Tomorrow, September 24, the Seventh Circuit hears oral argument in Eli Lilly and Company v. Robert F. Kennedy, Jr., the case over whether retatrutide is legally a drug or a biologic. We covered the background earlier today. Here is a quick guide to how the ruling could go, and what each outcome would mean for patients.
Three ways the appeal could go
1. The court orders biologic status
This is what Lilly is asking for. Retatrutide would be treated as a biologic, with 12 years of market exclusivity instead of 5. Biologics are excluded from compounding exemptions, so no pharmacy could ever legally compound it.
2. The court sends it back to the FDA
The district court already vacated the FDA’s classification and remanded the question in 2025. The appeals court could leave that in place, which would put the decision back in the FDA’s hands.
3. The court sides with the FDA
Retatrutide would stay classified as a conventional drug, reviewed through a New Drug Application. That would not make it available any sooner: it’s still in Phase 3 trials, with no approved version.
What won’t change tomorrow
Oral argument isn’t a ruling. Appeals courts usually decide weeks or months later. In the meantime, retatrutide is not FDA-approved for any use, and any retatrutide sold online is being sold illegally, whatever the label says.
This article is for informational purposes only and does not constitute medical advice. Peptide therapy should only be pursued under the guidance of a licensed physician.