Amid steadily increasing demand for Eli Lilly’s popular diabetes med Mounjaro, it appears patients on multiple dose strengths may have to wait even longer than anticipated to re-up on supply.
The FDA on Monday extended its estimated shortage duration for the drug in its 15-mg, 12.5-mg, 10-mg and 7.5-mg dose strengths to reflect “limited availability” through the end of this month. The shortage for several strengths was previously expected to persist through March.
Two lower dose strengths, 5 mg and 2.5 mg, are listed as available on the FDA's shortage database. However, even those are currently marked as unavailable on Amazon Pharmacy, a third-party dispensing provider for Lilly.
The FDA attributed the supply squeeze to demand increases, a familiar story for Lilly and fellow GLP-1 drug maker Novo Nordisk.
Last week, Bloomberg News reported that pharmacies across the nation were struggling to keep obesity shot Zepbound, Lilly’s other tirzepatide-based product, on the shelves. While that med isn’t listed on the FDA’s current shortage list, five out of the six dose strengths are similarly unavailable on Amazon Pharmacy.
The company acknowledged that some patients may struggle to fill their prescriptions due to “the unprecedented demand for these medicines,” a Lilly spokesperson recently told Fierce Pharma.
To address the issue, the drugmaker is “moving with purpose and urgency to ensure our innovations are available to those who need them,” the spokesperson added.
The latest Mounjaro shortage is reminiscent of last July's supply issues, when the same four dosing options landed on the FDA shortage list.
Lilly has long been trying to increase manufacturing output and in November was “aggressively planning” further production capacity, CEO David Ricks said on the company’s third-quarter earnings conference call.
Later that month, the company unveiled plans to build a $2.5 billion injectables plant in Germany, which is expected to be operational by 2027.