It’s been nearly a year since Novo Nordisk revealed a supply shortfall for its obesity blockbuster-to-be Wegovy. Now, it appears history is repeating for the company’s chief rival, Eli Lilly.
Eli Lilly’s incretin-based diabetes meds Trulicity (dulaglutide) and Mounjaro have run scarce in the U.S., according to the FDA’s online drug shortage database.
For the dual GIP/GLP-1 med Mounjaro, which Lilly is positioning to eventually challenge Wegovy in obesity, the FDA says 5-mg/0.5-ml doses remain available, “though pharmacies may experience delays in receiving full shipments" through January.
The same is true for 3-mg and 4.5-mg strengths of Trulicity. While shipments are ongoing for both drugs, the FDA has warned of “intermittent periods of backorder” because of high demand.
In Mounjaro’s case, the FDA credited the uncertain supply landscape to the “dynamic nature of this new product launch.” The agency pointed out that several dosage strengths are still available.
"We are in frequent contact with the FDA to provide timely updates, and remain committed to supplying Mounjaro for people with type 2 diabetes," an Eli Lilly spokesperson said over email.
Still, the company warned the supply squeeze was coming.
Back in early November, executives said that limited availability of rival drugs—read, Novo’s Ozempic and Wegovy—helped fuel an exceptional earnings period for Lilly’s diabetes meds. During the third quarter, Trulicity and Mounjaro brought home $1.85 billion and $187.3 million in sales, respectively, with Mounjaro handily beating revenue estimates of $81 million.
At the same time, however, the company cautioned that the demand spike had stressed the company's ability to meet “expanding demand” for Trulicity in “most international markets.”
To cope with the supply squeeze, Michael Mason, EVP and president of Lilly Diabetes, said the company was “taking actions to maximize production supply for our current facilities while we ramp up our new manufacturing facilities.” He cautioned analysts on the call that “weekly production forecasts [on Mounjaro] won’t perfectly align with demand each week.”
The intense demand for both Novo and Lilly’s drugs seems to be fueled, at least in part, by off-label use of GLP-1 drugs for aesthetic weight loss, which has garnered mainstream media attention in recent months. Novo’s Wegovy is approved for obesity specifically, while tirzepatide has yet to secure a weight loss nod from the FDA.
Aside from high demand, Novo also suffered a contract manufacturing snafu earlier in Wegovy's obesity launch.
In the U.S., Novo has said it expects to have all Wegovy strengths back on before the year is out. Across the pond, the company recently launched its therapy in its home market of Denmark.
Even still, both Ozempic and Wegovy, which are different dosage strengths of the same molecule semaglutide, continue to populate the FDA’s drug shortage roster.
Editor's note: This story has been updated with a comment from Eli Lilly.