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The U.S. Food and Drug Administration updated its drug shortage database on Friday, showing that the all doses of Eli Lilly’s weight loss and diabetes drugs Zepbound and Mounjaro are now available.
Skyrocketing demand for Zepbound and other weight loss drugs like Wegovy have transformed Eli Lilly and Novo Nordisk into the most valuable pharmaceutical companies in the world. However, increased demand has also made it difficult for some patients to get their prescriptions filled.
Mounjaro was first added to the FDA’s drug shortage list in 2022, while Zepbound was officially declared in limited supply this April.
The news could threaten sellers of off-brand or compounded versions of the medication. Wall Street estimates that the market for these copy-cat drugs has likely reached $1 billion, Bloomberg reports.
However, as of today, the FDA still lists Zepbound and Mounjaro in shortage and says it is working with Eli Lilly to ensure a steady supply of the popular drugs.
The regulator told Reuters that even when all doses of a drug are found to be available, there are other requirements that need to be fulfilled for a drug to be removed from the list, including whether backorders are being fulfilled.
This has left the door open for pharmacists and telehealth platforms to sell cheaper versions of the highly coveted treatments.
When a medication is in shortage, the FDA allows pharmacies to make compounded, or altered, versions of the drug if they meet specific regulatory requirements. However, the agency does not review the safety and efficacy of these products.
Still, some healthcare companies are going all-in on compounded weight loss drugs.
The millenial-skewed telehealth platform Hims & Hers, which sells compounded versions of Ozempic and Wegovy, recently added Kåre Schultz, a longtime Novo Nordisk executive, to its board of directors.
Schultz told Bloomberg that the company has a “long future” in selling compounded semaglutide, the active ingredient in Wegovy. When asked if pharmacies will still be able to make compounded semaglutide after the shortages end, Schulz said he wasn’t worried because there would still be cases where patients need individualized prescriptions.
The FDA expects doses of Wegovy to be in limited supply indefinitely.