Frank Vinluan , 2025-04-27 13:35:00
Compounded versions of Novo Nordisk’s Wegovy and Ozempic will need to stop production soon. Lawsuits over these products are ongoing, but a federal court ruling in Texas means that compounding pharmacies can’t keep making their products as the legal process continues.
The April 24 order by U.S. District Court Judge Mark Pittman was sealed. But the decision keeps in place the FDA determination that shortages of the metabolic medicines have resolved. The law permits compounded versions of a branded drug only as long as a branded product is in shortage.
Traditional compounding pharmacies, also known as 503A facilities for the section of the Food, Drug & Cosmetic Act that covers them, must stop making these medicines immediately. These pharmacies are mainly regulated by state pharmacy boards.
Outsourcing facilities, which fall under the 503B section of the code, make larger quantities of compounded product and fall under FDA oversight. When the FDA declared the shortage resolved for semaglutide, the main pharmaceutical ingredient in Wegovy and Ozempic, the agency gave 503B facilities until May 22 to stop making compounded versions. The federal court’s decision leaves the expiration of this grace period intact. After that point, the FDA may take enforcement actions against 503B-regulated companies that continue to make compounded semaglutide products.
The suit challenging the FDA determination was filed by the Outsourcing Facilities Association, which represents 503B facilities. The trade group’s chairman, Lee Rosebush, told Reuters that the association presented additional evidence of an ongoing shortage after the suit was filed but Pittman declined to consider it. Rosebush added that the association believes the data show that a shortage remains.
Novo Nordisk said the FDA’s determination was based on its review of the company’s “stable and growing supply of these important FDA-approved medicines.”
“We are pleased the court has rejected the compounders’ attempts to undermine FDA’s data-based decision that the shortage of Wegovy® and Ozempic® is resolved,” Novo Nordisk’s Steve Benz, corporate vice president, legal and U.S. general counsel, said in a prepared statement.
For much of the past two years, strong demand outstripped the ability of Novo Nordisk to supply both Ozempic and Wegovy, leading to shortages of those products. The Eli Lilly metabolic medicines Mounjaro and Zepbound were also in short supply. Persisting shortages left the door open for compounders to step up to meet the market demand with their versions of the metabolic medicines.
Novo Nordisk and Lilly have been making significant investments in manufacturing capabilities to address demand for their products. While some of that capacity has yet to come online, both pharmaceutical giants have increased their production enough to alleviate the shortages. For tirzepatide, the main pharmaceutical ingredient in the Lilly products, the FDA declared the shortage resolved last December. The FDA declared the semaglutide product shortage resolved in February.
The drugmakers also introduced lower-cost options to better compete against compounders. Last summer, Lilly added obesity drug Zepbound to LillyDirect, its direct-to-patient online platform. Novo Nordisk responded last month with NovoCare, a new online pharmacy that provides Wegovy directly to eligible patients.
Photo: Mykola Velychko, Getty Images
