Novo Nordisk, the maker of blockbuster weight loss drug Wegovy and diabetes treatment Ozempic, scored a major legal victory on Thursday when US District Judge Mark Pittman rejected a bid by compounding pharmacies to keep making copies of the drugs. The decision prevents many compounding pharmacies from marketing or selling cheaper, unapproved versions of Wegovy and Ozempic.
The FDA declared semaglutide, the active ingredient in both drugs, no longer in shortage in February. However, patients flocked to compounded versions of the medication when it was short-supplied due to high demand or lack of insurance coverage.
A federal judge in Texas earlier this week ruled in favor of Novo Nordisk against a 503A pharmacy, permanently prohibiting the business from marketing or selling compounded semaglutide. The decision upholds the FDA’s previous determination that the semaglutide shortage in the US is over and allows the agency to target so-called 503A pharmacies.
Novo Nordisk and Eli Lilly have taken aggressive action against compounding pharmacies, which benefit from the soaring popularity of their weight loss and diabetes drugs. The companies’ actions may lead to product seizures and warning letters for pharmacies that break FDA regulations.
The outcome marks a significant win for Novo Nordisk in its efforts to protect patients from counterfeit medications.
Source: https://www.cnbc.com/2025/04/25/novo-nordisk-legal-win-bars-many-compounded-wegovy-ozempic-drugs.html