LLY · 10-Q · 2026Q2 · Full report
Supply chain / counterfeit risk
ELI LILLY & Co · 2026-08-05 · Importance 29 · Surprise 24 · In source text
Lilly continues to observe production, marketing, and sale of counterfeit, misbranded, adulterated, and mass-compounded incretin medicines. The company said these practices may create patient-safety risks and undermine the regulatory approval process. Although the FDA confirmed in late 2024 that the prior tirzepatide shortage had ended and required compounding pharmacies to stop mass production, Lilly cannot guarantee compliance and may pursue litigation against unlawful practices.
Key facts
- Company continues to see production, marketing, and sale of counterfeit, misbranded, adulterated, and mass-compounded incretins and will consider all options including filing lawsuits to address unlawful practices. source
- The FDA confirmed in late 2024 that the previous shortage of tirzepatide had ended and that compounding pharmacies are required to cease mass production. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| operating_income | negative | contingent | — | Company continues to see production, marketing, and sale of counterfeit, misbranded, adulterated, and mass-compounded incretins and will… |