Eli Lilly Seeks Medical Records from Users of Compounded Versions of Its Weight-Loss Drugs Amid Crackdown

Intelligent Finance APP learned that the U.S. pharmaceutical giant Eli Lilly and Company (LLY.US) recently requested users of its best-selling weight loss drug generic versions to provide their medical records to the company for safety reasons. This move may aim to crack down on companies or pharmacies selling generic versions of compounded weight loss drugs. Some compounding pharmacies utilized a legal provision allowing them to sell generic versions of Eli Lilly's popular weight loss drugs, Zepbound and Mounjaro, amid shortages of the authentic drugs. While Eli Lilly has questioned the quality of these products and some state inspections have revealed concerning practices, these pharmacies have stated that they are complying with the law to help Americans access the medications they need.

"We recently learned that you obtained one of our types of products from a compounding pharmacy," Eli Lilly and Company wrote in a letter. "We would appreciate it if you could fill out the attached form and sign the medical information release authorization so that we can obtain more details about your experience from your treating physician."

A spokesperson for Eli Lilly and Company confirmed the authenticity of the letter and stated that it was part of the company's ongoing efforts to monitor the market and evaluate the safety of its drugs. The spokesperson mentioned that Eli Lilly sometimes reaches out to individuals who have previously been in contact with the company but did not provide further details.

Eli Lilly and its strongest competitor in the weight-loss drug field, Novo Nordisk A/S, have long faced shortages of their weight-loss medications. They have taken a series of actions to crack down on medical spas, private doctors, and some pharmacies that sell or promote generic versions of these drugs. However, many pharmacies and telehealth companies continue to provide these medications, relying on federal laws that permit the compounding of drugs during shortages.

Conflict Between Brands and Generic Drug Manufacturers

Scott Brunner, CEO of the industry trade group Pharmacy Compounding Alliance, said, "I am simply stunned that Eli Lilly is seeking confidential patient medical records to build a proprietary case against therapies that benefit these patients when Eli Lilly's own drugs fail to help them."

This letter is the latest sign of the intensifying battle between brand-name drug manufacturers and companies that produce and sell generic versions. A Wall Street investment firm stated that this compounded generic weight-loss drug could generate up to $1 billion in revenue for pharmacies.

But Eli Lilly CEO Dave Ricks is not backing down from the fight. In an interview, Ricks stated that compounders "use untested, unapproved substances of unknown quality and purity," but did not provide documentation to support these claims. "We are using our legal tools to address this, and we can challenge the prescribing physicians."

The U.S. Food and Drug Administration (FDA) has listed the ongoing shortage of Eli Lilly and Company’s drugs since December 2022. Recently, the drug supply situation has improved somewhat. Ricks stated that he expects these medications to soon officially come out of shortage and believes that the U.S. Food and Drug Administration (FDA) should take more assistance measures to prevent a surge in compounded generic therapies during this period.

Eli Lilly Aims to Capture a Larger Share of the Weight-Loss Drug Market

Eli Lilly is capturing more weight-loss drug market share in various ways within the current "Nor-Lilly" duopoly. In June, the company ran full-page advertisements in several nationwide publications, targeting the booming market: "We are making weight-loss drugs. But we want to ensure that what you're taking is the genuine product," the advertisement stated.

A recent study found that obese patients using Eli Lilly and Company's Mounjaro (active ingredient: Tirzepatide) — a drug for both weight loss and diabetes treatment — experienced significantly greater weight loss compared to patients using Novo Nordisk's Ozempic (active ingredient: Semaglutide), which is also used for weight loss and diabetes treatment.

The aforementioned research is of great significance to the two pharmaceutical giants, "Eli Lilly and Company" and "Novo Nordisk," which have formed a monopoly in the weight-loss drug market. It may prompt more obese patients or those attempting to lose weight through injections to turn to Eli Lilly rather than Novo Nordisk, potentially having a positive impact on Eli Lilly's stock price.

According to Bloomberg Intelligence research data, by 2030, the market size of weight-loss drugs like "Mounjaro" is expected to reach at least $80 billion. Wall Street giant Goldman Sachs is even more optimistic, with a forecast report showing that by 2030, annual sales in the global anti-obesity drug market could grow to around $130 billion, compared to just $6 billion earlier in 2023. The World Obesity Federation (WOF) predicts that by 2035, more than 4 billion people (more than half of the world's population) may suffer from varying degrees of obesity.

Earlier this week, a spokesperson for telemedicine company Noom Inc. said the company had released its own advertisement in response to "Eli Lilly and Company's recent comments on compounded drugs."

Some compounding pharmacies in the U.S. say they use authentic ingredients from legitimate suppliers to make high-quality weight-loss medications and play an important role in providing these drugs when FDA-approved versions are in short supply.