Novo Nordisk wins two Texas rulings against compounded semaglutide sellers
Two Texas court rulings uphold the FDA's finding that the Wegovy and Ozempic shortage is over and permanently bar one compounding pharmacy from selling compounded semaglutide.
Novo Nordisk said on April 25, 2025 that two federal courts in Texas had ruled in its favor in cases involving compounded versions of its semaglutide medicines, Ozempic and Wegovy. One ruling left standing the FDA's decision that the shortage of those injectable drugs is over. The other permanently prohibits a compounding pharmacy from marketing or selling compounded "semaglutide" [1].
The first ruling came a day before the announcement, when a Texas federal court denied a compounding trade association's motion to freeze the FDA's determination that Wegovy and Ozempic are fully available nationwide, and that Novo Nordisk's supply is meeting or exceeding current and projected demand [1]. With the shortage resolved, Novo Nordisk says it is illegal under U.S. compounding law to make or sell knockoff "semaglutide" drugs, with rare exceptions [1].
The company said the FDA may now immediately act against 503A pharmacies compounding those products, and that the grace period for 503B outsourcing facilities to compound semaglutide injectables expires on May 22, 2025 [1].
The second ruling came from the U.S. District Court for the Southern District of Texas, which entered a final judgment and permanent injunction against MediOak Pharmacy LLC, described in the announcement as a 503A pharmacy. The order permanently bars the company from marketing or selling compounded "semaglutide" knockoff drugs [1]. The announcement did not disclose a dollar amount in that case.
"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," said Steve Benz, Novo Nordisk's Corporate Vice President, Legal and US General Counsel [1].
Novo Nordisk says it has filed 111 lawsuits in federal courts across 32 states against entities it accuses of unlawfully marketing and selling compounded "semaglutide," including drugs the company says had impurity levels as high as 33% or were misbranded with inaccurate strength labels [1]. The company pointed to earlier outcomes: an $8.5 million default judgment in Delaware against a business it said falsely claimed its compounded drug was equivalent to Ozempic, and a permanent prohibition against a Tennessee compounding pharmacy, Midtown Express, that Novo Nordisk sued for selling a drug that contained no semaglutide at all [1]. In another case, the announcement says, a court entered a default judgment against an online marketer selling compounded "semaglutide" directly to consumers without a prescription, labeled as for "Research Use Only" [1].
The announcement also cites a Brookings Institution report on imported synthetic semaglutide ingredients. According to that description, three Chinese firms accounted for 20% of the reported quantity of semaglutide imported into the U.S. between March 2023 and September 2024 and had never been inspected by the FDA as of September 2024. Another three Chinese firms, responsible for nearly 45% of reported imported volume over that 18-month period, were cited for current good manufacturing practice violations at their latest FDA inspection [1]. Novo Nordisk says it does not distribute the semaglutide ingredient used in its FDA-approved medicines to any entity for compounding [1].
Separately, the announcement notes that 38 state Attorneys General have called on the FDA to act against compounding pharmacies, that Ohio's Attorney General sent letters to 14 entities, and that Illinois' Attorney General issued cease-and-desist letters in December 2024 to five Chicago-area med spas [1]. It also references an FBI public warning about compounded weight-loss drugs, including mixtures that do not contain semaglutide and drugs with high impurity levels [1].
Why it matters for patients
The legal space for compounded semaglutide injectables has narrowed. The FDA's shortage resolution, left in place by the Texas court, is the trigger: once an FDA-approved drug is deemed available, compounded copies are generally not permitted, with rare exceptions the announcement does not spell out [1].
The safety concerns cited in the announcement are specific: impurity levels as high as 33%, mislabeled strengths, a product that contained no semaglutide at all, and imported ingredients from firms the announcement says lack FDA inspection or had manufacturing violations [1].
What is not addressed: the announcement does not say whether patients currently receiving compounded semaglutide injections can continue, what they should do next, or how much FDA-approved Ozempic or Wegovy costs. It also does not address insurance coverage, and it does not give the terms of the MediOak injunction beyond the marketing and sales prohibition [1].
What happens next
May 22, 2025 is the date Novo Nordisk gives for the end of the grace period for 503B outsourcing facilities to compound semaglutide injectables [1]. The company says it will keep pursuing its lawsuits and "escalate our efforts as necessary" [1]. No rulings beyond those described have been announced.
Each claim in this story comes from Novo Nordisk's own announcement of the rulings, which describes the court decisions and the FDA's shortage determination from the company's perspective [1].
Sources
Semaglutides.org provides information only, not medical advice. Talk to a licensed provider about your own care before making changes. Some telehealth links are affiliate links and are labeled where they appear.