Most Doses of Lilly’s Zepbound and Mounjaro in Short Supply Through Q2: FDA

Eli Lilly_iStock, jetcityimage

Pictured: Eli Lilly's logo on top of its building in Indianapolis/iStock, jetcityimage

Eli Lilly’s type 2 diabetes drug Mounjaro (tirzepatide) and weight-loss medication Zepbound (tirzepatide) will have limited availability through the second quarter of 2024, according to an update to the FDA’s drug shortages database.

The shortage will affect Mounjaro’s 5-mg, 7.5-mg, 10-mg, 12.5-mg and 15-mg doses. Only its lowest strength of 2.5-mg will not have its availability impeded through the second quarter. The same is true for Zepbound—only its 2.5-mg dose will not be in shortage, while all other strengths will have limited availability.

According to the FDA’s website, the shortages are due to “demand increase for the drug.”

Lilly’s type 2 diabetes drug Trulicity (dulaglutide) will also be in short supply through May 2024 due to strong demand, according to the FDA database. The injection’s 1.5-mg, 3-mg and 4.5-mg strengths will be affected, leaving only its 0.75-mg dose with unrestricted availability.

"While we anticipate limited availability in the near term, we expect our investments in manufacturing and supply capacity to progressively increase production of our medicines throughout 2024 and beyond," a Lilly spokesperson told Reuters in a statement.

The FDA already announced earlier this month that some strengths of Mounjaro would be in shortage, also due to strong demand. At the time, only the 7.5-mg, 10-mg, 12.5-mg and 15-mg doses were affected, and the shortage was expected to persist through April 2024. Reuters also reported in February 2024 that the three highest strengths of Mounjaro would have limited availability through March.

Mounjaro and Zepbound are GLP-1 receptor agonists, which respectively treat type 2 diabetes and help manage weight by triggering the secretion of insulin from the pancreas in response to blood sugar levels. Mounjaro won the FDA’s approval in May 2022 for type 2 diabetes and Zepbound, indicated for chronic weight management with diet and exercise, followed in November 2023.

Lilly invested $2.5 billion in November 2023 to boost its manufacturing capacity in Germany, with a heavy focus on the production of its diabetes and obesity products. The new facility will add around 1,000 job openings for skilled workers. The plant is set to begin construction this year.

The company also announced in its fourth-quarter 2023 report that it was actively investing in its manufacturing capabilities, particularly as it advances orforglipron, its next-generation oral weight-loss candidate.

Novo Nordisk, which currently dominates the lucrative obesity market alongside Lilly, is also boosting its manufacturing capacities. In November 2023, the pharma made a $6 billion investment to increase its production capability in Denmark. Earlier this year, it dropped $16.5 billion to buy CDMO giant Catalent.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Back to news