Lilly sends cease-and-desist letters to providers selling compounded Zepbound and Mounjaro

Eli Lilly has sent cease-and-desist letters to U.S. healthcare providers in recent days, demanding that they stop promoting compounded versions of its weight-loss and diabetes drugs Zepbound and Mounjaro, the company said on August 14, 2024 ^[1]. The letters went to telehealth companies, wellness centers and medical spas selling compounded versions of the drugs, a Lilly spokesperson told Reuters ^[1].

Compounded drugs are custom-made medicines based on the same ingredients as brand-name drugs ^[1]. Mounjaro and Zepbound are both known chemically as tirzepatide ^[1]. Because the two drugs were in short supply, licensed pharmacies in the U.S. could legally produce compounded versions of them ^[1].

Surging demand for Lilly's drugs and for Novo Nordisk's competing weight-loss medicines has prompted many sellers to offer compounded versions at lower prices. A month's supply of the brand-name products can cost more than $1,000 ^[1].

"When FDA-approved medicines are 'commercially available', compounders cannot regularly make 'essentially a copy' of them," Lilly said in an emailed statement to Reuters ^[1].

The letters mark a step beyond the courtroom. Lilly and Novo Nordisk have previously sued more than three dozen medical spas, weight-loss clinics, compounding pharmacies and online sellers in total over products that claim to contain the active ingredients in their drugs ^[1].

The FDA has listed all doses of Lilly's drugs as available but has not removed them from its shortage list ^[1]. The agency said in an emailed response that it is working to determine whether the available supply of tirzepatide would meet its definition of a resolved shortage ^[1].

Regulators have also flagged safety issues with compounded copies of Novo Nordisk's drugs. In July 2024, the FDA warned patients and doctors about dosing errors tied to those products. The agency said it had received reports of adverse events, some requiring hospitalization, that may be related to overdoses when patients incorrectly self-administered the compounded drug or when healthcare providers miscalculated doses ^[1].

Why it matters for patients

Compounded versions of tirzepatide exist largely because of cost and supply. A patient who cannot afford a brand-name medicine that can run above $1,000 a month may have been offered a compounded alternative instead ^[1]. Whether pharmacies may keep making those copies turns on the FDA's shortage determination, which is still unresolved ^[1].

The agency's warning about dosing errors points to a practical difference between the two products: compounded medicines can be prepared in different strengths and forms, and the FDA has linked incorrect self-administration and provider miscalculation to hospitalizations, though in that case for compounded versions of Novo Nordisk's drugs rather than Lilly's ^[1].

It has not been reported how many letters Lilly sent, what response it asked for, or what consequences the company says providers could face. Lilly has not disclosed what it plans to do if providers do not comply.

What happens next

The FDA is still deciding whether the tirzepatide shortage is resolved ^[1]. That decision determines whether compounding pharmacies can keep making copies of Mounjaro and Zepbound on a regular basis. No timeline for that decision has been disclosed ^[1]. Lily has also not said whether it will take further action against providers beyond the letters ^[1].