Eli Lilly is aggressively ramping up its manufacturing capacity for tirzepatide as compounding pharmacies continue to challenge an FDA decision to formally end the shortage of the obesity and diabetes drug.
Eli Lilly on Thursday unveiled a new $3 billion manufacturing investment, a move that will help the pharma shore up the production of its blockbuster obesity and diabetes injection tirzepatide as compounders continue to challenge the drug’s supply status.
Lilly will use the money to expand its facility in Kenosha County, Wisconsin, boosting its global manufacturing network for injectable products. The company expects this expansion to help it meet the massive and growing demand for its diabetes and obesity medications, marketed as Zepbound and Mounjaro, respectively, while also preparing for future pipeline therapies across different disease areas.
The new facility will open 750 new jobs for highly skilled employees in Kenosha County, Wisconsin. Construction of the plant, set to start next year, will create more than 2,000 additional jobs throughout its duration. It is not yet clear when Lilly expects the construction to finish.
In a statement on Thursday, Edgardo Hernandez, Lilly’s executive vice president of Manufacturing Operations, said that the Wisconsin commitment is the pharma’s “single largest U.S. manufacturing investment outside of our home state of Indiana.”
Thursday’s announcement brings Lilly’s total investment in Wisconsin to $4 billion—and bumps the pharma’s global manufacturing commitments to $23 billion since 2020. Just this year, for instance, Lilly has dropped more than $10 billion to bump up its production capacity. This includes a $5.3 billion injection into its manufacturing site in Lebanon, Indiana, in May 2024, money that is specifically earmarked to boost its tirzepatide supply.
A few months later, in October 2024, Lilly added $4.5 billion into its Indiana investments, this time committing the funds to erect a new integrated facility for manufacturing and R&D. The Lilly Medicine Foundry, as the pharma calls this new facility, is expected to be operational in late 2027 and will create around 400 new jobs.
Lilly also announced a $1.8 billion manufacturing infusion in Ireland in September 2024.
The pharma’s aggressive investments in manufacturing come as the FDA remains undecided about the shortage status of tirzepatide—leaving the door open for compounders to continue producing and selling their copycat versions of the weight-loss drug.
In October 2024, the FDA formally took tirzepatide off its drug shortage list. A few days later, however, the trade group Outsourcing Facilities Association, which represents FDA-registered compounding pharmacies, sued the regulator, saying that declaring the end of the tirzepatide shortage was a “reckless” and “arbitrary” decision that lacked “any semblance of lawful process.”
More importantly, according to the trade group, the FDA’s declaration could “deprive patients of a vital treatment for type 2 diabetes and obesity.”
As per a court update last month, the FDA has yet to arrive at a final decision regarding tirzepatide’s shortage status—though it has “made substantial process” on the matter. The next court status report is due on December 19.
