Novo Nordisk Wins Legal Battle, Restricts Generic Versions of Wegovy and Ozempic

Novo Nordisk has secured a significant legal victory that substantially restricts compounding pharmacies from marketing or selling cheaper, unapproved generic versions of its popular weight loss drug Wegovy and diabetes treatment Ozempic.

On Thursday evening, a federal judge in Texas rejected a request from compounding pharmacies that sought to continue producing generic versions of Ozempic and Wegovy while legal challenges to the drug shortages were still underway. This ruling responds to a lawsuit filed in February by a compounding pharmacy industry organization against the U.S. Food and Drug Administration (FDA). The FDA had determined that the active ingredient in these drugs, semaglutide, was no longer in short supply in the U.S.

Over the past two years, Ozempic and Wegovy have faced supply shortages due to surging demand. Some patients, unable to afford the expensive treatments or lacking insurance coverage, turned to cheaper generic alternatives. During the FDA's declared shortage, pharmacists were legally allowed to compound generic versions of branded drugs. Several telemedicine companies, including Hims & Hers, also offered these compounded drugs. However, pharmaceutical companies and some health experts have opposed this practice, as the FDA does not approve compounded drugs, which are essentially custom-made generics prescribed by doctors to meet specific patient needs.

Steve Benz, Novo Nordisk's enterprise vice president and chief legal counsel for the U.S., stated, "We are pleased that the court has rejected the compounders' attempt to undermine the FDA's data-driven decision that the semaglutide shortage has been resolved." He further emphasized, "Patient safety remains Novo Nordisk's top priority, and our nationwide legal actions, aimed at protecting Americans from the health risks posed by illegal 'semaglutide' drugs, are proving effective." Benz mentioned over 100 lawsuits filed by the company against compounding pharmacies and other entities in 32 states.

On Thursday, U.S. District Judge Mark Pittman explicitly denied the Outsourcing Facilities Association's request for a preliminary injunction, which aimed to prevent the FDA from taking action against its members producing semaglutide generics. This decision upholds the FDA's previous determination that the semaglutide shortage in the U.S. has ended, allowing the FDA to immediately hold accountable 503A pharmacies that compound semaglutide generics based on individual patient prescriptions. These pharmacies are primarily regulated by individual states rather than the FDA.

This ruling also means the FDA can start taking action against 503B pharmacies, which produce compounded drugs in bulk regardless of prescriptions, after May 22. The FDA's actions can include seizing products and issuing warning letters to pharmacies.

Prior to Thursday's ruling, Novo Nordisk had already secured another victory. Earlier this week, another federal judge in Texas issued a permanent injunction against MediOak Pharmacy, a 503A pharmacy, prohibiting it from marketing or selling compounded semaglutide.

Over the past two years, both Novo Nordisk and Eli Lilly have aggressively targeted compounding pharmacies, benefiting from the popularity of their weight loss and diabetes drugs. Eli Lilly has undergone similar legal processes for its weight loss drug Zepbound and diabetes treatment Mounjaro, which contain the active ingredient tirzepatide. The FDA declared the U.S. shortage of tirzepatide resolved last year, prompting the same compounding pharmacy industry organization to sue the FDA over the drug.

In March, a federal judge rejected the compounding pharmacy industry organization's request for a preliminary injunction against the FDA's enforcement actions regarding the production of Mounjaro and Zepbound generics by its members. The organization has since filed an appeal.