Eli Lilly has sent cease and desist letters to hundreds of compounding pharmacies, telehealth companies and medical spas that manufacture and sell “compounded” versions of tirzepatide. This tough legal strategy signals that a new phase of the GLP-1 gold rush has begun: a crackdown on any entity selling unbranded drugs.
Tirzepatide, the active ingredient in Eli Lilly’s diabetes drug Mounjaro and weight-loss drug Zepbound, was on the U.S. Food and Drug Administration’s shortage list from December 2022 through Oct. 2. 2024. When medications are in short supply in the U.S., pharmacists, physicians, and licensed outsourcing facilities can “make up” copies to ensure patients have access to the medications they need. With so many potential patients eager to take GLP-1 medications, shortages of tirzepatide and semaglutide (the active ingredient in Ozempic and Wegovy) left a large opening in the market. Pharmaceutical companies that produce blockbuster drugs typically don’t have to worry about competition until their patents expire. But the shortage meant it was legal for compounders to produce their own duplicates of GLP-1, which they did, in unprecedented volume. Leading telehealth clinics have jumped into selling these products online at a fraction of the price of their brand-name counterparts. While there is no definitive accounting of how many patients take GLP-1 compounded medications, Alliance for Pharmacy Compounding CEO Scott Brunner tells WIRED he estimates the number is in the millions.
This is not the first legal action Eli Lilly has taken regarding the compounded tirzepatide. The pharmaceutical giant has filed several lawsuits. alleging Deceptive advertising from sellers who promote “generic tirzepatide” or “generic Mounjaro” and refer to their compounded products as “FDA approved.” (Unlike generic and standard brand name drugs, compounded drugs are not subject to FDA approval processes before reaching the market.) But this represents a major escalation in Lilly’s fight against what it sees as knockoffs.
At least one of the cease-and-desist letters is directed to a virtual telehealth clinic that sells an oral version of tirzepatide, which is sold in pill form rather than as an injectable medication. Eli Lilly specifically accused this oral tirzepatide seller of “experimenting” on its customers, noting that the U.S. Food and Drug Administration has not approved any oral tirzepatide medications.
Eli Lilly also targeted at least one weight loss clinic promoting its tirzepatide products on Reddit, which has several active communities dedicated to GLP-1 compound drugs.
Following the end of the shortage, some telehealth companies offering the drug encouraged patients to request expanded supplies of the drugs, with the intention of keeping them afloat for several months. In at least one of the cease-and-desist letters, Eli Lilly noted that a clinic had begun offering “extended prescriptions,” a practice Lilly alleges is an “illegal attempt to circumvent shortages.”
The end of the tirzepatide shortage has created a tense time for many patients taking the compounded version of the drug. As WIRED recently reported, many of these patients are concerned about not being able to afford or access brand-name versions of their medications. While Eli Lilly recently introduced a new, cheaper version of Mounjaro and Zepbound (which comes in a vial instead of an injector), the price per month, which ranges from $400 to $550 depending on dosage, is still significantly higher than that of many of the compound vials on offer.