Eli Lilly has filed a motion to participate in a lawsuit concerning compounded versions of its popular weight-loss drugs and diabetes drugs, Zepbound and Mounjaro. The case, brought by compounding pharmacies against the U.S. Food and Drug Administration (FDA), challenges the agency’s decision that these medications are no longer in short supply.

Lilly’s Motion to Protect Its Interests in Weight-Loss Drugs

In a filing submitted to a federal court in Fort Worth, Texas, Eli Lilly expressed concerns that the FDA might not fully defend the company’s interests. The lawsuit’s outcome will determine whether compounding pharmacies and facilities can continue to produce and sell cheaper, non-FDA-approved versions of Zepbound and Mounjaro, which share the active ingredient tirzepatide.

The compounded versions are considered copies of Lilly’s branded drugs and can only be manufactured in significant quantities if a shortage is declared. The FDA, however, decided in October that there was no longer a shortage of tripeptide drugs. After reviewing the decision in December, the agency reaffirmed its position but stated it would delay enforcement for at least 60 days.

Eli Lilly argued in its motion that it needed to join the case to safeguard its interests, as it could not be certain the FDA would appeal if the court ruled against the agency. The company also contended that traditional compounding pharmacies, as opposed to larger outsourcing facilities, should not manufacture compounded drugs even during a shortage. This view may conflict with the FDA’s position.

Ongoing Dispute Over Compounded Drugs

Compounded drugs have become a contentious issue in the pharmaceutical industry. These non-FDA-approved medications are often less expensive than branded drugs, making them appealing to patients who pay out of pocket. However, federal regulations require compounded drugs to meet specific criteria, including being necessary due to a shortage of the original medication.

Novo Nordisk’s weight-loss drug Wegovy, a rival to Lilly’s offerings, remains on the FDA’s shortage list. According to a survey by an industry group, more than 200,000 prescriptions for compounded versions of Wegovy are filled each month.

Lilly’s drugs, Zepbound and Mounjaro, are primarily covered by insurance for diabetes treatment, but coverage for their use as weight-loss medications is limited. This has driven many patients to seek compounded alternatives, which are typically more affordable.

Lilly’s Legal Actions Against Compounded Versions

In August, Lilly took steps to curb the production and sale of compounded versions of its drugs. The company sent cease-and-desist letters to telehealth companies, wellness centers, and medical spas offering these alternatives. It also filed lawsuits against entities falsely claiming to sell FDA-approved versions of the drugs.

Lilly’s legal efforts are part of a broader attempt to protect its intellectual property and maintain control over the market for its medications. The company has emphasized that compounded versions of its drugs may not meet the rigorous standards of safety and efficacy required for FDA approval.

Implications for the Pharmaceutical Industry

The lawsuit highlights the ongoing tension between brand-name pharmaceutical companies, the FDA, and compounding pharmacies. As the demand for weight-loss drugs continues to rise, the availability of cheaper alternatives poses challenges for companies like Lilly and Novo Nordisk.

The case also underscores broader concerns about access to affordable medications. While compounded drugs provide a cost-effective option for many patients, questions about their safety, quality, and legality remain unresolved.

The court’s decision in this case will have significant implications for the pharmaceutical industry, particularly for companies producing high-demand medications like Zepbound, Mounjaro, and Wegovy. It will also shape the regulatory framework governing compounded drugs and their role in addressing patient needs.