Lilly's Tirzepatide is no longer on the FDA's drug shortage list

The FDA announced Wednesday that all doses of Eli LillyTirzepatide to treat obesity – known as Mounjaro for type 2 diabetes and Zepbound for weight control –are now available.

However, some pharmacies may experience limited supplies for patients, according to the FDA drug shortages website. This was due to a variety of “factors,” the regulator explained, such as the ordering practices and incentives of certain pharmacies, as well as retailer capacity limitations and logistical considerations related to the supply chain.

“Patients may experience fluctuations at a particular pharmacy location regardless of whether a drug is in short supply,” the FDA said.

The FDA's offering update on Wednesday comes after Lilly struggled for months to keep up with the market's insatiable appetite for its incretin therapies. In April 2024, the regulator announced that the 7.5 mg, 10 mg, 12.5 mg and 15 mg doses of Mounjaro would be available would have limited availability this month, largely due to an increase in demand.

Later that same month, the FDA has expanded its shortage reportalso covers the 5 mg dose of Mounjaro as well as all but the lowest strength of Zepbound. At the time, the regulator expected the shortage to last until the second quarter of 2024.

Evan Seigerman, an analyst at BMO Capital Markets, called Wednesday's confirmation that there is no longer a shortage of tirzepatide “another positive sign” for Lilly's growing incretin portfolio in a note to investors.

“Given Lilly's ability to adequately meet current and future demand for tirzepatide, we believe the company could further expand its market share in incretin products as production continues to expand,” Seigerman wrote.

The FDA's announcement Wednesday “further confirms that Lilly's offering strength could benefit the company as it heads toward third-quarter earnings,” said Seigerman, who also noted that compounded products could no longer be sold since tirzepatide is no longer available is on the regulatory authority's bottleneck list.

To secure its supply of tirzepatide, Lilly has invested heavily in its production capacity.

On Wednesday, Lilly a $4.5 billion investment for the construction of a new facility in Indiana that will house both research and development and manufacturing activities. The new site, called Lilly Medicine Foundry, will allow the pharmaceutical company to develop “innovative solutions” to optimize its production processes while increasing its overall drug capacity for clinical trials.

The Lilly Medicine Foundry is expected to open in late 2027 and, once fully operational, will create approximately 400 new jobs for engineers, scientists, laboratory technicians and operations staff.

In May 2024, Lilly made a $5.3 billion commitment to Indiana to support a “multi-site campus” dedicated to producing its products, including Zepbound and Mounjaro, CEO David Ricks said in a statement at the time. Last month, Lilly has pumped $1.8 billion into its presence in Ireland to increase its production capacity.

Meanwhile, obesity rival Novo Nordisk still appears to be struggling with its semaglutide supply. According to the FDA database, the 0.25 mg dose of Novo's weight loss drug is Wegovy still in short supply.

Like Lilly, Novo has made significant investments in manufacturing, including Acquisition of Catalent valued at $16.5 billion in February and a $4.1 billion commitment in North Carolina in June.