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Eli Lilly files trade complaint to block weight-loss drug knock-offs

Eli Lilly files trade complaint to block weight-loss drug knock-offs
Mounjaro injection pen. (Photo: Sandy Huffaker/The Washington Post/Getty Images)

The pharmaceutical manufacturer filed a complaint with the US International Trade Commission against companies around the world that it alleges are importing, selling and distributing unapproved versions of Mounjaro, its blockbuster drug for diabetes that’s often used for weight loss.

Lilly is targeting foreign importers and domestic distributors that are unlawfully marketing and selling products labelled as Mounjaro, also known as tirzepatide, according to the complaint filed on Thursday. In some cases, the knock-offs have been found to contain impurities, the company alleged. 

The US Food and Drug Administration “does not review the products these companies are importing or distributing for safety, quality, or efficacy — nor does any other global regulatory agency”, Lilly spokesperson Molly McCully said in an email. 

Soaring demand for the drug and others in the GLP-1 class has led to supply shortages for Mounjaro as well as Novo Nordisk A/S’s Ozempic and Wegovy — a void that’s allowed opportunists to step in. While Novo has taken similar legal action to block copies of its drugs, a judge granted a motion to dismiss the complaint earlier this month. Lilly also filed a series of lawsuits against medical spas, wellness centres and compounding pharmacies last month alleging trademark violations and sales of unapproved versions of its drug. 

GLP-1 drugs that suppress appetite and help people lose weight have already been seen leading to disruptions across the consumer and health-care markets. Goldman Sachs Group analysts predicted earlier this week that the market for obesity drugs could reach $100-billion by 2030.   

Some health businesses are marketing access to Mounjaro for weight-loss even though regulators haven’t cleared it for that use, according to the suit filed on Thursday. Lilly expects the drug to gain US market clearance for obesity this year.

The complaint reveals how far-reaching the market for off-brand weight-loss drugs has become. Several of the businesses listed in it are based in China or Hong Kong, but have addresses in the US. Other businesses cited are based in the US, UK, Spain and Poland.

The Washington-based commission is a federal agency whose functions include adjudication of trade disputes.

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