Eli Lilly sues med spas and compounders over copycat tirzepatide

Eli Lilly filed lawsuits in September 2023 against 10 medical spas, wellness centers and compounding pharmacies, accusing them of selling products marketed as Mounjaro, the company's tirzepatide drug for type 2 diabetes ^[1]. The move mirrored an earlier legal campaign by rival drugmaker Novo Nordisk, which has separately sued compounders over unauthorized versions of its semaglutide products, Ozempic and Wegovy ^[1].

The lawsuits came as demand for GLP-1 drugs has outpaced what Lilly and Novo Nordisk can supply, creating an opening for outside sellers to offer copycat or compounded versions of the medications ^[1]. Novo Nordisk sued two compounders in Florida in November 2023, following its broader push against unauthorized sellers ^[1]. In October 2023, health officials in the United Kingdom and Europe separately warned about falsified Ozempic pens circulating in those markets ^[1].

The problem has not been limited to compounded products sold outside normal pharmacy channels. In December 2023, the FDA and Novo Nordisk warned that counterfeit Ozempic had turned up even in the "legitimate" U.S. drug supply chain ^[1]. Regulators flagged a specific batch, identified by lot number NAR0074 and serial number 430834149057, in a 1 mg injectable dose ^[1]. Thousands of units from that batch were seized, but officials said some may still be in circulation ^[1]. Five people who used products from the lot reported side effects, though the FDA said those effects — nausea, diarrhea and vomiting — were consistent with known Ozempic side effects rather than anything new ^[1]. Novo Nordisk said it could not confirm whether the drug itself was fake, but said visual inspection showed the needles and packaging appeared to be counterfeit ^[1].

The scale of demand driving this activity is large. In the third quarter of 2023, Lilly and Novo Nordisk posted the biggest year-over-year revenue increases in the pharmaceutical industry, at 38% and 29% respectively ^[1]. Ozempic and Wegovy together brought in $4.7 billion in sales that quarter, accounting for 57% of Novo Nordisk's total revenue, while Mounjaro sales reached $1.4 billion ^[1].

Why it matters for patients

Patients using tirzepatide or semaglutide products bought from sources outside a standard pharmacy — including some med spas, wellness centers, or online sellers — may not know exactly what is in the product they are injecting. Lilly's and Novo Nordisk's lawsuits target sellers the companies say used their brand names or active ingredient without authorization, but the sources here do not detail what these specific products actually contained.

The FDA's separate warning about counterfeit Ozempic shows that fake or altered products can appear even through channels that look legitimate, not just through obviously informal sellers ^[1]. Counterfeit needles in particular raise infection risk, according to the FDA and Novo Nordisk ^[1]. It is not yet known from these sources how widespread counterfeit or unauthorized tirzepatide products are compared with semaglutide, or what specific safety problems, if any, have been tied to the products named in Lilly's September lawsuits.

What happens next

As of the sources reviewed, the outcomes of Lilly's September 2023 lawsuits against the 10 med spas, wellness centers and compounders are not detailed. Novo Nordisk's legal actions continued into November 2023 with new lawsuits against Florida compounders, and the FDA's warning about counterfeit Ozempic in the legitimate supply chain was issued in December 2023 ^[1]. Whether similar counterfeit findings will emerge for tirzepatide products, and how enforcement against unauthorized sellers will proceed, is not addressed in the available sources.