Eli Lilly builds $1.5B stockpile of weight loss pills ahead of FDA approval

Eli Lilly has stockpiled approximately $1.5 billion worth of “pre-launch inventory” for its investigational weight loss pill orforglipron, in advance of regulatory approval by the U.S. Food and Drug Administration (FDA), according to the drugmaker’s 2025 annual report.

Lilly has been busy building up the inventory of orforglipron — its first oral, small molecule GLP-1 receptor agonist — making significant progress in 2025 by adding $1 billion to its arsenal. Last year at this time, the pharmaceutical giant had stockpiled only $550 million worth of the pills, per the company’s 2024 annual report.

In 2025, Lilly received a Commissioner’s National Priority Voucher from the FDA for orforglipron for the treatment of obesity, which could accelerate potential U.S. approval timing. The drugmaker’s submission to the agency is under the expedited review pathway.

Among the factors Lilly considered, in deciding to build up a pre-launch inventory, were: orforglipron’s status in the regulatory approval process, potential impediments to the approval process, viability of commercialization, as well as market trends.

“When we believe that future commercialization is probable and the future economic benefit is expected to be realized, we capitalize pre-launch inventory prior to regulatory approval,” Lilly said in its 2025 annual report filed with the U.S. Securities and Exchange Commission.

Averting the risk of shortages

There have been recent periods of time when demand for Lily’s incretin medicines exceeded production. While there have been shortages and supply constraints for these injectable GLP-1 medicines, CEO Dave Ricks has said it will be “easier” for Lilly to manufacture orforglipron at scale in the U.S. because it is an oral drug.

Lilly’s goal is “when we introduce this product in 2026, we can do it globally in all countries simultaneously, virtually — and at scale without the risk of shortage,” according to Ricks.

Last year, Lilly pledged $27 billion to build four new U.S. pharmaceutical manufacturing sites — three for active pharmaceutical ingredients (APIs) and one to manufacture injectable products and devices. In December, Lilly announced plans to invest $6 billion in a new API manufacturing facility in Huntsville, Alabama that will produce small molecule synthetic and peptide medicines, including orforglipron.

A $6.5 billion API facility in Houston, Texas, announced in September, will focus on domestic production of small molecule synthetic medicines, including orforglipron. Lilly is also investing more than $1.2 billion to expand and modernize its site in Carolina, Puerto Rico, which will manufacture orforglipron.

Currently, Lilly’s major manufacturing sites include facilities in Indiana, North Carolina, Puerto Rico, and Wisconsin. The drugmaker’s other major production sites include facilities in China, France, Ireland, Italy, Japan, and Spain.

In November, Lilly announced plans to build a $3 billion oral medicine manufacturing facility in the Netherlands. The company said in October that it is investing $1 billion in India to expand contract manufacturing capacity.

Despite its efforts to meet projected worldwide demand with additional internal and contracted manufacturing capacity, Lilly acknowledged in its annual report “there can be no assurances that such capacity increases that we expect will be needed to meet future demand will be realized as expected or that we will meet demand in launched markets in the future.”