Pharmaceutical companies Novo Nordisk and Eli Lilly are engaged in extensive legal battles to protect their GLP-1 receptor agonist drugs, such as semaglutide (marketed as Ozempic and Wegovy) and tirzepatide (marketed as Mounjaro), from unauthorized compounding and distribution. These medications, initially approved for Type 2 diabetes and later for weight loss, have seen a surge in demand, leading to significant revenues and intensified efforts to safeguard their market positions.
In response to the proliferation of compounded versions of their drugs, both companies have initiated numerous lawsuits against compounding pharmacies and telehealth platforms. For instance, in April 2025, Eli Lilly filed lawsuits against Strive Pharmacy and Empower Pharmacy, accusing them of marketing unapproved tirzepatide products and making misleading claims about their safety and effectiveness. ([glp1newsroom.com](https://www.glp1newsroom.com/post/compounded-glp-1s-vs-big-pharma?utm_source=openai)) Similarly, Novo Nordisk has targeted entities like Axtell’s Rite-Value Pharmacy and Link Pharmacy for allegedly selling non-FDA-approved semaglutide products. ([mondaq.com](https://www.mondaq.com/unitedstates/healthcare/1662696/major-update-on-glp-1-litigation-involving-compounding-pharmacies?utm_source=openai))
The legal landscape is further complicated by the U.S. Food and Drug Administration’s (FDA) actions. The FDA had placed semaglutide and tirzepatide on its drug shortage list, allowing compounding pharmacies to produce these drugs to meet demand. However, as manufacturing capacities increased, the FDA removed tirzepatide from the shortage list in October 2024 and semaglutide in 2025. This led to lawsuits from compounding pharmacies challenging the FDA’s decisions. ([lifescienceleader.com](https://www.lifescienceleader.com/doc/navigating-the-glp-litigation-landscape-0001?utm_source=openai))
Regulatory bodies have also intensified scrutiny. In September 2025, the FDA issued over 50 warning letters to companies compounding or manufacturing GLP-1 drugs, cautioning against false and misleading claims about their products being equivalent to FDA-approved drugs. ([wsgr.com](https://www.wsgr.com/print/v2/content/49056643/FDA-Sends-Warning-Letters-to-More-Than-50-GLP-1-Compounders-and-Manufacturers.pdf?utm_source=openai))
These multifaceted legal and regulatory challenges underscore the complexities pharmaceutical companies face in protecting their intellectual property and ensuring patient safety in a rapidly evolving market.