Eli Lilly has sent cease-and-desist letters to hundreds of pharmacies, telemedicine companies, and health spas that manufacture and sell “combined” versions of tirzepatide. This hawkish legal strategy signals the beginning of a new phase of the GLP-1 gold rush: a crackdown on any company selling non-name brand drugs.
Tirzepatide, the active ingredient in Eli Lilly’s diabetes drug Munjaro and weight loss drug Zepbound, was on the U.S. Food and Drug Administration’s shortage list from December 2022 to October 2, 2024. When drugs become scarce in the United States, pharmacists, doctors, and licensed outsourcing facilities are allowed to “compound” copies to ensure patients get the medications they need. With so many potential patients eager to take GLP-1 drugs, both tirzepatide and semaglutide (the active ingredients in Ozempic and Wegovy) are in short supply, leaving a huge gap 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 formulators to make their own GLP-1 ducks, and they did so in unprecedented quantities. Leading telemedicine clinics have begun selling these products online at a fraction of the price of name-brand products. There is no clear explanation for how many patients are taking compounded GLP-1 drugs, but Scott Brunner, CEO of the Alliance for Pharmacy Compounding, told WIRED: , said they estimate the number to be in the millions.
This is not the first time Eli Lilly has taken legal action regarding combination tirzepatide. The pharmaceutical giant is facing numerous lawsuits alleging that its distributors deceptively advertised “generic tirzepatide” or “generic mounjaro” and called their combination products “FDA-approved.” It’s happening. (Unlike standard brand-name or generic drugs, compounded drugs are not subject to an FDA approval process before they go to market.) But this is a sign of Lilly’s fight against what it considers counterfeit products. It represents a major escalation.
At least one of the cease and desist letters was addressed to a virtual telemedicine clinic that sells an oral version of tirzepatide, which is sold in pill form rather than as an injectable drug. Eli Lilly specifically accused the oral tirzepatide distributor of “experimenting” on customers, noting that the U.S. Food and Drug Administration has not approved any oral tirzepatide treatments.
Eli Lilly also targeted at least one weight-loss clinic promoting its tirzepatide product on Reddit. Reddit has several active communities dedicated to the formulation of GLP-1 drugs.
As the shortage eased, some telemedicine companies offering the drug encouraged patients to order expanded supplies of the drug in hopes of getting them through the next few months. In at least one cease-and-desist letter, Eli Lilly noted that the clinic had begun offering “extended prescriptions,” which Lilly contends was an “unlawful attempt to avoid shortages.” There is.
The reversal of the tirzepatide shortage has created a difficult situation for many patients taking combined forms of the drug. As WIRED recently reported, many of these patients are concerned about not being able to afford or access name-brand drugs. Eli Lilly recently introduced new, cheaper versions of Mounjaro and Zepbound (which come in vials instead of syringe pens), with monthly prices ranging from $400 to $550 depending on dosage. , which is still considerably more expensive than many products. Combination vials are also available.
