Semaglutide’s removal from the FDA shortages list sets the stage for more Novo Nordisk lawsuits

Armin Ghiam: ©Hunton Andrews Kurth LLP

Semaglutide, now widely known for its use in weight loss, spent three years on the Food and Drug Administration national shortages list, beginning in 2022. But on Feb. 21, 2025, the FDA announced its intention to remove semaglutide from that list, effectively clearing the way for Novo Nordisk, maker of Ozempic and Wegovy, to pursue additional litigation against pharmacies and clinics that have been making and selling compounded semaglutide.

The FDA originally approved Ozempic as a Type 2 diabetes medication. A few years ago, health care professionals discovered that Ozempic can cause loss of appetite, and patients who took the drug often lost weight. Due to a subsequent sudden spike in demand, the FDA added Ozempic and Wegovy to its national shortages list in 2022.

When an FDA-approved drug is on the shortages list, restrictions do not apply to compounded drugs that are essentially copies of the approved drug. As a result, pharmacies across the U.S. began compounding semaglutide. Soon after, semaglutide fills increased by 442% between January 2021 and December 2023.

Unsurprisingly, Novo Nordisk expressed concern over the rise in compounding, arguing that compounded products are associated with a higher risk of side effects. (It is unclear whether compounding diverted any sales from Novo Nordisk because most patients who took these compounded prescriptions did not qualify for insurance coverage and the price of Ozempic is prohibitively higher than the price of compounded semaglutide.)

Novo Nordisk began filing trademark infringement and false advertising lawsuits against compounding pharmacies and weight loss clinics—over 120 district court litigations in two years. To register a federal trademark for a drug in the U.S. to protect the name, logo, and/or symbol of the drug, one must go through the FDA’s Division of Medication Error Prevention and Analysis (DMEPA). This is to ensure that the name, logo, or symbol is not already trademarked by another company. Additionally, DMEPA must review to make sure the name is not misleading with respect to what the drug is or how it is used.

Hebi Dani:©Hunton Andrews Kurth LLP

Novo Nordisk alleged trademark infringement against clinics using the Ozempic or Wegovy marks and false advertising for claims such as: “semaglutide is FDA-approved,” “compounded semaglutide achieves the same results as Ozempic or Wegovy,” or “compounded semaglutide has the same active ingredient as Ozempic or Wegovy.” Of note: To prevail on false advertising under the Lanham Act, courts have historically required plaintiffs to prove that claims are “literally false or misleading to the public.” Most of the Novo Nordisk cases resulted in quick settlements followed by entry of a consent judgment limiting the defendant’s ability to advertise its compounded product (but not limiting the ability to sell compounded semaglutide).

However, some pharmacies and clinics pushed back, which could test the waters of the Lanham Act, as well as the Federal Food, Drug and Cosmetics (FD&C) Act, in the context of telehealth services, online prescriptions, and compounding. How these cases are decided could be significant for the future of the false advertising claims.

For example, in Novo Nordisk A/S et al. v. Goglia Nutrition, LLC, No. 3:24-cv-01385 (S.D. Cal. Aug 02, 2024), Goglia Nutrition moved to dismiss the litigation. Goglia Nutrition had two separate businesses, G-Plans and Futurhealth. These companies offered both Ozempic and Wegovy, in addition to other compounded semaglutide medications. Users logged onto one of these companies’ websites filled out an intake form and were offered to consult with a physician—or a choice of semaglutide, whether compounded or not—based on their responses. Novo Nordisk alleged trademark infringement and unfair competition based on use of the Ozempic and Wegovy marks. Goglia argued that the court should dismiss Novo Nordik’s claims because Novo Nordisk made improper group allegations between the companies and for failure to state a claim for trademark infringement as a matter of law because Goglia Nutrition’s use of the mark was a nominative use. As of this writing, the court had not decided on Goglia Nutrition’s motion.

The defendant also moved to dismiss in Novo Nordisk A/S et al. v. Rapid Weight Loss and Esthetics Center Inc., No. 4:25-cv-00446 (D.S.C. Jan. 23, 2025). There, Novo Nordisk brought a Lanham Act claim alleging Rapid Weight Loss made false and misleading claims in promoting Ozempic and Wegovy. Rapid Weight Loss argued that the Lanham Act cannot be used to enforce the FD&C Act but that the FDA must enforce it instead. The judge disagreed with the latter argument, and so denied Rapid Weight Loss’s motion.

In Novo Nordisk Inc. v. Brooksville Pharmaceuticals Inc., No. 8:23-cv-01503 (M.D. Fla. Jul. 06, 2023), the court granted defendant Brooksville’s motion for summary judgment as to Novo Nordisk’s Florida Drug and Cosmetic Act (FDCA) and Florida Deceptive and Unfair Trade Practices Act (FDUTPA) claims. Novo Nordisk had claimed Brooksville violated the FDCA by selling adulterated and misbranded drugs and that it also violated FDUTPA because Brooksville’s claimed violation of the FDCA caused it to suffer economic harm. It also reasoned that since none of Brooksville’s thousands of customers were hurt in any way from its semaglutide compound, Novo Nordisk could not prove injury as required under FDUTPA. (And, subsequent to semaglutide’s removal from the FDA’s shortages list, the court found that the case was moot; Brooksville was only producing patient-specific compounds involving semaglutide.) On July 15, Brooksville filed a motion for attorneys’ fees.

After the FDA formally announced its intention to remove semaglutide injection products from the national shortages list, local pharmacies seeking to continue compounding semaglutide immediately challenged the FDA’s order. Then on April 24, 2025, a federal district court denied a preliminary injunction request to prevent the removal of the shortage designation from going into effect. Outsourcing Facilities Association v. FDA, No. 4:25-cv-00174 (N.D. Tex.).

Effective as of April 28, 2025, for 503A pharmacies (pharmacies that compound medications on an individualized basis as described under Section 503A of the FD&C Act, like the ones in the cases above), the FDA removed Ozempic and Wegovy from its national shortages list. Pharmacies are currently allowed to compound semaglutide for an individual patient on the basis of a valid prescription, known as the “personalization” requirement. However, pharmacists cannot compound “regularly or inordinate amounts” of any drug products that are “essentially copies of a commercially available” drug product.

Recently, Novo Nordisk has filed a new wave of lawsuits, including against a pharmacy and eight clinics and telemedicine companies. One suit alleges patent infringement. Others allege Lanham Act violations for trademark infringement and false advertising, generally focused on misappropriation of Ozempic and Wegovy trademarks, FDA approval of semaglutide, and lack of substantiation of advertised results. However, there is also a new claim—for personalization of semaglutide—in which Novo Nordisk alleges that defendants that are internet companies (not pharmacies) are distributing bulk medication from compounding pharmacies.

What’s to come from these new cases is yet to be seen. Again, under the Lanham Act, the burden of proof is with Novo Nordisk to show that an advertisement is false or misleading. This is in stark contrast to claims, e.g., by the Federal Trade Commission or in the National Advertising Division, where the advertiser has the burden to substantiate its statement.

It does not appear that any of Novo Nordisk’s prior or new Lanham Act claims have been tested by summary judgment. Nor does it appear that Novo Nordisk has yet presented any survey or scientific evidence to prove its claims. The complaints we reviewed also do not allege that Novo Nordisk physically tested any of the compounded semaglutide products of a particular defendant before filing a claim against it. This may invite challenges to the sufficiency of the pleadings relative to Federal Rule of Civil Procedure 9’s particularized pleading requirement. Beyond that, Novo Nordisk’s damages claims could face arguments that many patients who used compounded products did not qualify for insurance coverage and thus would not have purchased Ozempic or Wegovy in any event. Additionally, when Ozempic was on the national shortages list, the drug was arguably not available to these patients even if they could afford the medication.

It will be interesting to observe how these cases progress and whether the courts ultimately address the substantive legal issues.

Armin Ghiam is a partner in Hunton Andrews Kurth LLP’s Intellectual Property group in the firm’s New York office. With an international background in law, finance and technology, he counsels clients on litigation, prosecution and transactions involving patents, trademarks, copyrights and trade secrets.

 Dani Heba is a summer associate in Hunton’s New York office.