Pharma & biotech
Novo Nordisk, Eli Lilly and FDA win appeal over compounded weight-loss drugs
The ruling covers Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound
RITZAU ‎andMARKETWIRE ‎
28 August 2026at 09:20
Novo Nordisk and Eli Lilly, together with the US Food and Drug Administration (FDA), have won a federal appeals court case concerning the availability of compounded versions of the companies’ blockbuster diabetes and obesity drugs
Under US law, pharmacists and specialized compounding pharmacies may prepare customized versions of medications when there is a shortage of the commercially available drug
The FDA has determined that the shortages of Eli Lilly’s Zepbound and Mounjaro and Novo Nordisk’s Wegovy and Ozempic have ended. That decision means compounding pharmacies can no longer rely on drug shortages as a basis for broadly producing copies of the medications
A federal district court in Texas previously upheld the FDA’s decision. The Outsourcing Facilities Association (OFA), which represents compounding pharmacies, challenged the ruling and appealed the case
The appeals court has now ruled that the FDA followed the correct procedures in determining that the drugs were no longer in shortage
“Overall, the FDA made a well-reasoned decision,” the court said in its ruling concerning Eli Lilly’s drugs
Regarding Novo Nordisk, the court concluded that “the FDA’s final decision was neither arbitrary nor unreasonable.”
The ruling is significant for the rapidly expanding market for GLP-1 medications. So-called compounders can mix and customize medicines to meet individual patients’ needs, including when a drug is in short supply. Novo Nordisk’s and Eli Lilly’s drugs had been listed as being in shortage since 2022, creating an opportunity for compounding pharmacies to sell lower-cost, unapproved versions
As a result, millions of Americans are estimated to have used compounded versions of these medications
Increased competition for Novo Nordisk
The availability of compounded versions has increased competition in the weight-loss drug market and contributed to pressure on Novo Nordisk’s outlook
The Danish pharmaceutical company lowered its financial forecasts several times during 2025 and once in 2026. More recently, however, Novo Nordisk has raised its 2026 outlook in connection with its first- and second-quarter earnings reports
The company currently expects adjusted sales growth of between 0% and minus 6% for the year
One factor behind the latest improvement in its outlook was stronger-than-expected demand for GLP-1 medicines
Both Ozempic and Wegovy contain semaglutide, a GLP-1 receptor agonist. These medicines help regulate blood sugar and also influence appetite and feelings of fullness, which can contribute to significant weight loss
The appeals court ruling could therefore remove an importantcompanies continue to face pressure from other competitors in the rapidly developing obesity-drug market
