA's website which is consistent with our previous statements that supply would steadily improve toward the latter half of 2024" ^[2]. Lilly did not immediately respond to CNBC's request for comment on the update ^[1].

Demand for these medicines has outstripped supply for months, pushing Lilly and rival Novo Nordisk to invest billions of dollars in expanding manufacturing ^[1][2]. GLP-1 therapies, originally developed for diabetes, have reduced weight by up to 20% in trials, and some analysts estimate the market could reach $150 billion in annual revenue by the early 2030s ^[2].

On the semaglutide side, several doses of Novo Nordisk's Ozempic and Wegovy have been on the FDA shortage list since early 2022 ^[2]. As of that same Friday, all doses of Ozempic were listed as available, while Wegovy still had limited supply — Reuters specified three doses remained limited, while CNBC described it more generally as "some doses" ^[1][2].

Why it matters for patients

For people filling tirzepatide prescriptions, an "available" listing is a signal about the national supply picture, not a guarantee about any particular pharmacy on any particular day. The FDA itself drew that distinction by keeping the drugs on the shortage list while it checks whether backorders have been cleared and supply is genuinely meeting demand ^[2].

The listing also matters because the shortage status is the formal record the FDA uses to describe the supply of a drug. These two sources do not address what the status change means for compounded versions of tirzepatide, for insurance coverage, or for pricing, so those consequences are not established here.

Patients on semaglutide should note that the picture was different on the same date: Ozempic was fully available, but some Wegovy doses were still limited ^[1][2].

What happens next

The next step would be the FDA formally removing tirzepatide from its shortage list, which the agency said depends on criteria beyond the availability of individual doses ^[2]. No date for that decision appears in these sources.

Lilly has said supply would "steadily improve toward the latter half of 2024" ^[2], but the sources do not include specific production figures, timelines for individual dose strengths, or a projection for when Wegovy's remaining limited doses will return to full availability. Whether supply stays stable as demand keeps rising is not answered by this update.