Eli Lilly has filed lawsuits in several states seeking to prevent unauthorized selling of products that claim to contain tirzepatide, the active ingredient in its blockbuster type 2 diabetes drug Mounjaro.
Pictured: Eli Lilly headquarters in Indianapolis/iStock, jetcityimage
Eli Lilly on Tuesday announced it has taken legal action against U.S. medical spas, wellness centers and compounding pharmacies for selling products with tirzepatide, the active ingredient in its blockbuster drug Mounjaro.
Approved by the FDA to treat type 2 diabetes, Mounjaro is commercially available only through Lilly. The medication is also only available in prefilled single-dose pens.
“Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product. Because of this, Lilly filed lawsuits to protect patient safety and stop the unlawful marketing and sale of non-FDA approved compounded products fraudulently claiming to be Mounjaro (tirzepatide) by medical spas, wellness centers and compounding pharmacies,” the company said in a statement
In four different lawsuits filed in Florida and Texas federal courts, Lilly is seeking to ban Better Life Pharmacy, ReviveRX, Rx Compound Store and Wells Pharmacy Network from selling tirzepatide. The company is also requesting unspecified damages.
Lilly is accusing these compounding pharmacies of violating federal and state consumer production and competition laws by selling unregulated and unapproved versions of Mounjaro.
In addition, Lilly is accusing six medical spas and wellness centers in Arizona, Florida, Georgia, Minnesota, South Carolina and Utah of infringing its trademark by marketing compounded tirzepatide as Mounjaro.
“Defendants use Lilly’s trademark to attract customers and generate revenues and profits, including by passing off as ‘Mounjaro’ their own unapproved compounded drugs purporting to contain tirzepatide, and doing so for a use for which Mounjaro is not approved, namely weight loss,” Lilly said in the lawsuits. “These entities should be stopped from providing drug products in violation of consumer protection laws, particularly where they promise their patients that their drugs offer the same safety profile and clinical benefits as Mounjaro.”
The lawsuits come just two months after rival Novo Nordisk, which markets the popular obesity treatment Wegovy, sued medical spas and compounding pharmacies for selling products that claimed to contain semaglutide. The active compound semaglutide is also found in the company’s best-selling type 2 diabetes drug Ozempic.
The FDA previously reported adverse events in those people who used compounded semaglutide, warning that patients “should not use a compounded drug if an approved drug is available.” These compounded versions do not adhere to the same FDA regulations as fully approved products.
Novo Nordisk filed multiple lawsuits across different federal courts in the U.S. However. Lilly claims to be taking the legal actions not only to protect its own company, but also to protect their patients.
Compounded versions of tirzepatide can contribute to potentially serious health risks, according to Lilly.
“Products claiming to contain tirzepatide that are made and/or distributed by compounding pharmacies or distributed by counterfeit sources have not been reviewed by the U.S. FDA or global regulatory agencies for safety, quality, or efficacy; are not FDA-approved like Mounjaro; and may expose patients to potentially serious health risks,” the company said.
Matt Olszewski is a freelance writer based in Boston. Reach him on LinkedIn.
