Pharmaceutical giants Novo Nordisk and Eli Lilly are intensifying their litigation strategies to safeguard their GLP-1 drugs, tirzepatide (Mounjaro^®) and semaglutide (Ozempic^®, Wegovy^®). 

On August 4, 2025, Novo Nordisk filed lawsuits against 12 defendants, including several pharmacies. This recent round of litigation marks a strategic shift, as pharmacies have not been the primary target of Novo Nordisk’s legal actions in the past. For example, Novo Nordisk sued Axtell’s Rite-Value Pharmacy, Inc., alleging that they market and sell non-FDA approved injectable drugs claiming to contain semaglutide, in violation of numerous state laws. Similarly, Novo Nordisk also sued Link Pharmacy LLC for its “unlawful, false, and misleading business practices” regarding the marketing and sale of non-FDA approved drugs that claim to contain semaglutide. In both complaints, Novo Nordisk alleged that the pharmacies did not tailor the drugs to patient needs, rendering them essentially copies of Novo Nordisk’s commercially available products. 

In a related development, on July 25, 2025, Eli Lilly and Company (Eli Lilly) filed a lawsuit against Empower Clinic Services, LLC (Empower) in the Southern District of Texas. Empower, a 503A compounding pharmacy and 503B outsourcing facility, is accused by Eli Lilly of “unlawfully manufactur[ing] and s[elling] untested, unapproved weight loss drugs on a large scale,” violating various state consumer protection and deceptive trade practice laws, as well as the Lanham Act. Eli Lilly filed a similar lawsuit against Empower in the District of New Jersey in April 2025, alleging that Empower engaged in a “nationwide scheme to sell its untested products by misleading consumers about their safety and efficacy,” violating the New Jersey Consumer Fraud Act and the Lanham Act. The New Jersey case was part of a series of lawsuits by Eli Lilly involving tirzepatide, following the Outsourcing Facilities Association v. FDA decision that limited 503A and 503B compounders' ability to compound tirzepatide. Eli Lilly voluntarily dismissed the New Jersey case the same day it filed in the Southern District of Texas. This strategic shift may aim to consolidate claims and strengthen Eli Lilly's position against Empower, possibly seeking what it believes could be a more favorable venue in Texas. Notably, FDA issued a warning letter to Empower’s Texas facility in April, which Eli Lilly may attempt to leverage to argue that Empower’s compounded products are unsafe.

As Buchanan previously reported, Novo Nordisk and Eli Lilly have adopted aggressive legal strategies regarding their GLP-1s. These ongoing lawsuits share similar implications as outlined below.

Implications of the Lawsuits on Compounding Pharmacy Practices

The outcome of these lawsuits could significantly impact the compounding pharmacy industry by challenging the boundaries of compounding practices. If Eli Lilly and Novo Nordisk prevail, it could set a precedent that has chilling effects and limits 503A compounders' ability to create formulations resembling commercially available products, potentially leading to stricter regulations and oversight. This could stifle the compounding pharmacy industry, reducing patient options for personalized medications and hindering access to necessary therapies.  Conversely, if compounders successfully defend against these claims, it may reinforce the rights of compounding pharmacies to operate within the applicable regulatory framework and provide tailored medications to patients. Such a ruling would emphasize the importance of maintaining patient access to compounded drugs, particularly for those with unique medical needs that cannot be met by standard formulations.

FDA’s Position on Compounded GLP-1s 

FDA initially removed tirzepatide from the drug shortage list in October 2024; however, this decision was remanded to the Agency for reevaluation due to the Outsourcing Facilities Association lawsuit. In December 2024, the FDA again determined that the drug shortage had been resolved. FDA also removed semaglutide from the drug shortage list in February 2025. Once a drug is no longer in shortage, compounders cannot freely manufacture such products in a manner that might be considered “essentially copies” of that product. Although FDA previously exercised enforcement discretion to avoid disruptions in patient treatment, those periods have now ended. As a result, compounders of tirzepatide and semaglutide face risks not only from litigation by NDA holders but also from FDA enforcement actions.

Additionally, FDA recently published a webpage titled “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss,” which acknowledges that compounded drugs may be appropriate when a patient’s medical need cannot be met by an FDA-approved drug. However, the page also highlights the risks associated with compounded drugs and the potential for adverse events, noting that FDA does not review compounded drugs for safety, effectiveness, or quality before they are marketed.

FDA’s concerns suggest that the Agency may begin regulating compounders of GLP-1s more strictly. Consequently, compounding pharmacies may face significant challenges in meeting patient needs while adhering to FDA regulations. Additionally, the outcome of the ongoing litigation against compounders could further influence FDA policies and enforcement practices, potentially reshaping the landscape for compounding pharmacies and compounded drugs and impacting patient access to essential therapies. 

Conclusion

This legal battle marks a critical juncture for the pharmaceutical and compounding pharmacy industries. The implications of these cases could extend beyond the immediate parties involved. For 503A pharmacies, the outcome could significantly shape the future of compounding practices and the legal and regulatory landscape in which they operate.

As these cases unfold, Buchanan’s FDA team will closely monitor all developments. The resolution of these lawsuits may ultimately redefine the relationship between large pharmaceutical companies and compounding pharmacies, influencing how personalized medications are accessed and delivered to patients nationwide.Buchanan’s team of experienced FDA and pharmacy attorneys is at the forefront of advising compounders on the legal and regulatory framework, as well as opportunities and limitations surrounding the compounding of GLP-1 products. We provide strategic guidance on navigating complex FDA guidance, state board of pharmacy rules and regulations, and other evolving state-level policies to ensure compliance and mitigate risk.