Months of an ongoing supply squeeze for Eli Lilly’s tirzepatide-based meds have lifted, according to the FDA.
After placing nearly all doses of the company’s diabetes drug Mounjaro and its obesity counterpart Zepbound on the agency’s shortage list in April, all doses of the meds are now listed as available. Mounjaro’s first appearance on the list was all the way back in 2022.
The shortage, which has been attributed to fervent demand outweighing supply, has caused the company to pour billions into extra supply capacity. By the end of the first quarter, seven sites expected to help ease the supply woes were either “ramping up or under construction,” chief financial officer Anat Ashkenazi said on a previous earnings call.
That includes a North Carolina plant expected to come online by the end of the year and a Germany site slated to become operational in 2027, among others. In May, the company pumped an additional $5.3 billion into a massive Indiana manufacturing complex, bringing the total investment in the 600-acre site $9 billion as the largest outlay in United States history for synthetic medicine active pharmaceutical ingredient manufacturing, CEO David Ricks said at the time.
Near- to mid-term sales for the blockbuster drugs were previously said to come down to the amount of product the company could produce and ship out, Lilly said on its first-quarter call, making the supply issue a crucial one to solve.
Just last week, CEO Ricks predicted that the shortage would end “very soon,” the chief told Bloomberg News in an interview. “I think actually today or tomorrow we plan to exit that process,” he added. At the time, the two doses of Zepbound and two of Mounjaro were listed on the shortage list to be limited availability through July, according to Bloomberg.
Still, all doses of Mounjaro and Zepbound are currently still listed as unavailable on Lilly’s third-party dispensing provider Amazon Pharmacy.
Meanwhile, obesity competitor Novo Nordisk still has some doses of its rival obesity drug Wegovy on the FDA shortage list. Three of the Wegovy doses are marked as “limited availability” with an estimated shortage duration listed as “TBD” due to demand increases.
Shortages of both obesity meds have led to an increase in compounded and counterfeit versions of Wegovy and Zepbound. Lilly in May settled with a Charleston, South Carolina med spa after suing several companies who were selling unauthorized versions of its products.