Eli Lilly and Novo Nordisk are aggressively combating the proliferation of copycat versions of their GLP-1 weight-loss and diabetes drugs, such as tirzepatide (Lilly) and semaglutide (Novo Nordisk). These companies have filed numerous federal lawsuits and, more recently, initiated challenges with the BBB National Programs' National Advertising Division (NAD), a self-regulatory body that resolves advertising disputes. Over the past year, they have filed 10 cases with the NAD against compounding pharmacies and telehealth companies, leading to some disputed claims being voluntarily discontinued or modified. This marks an additional front in their comprehensive legal strategy, which also includes cease-and-desist letters and 130 federal lawsuits filed by Novo Nordisk alone.
The stakes are high for both pharmaceutical companies, as their GLP-1 drugs are major revenue generators; Lilly's franchise achieved $40 billion in sales, and Novo's products generated $35 billion last year. The surge in these challenges largely follows an FDA determination that branded GLP-1s are now readily available, thereby restricting the mass production of cheaper, compounded versions that had been utilized by at least $1 million patients during shortage periods. Although compounded drug advertisements are subject to federal laws regarding truthfulness, they do not undergo the same rigorous government approval process as brand-name treatments. However, the FDA has been increasingly active, issuing over 100 warning letters regarding misbranded claims in the past year.
Lilly is also specifically targeting unapproved versions of its experimental weight-loss drug, retatrutide, which has not yet received FDA approval. Despite its unapproved status, a black market for retatrutide has emerged due to promising clinical trial results. Lilly has filed lawsuits against six companies—including compounding pharmacies, medical spas, and online sellers—accusing them of selling illegal versions of retatrutide, often under the guise of "research-use only." These lawsuits, targeting entities like Astra Peptides and Aesthetic Envy, claim that these products endanger consumers with unvetted substances and threaten Lilly's future market by potentially associating negative reactions with its authentic drug.
The company has also reported over 200 entities engaged in this illegal market to various regulatory and law enforcement agencies and identified more than 14,000 instances of illegal retatrutide offerings across websites and social media in over 100 countries. This concerted effort by Lilly follows previous lawsuits against companies selling compounded Mounjaro in 2023. Novo Nordisk has also taken action against companies like Hims & Hers, alleging patent infringement for selling copycat weight-loss drugs, leading to Hims & Hers ceasing the sale of the contested weight-loss pill. Both companies face competitive pressures and pricing challenges, with Novo Nordisk recently experiencing a share price drop and warning of potential net sales declines. Analysts expect retatrutide to be a blockbuster once approved, highlighting the urgency of these protective measures against the illicit market.
