Eli Lilly sues 10 med spas and compounders over copycat tirzepatide
Lilly's suits against sellers of products claimed to be Mounjaro are part of a wider crackdown as counterfeit and compounded versions of these drugs reach U.S. patients.
Eli Lilly sued 10 U.S. medical spas, wellness centers and compounding pharmacies in September, saying they sold products they claimed were its diabetes drug Mounjaro [1]. The cases are part of a broader push by the makers of these drugs against sellers of unapproved versions [1].
Novo Nordisk, which makes the semaglutide products Ozempic and Wegovy, has taken similar action. The company sued two compounding pharmacies in Florida in November [1]. In October, health officials in the United Kingdom and Europe warned about falsified Ozempic pens [1].
Fake versions of these treatments have been uncovered, along with compounded versions that contain unauthorized ingredients [1]. In December, the FDA and Novo warned that counterfeit versions of Ozempic had been found in the legitimate U.S. supply chain [1]. The agency told distributors, pharmacies, health care professionals and patients not to use products labeled with lot number NAR0074 or serial number 430834149057. The fakes come in a 1 mg injected dose. Thousands of units have been seized, but some may still be in circulation, the FDA said [1].
Five people who used products from that lot reported adverse effects, though none were different from Ozempic's known side effects, which include nausea, diarrhea and vomiting [1]. Novo said it is uncertain whether all products from the lot are counterfeit [1].
"Novo Nordisk cannot guarantee the quality or safety of the counterfeit Ozempic product," the company said. "Visual analysis shows that needles and cartons appear to be counterfeit. Product composition has not been conclusively determined" [1]. The FDA and Novo also warned that counterfeit needles could raise the risk of infection [1].
Demand for these drugs has driven sharp sales growth. In the third quarter, Ozempic and Wegovy combined for $4.7 billion in sales, or 57% of Novo's revenue, while Mounjaro sales reached $1.4 billion [1]. Lilly and Novo posted the largest year-over-year revenue increases in the industry, at 38% and 29% respectively [1].
Why it matters for patients
FDA-approved versions of these drugs are made under federal oversight and go through review before they are sold. Compounded and counterfeit products found in the market are not the same thing [1].
In the counterfeit Ozempic case, Novo said it could not guarantee the product's quality or safety and that its composition had not been conclusively determined [1]. Counterfeit needles carry an added risk of infection, according to the FDA and Novo [1]. That means what is inside a pen or vial sold outside the normal supply chain may be unknown.
The FDA's warning gives specific identifiers — lot number NAR0074 and serial number 430834149057 — that let people compare a product against the known counterfeit lot [1]. The names of the 10 businesses Lilly sued, the courts where the cases were filed, the specific legal claims and any outcomes have not been reported. It also has not been reported whether testing confirmed that any product sold by those businesses contained tirzepatide [1].
What happens next
No hearing dates, rulings or settlements in Lilly's lawsuits against the 10 businesses have been disclosed [1]. The FDA's work to trace the counterfeit Ozempic lot, and whether more counterfeit units remain in circulation, has not been resolved publicly [1].
Sources
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