Eli Lilly has despatched cease-and-desist letters to tons of of compounding pharmacies, telehealth firms, and medical spas making and promoting “compounded” variations of tirzepatide. This hawkish authorized technique signifies {that a} new section of the GLP-1 gold rush has begun—a crackdown towards any entity promoting non-name-brand medicines.
Tirzepatide, the lively ingredient in Eli Lilly’s diabetes drug Mounjaro and weight-loss remedy Zepbound, was on the US Meals and Drug Administration’s scarcity record from December 2022 till October 2, 2024. When medication within the US go into scarcity, pharmacists, docs, and licensed outsourcing services are permitted to “compound” copies to verify sufferers have entry to drugs they want. With so many potential sufferers desperate to get on GLP-1 medicines, the scarcity of each tirzepatide and semaglutide (the lively ingredient in Ozempic and Wegovy) left an enormous opening available in the market. Often, pharmaceutical firms producing blockbuster medication don’t have to fret about competitors till their patents expire. However the shortages meant that it was authorized for compounders to provide their very own GLP-1 dupes—which they did, at an unprecedented quantity. Main telehealth clinics jumped in to promote these merchandise on-line at a fraction of the value of their name-brand counterparts. Whereas there isn’t any definitive accounting for what number of sufferers are taking compounded GLP-1 meds, Alliance for Pharmacy Compounding CEO Scott Brunner tells WIRED that he estimates that the quantity is within the thousands and thousands.
This isn’t the primary authorized motion Eli Lilly has taken relating to compounded tirzepatide. The pharmaceutical behemoth has filed various lawsuits alleging misleading promoting from sellers selling “generic tirzepatide” or “generic Mounjaro” and referring to their compounded merchandise as “FDA-approved.” (Not like commonplace name-brand and generic pharmaceutical medication, compounded medication are usually not topic to the FDA’s approval processes earlier than hitting the market.) However this represents a serious escalation of Lilly’s combat towards what it views as knockoffs.
At the very least one of many cease-and-desist letters is to a digital telehealth clinic promoting an oral model of tirzepatide, bought in capsule type somewhat than as an injectable remedy. Eli Lilly particularly accused this oral tirzepatide vendor of “experimenting” on its clients, noting that the US Meals and Drug Administration has not accepted any oral tirzepatide medicines.
Eli Lilly additionally focused a minimum of one weight-loss clinic selling its tirzepatide merchandise on Reddit, which has a number of lively communities dedicated to compounded GLP-1 medicines.
Within the wake of the scarcity ending, some telehealth firms providing the remedy inspired sufferers to order expanded provides of the medication, meant to tide them over for a number of months. In a minimum of one of many cease-and-desist letters, Eli Lilly famous {that a} clinic had began providing “prolonged prescriptions,” a observe Lilly alleges is an “illegal try to bypass the scarcity.”
The top of the tirzepatide scarcity has created a fraught second for a lot of sufferers taking the compounded model of the drug. As WIRED just lately reported, many of those sufferers are involved that they won’t be able to afford or entry the name-brand variations of their remedy. Whereas Eli Lilly just lately launched a brand new, cheaper model of Mounjaro and Zepbound (which is available in a vial as an alternative of an injector pen), the value per 30 days, which ranges from $400 to $550 relying on dosage, continues to be considerably greater than lots of the compounded vials on supply.