Health Law Daily Wrap Up, ADVERTISING (FOOD, DRUG & MEDICAL DEVICES)—D. N.J.: Article III, Lanham Act standing conferred in ‘compounded semaglutide’ case, (Feb 4, 2026)

By Jeffrey H. Brochin, J.D.

Allegations of consumer confusion, loss of goodwill, and reputational harm were sufficient to establish injury-in-fact for the purposes of standing.

In an unpublished opinion, a federal district court in New Jersey has denied the motion to dismiss filed by Liferxmd in a lawsuit brought by Novo Nordisk A/S for alleged violations of the Lanham Act and other unfair competition violations. The lawsuit stemmed from Liferxmd’s advertising of their “compounded semaglutide” product as being a generic equivalent to Novo Nordisk’s brand name products Ozempic® and Wegovy®. Although Liferxmd argued that the manufacturer did not have standing to sue due to lack of injury-in-fact, the court disagreed, finding that there was both constitutional and statutory standing to sue. The court concluded that Novo Nordisk had plausibly alleged an injury-in-fact arising from Liferxmd’s advertising claims (Novo Nordisk A/S v. Liferxmd, No. 24-9018 (MAS) (JBD) (D. N.J. Jan. 28, 2026) (unpublished decision)).

No approved generic. Novo Nordisk manufactures three medications to treat diabetes and obesity. Each of the drugs is prescription-only and contains semaglutide as the primary ingredient. To date, the FDA has not approved any generic versions of semaglutide medicines, although certain companies have created “compounded drugs” that purportedly contain semaglutide as an active ingredient. However, compounded drugs are not FDA-approved nor evaluated by the FDA as to safety or effectiveness. As of June 30, 2024, the FDA had catalogued at least 542 adverse events associated with compounded semaglutide, 388 of which were classified as serious due to involving hospitalization or death.

Liferxmd’s advertising. Liferxmd purports to sell compounded semaglutide for weight loss. It stated in its marketing materials that it offers semaglutide that is “FDA-approved and safe to use with supplements [and] medications.” It further referenced Novo Nordisk’s brand name drugs for diabetes treatment and obesity treatment in its advertising.

Novo Nordisk filed suit claiming that the representations were false and misleading because there is no generic version of semaglutide that is FDA-approved and because the advertising falsely equated the compounded semaglutide with Novo Nordisk’s FDA-approved medications. Presently before the court was Liferxmd’s motion to dismiss, which for the reasons cited below, the court denied.

Article III standing. Liferxmd argued that Novo Nordisk lacked both constitutional and statutory standing to sue because of a lack of injury-in-fact. Turning first to the matter of Article III standing, the court found that Novo Nordisk sufficiently alleged that it manufactures and sells the only FDA-approved medicines containing semaglutide, and, that Liferxmd falsely claimed—or implied—that its semaglutide products were generic equivalents. Novo Nordisk further adequately pleaded that Liferxmd’s representations were likely to cause consumer confusion regarding the source, FDA approval status, and authenticity of the Liferxmd products. The court concluded that allegations of consumer confusion, loss of goodwill, and reputational harm were sufficient to plead injury-in-fact and confer Article III standing.

Lanham Act standing. The court also found that the same allegations likewise established Lanham Act standing. The court cited Supreme Court precedent in which it was held that to establish statutory standing under the Lanham Act, the party asserting a false advertising claim must allege “an injury to a commercial interest in reputation or sales” and that such economic or reputational injury must flow from the deception in the advertiser’s advertising.

Here, Novo Nordisk satisfied both requirements, pleading alleged reputational and goodwill injuries arising from Liferxmd’s marketing of its compounded semaglutide products referencing Novo Nordisk’s brand name products in a manner likely to confuse the consumer. Because those allegations fell squarely within the scope of the Lanham Act, they were sufficient at the motion to dismiss stage to satisfy standing.

FDC Act and preemption. Liferxmd also contended that the claims were preempted by the federal Food Drug and Cosmetic Act (FDC Act) because Congress vested exclusive authority in the FDA to investigate and enforce violations of the Act. However, the court pointed out that courts have consistently held that where a party falsely advertises its products as FDA-approved, adjudicating a false advertising claim in that context does not encroach upon FDA jurisdiction. Here, Novo Nordisk did not seek to litigate the safety or effectiveness of Liferxmd’s semaglutide products, rather only the false and misleading marketing.

Based on the foregoing, the court denied Liferxmd’s motion to dismiss.

The case is No. 24-9018 (MAS) (JBD).

Judge: Shipp, M.

Attorneys: J. Brugh Lower (Gibbons PC) for Novo Nordisk A/S and Novo Nordisk Inc. Armin Ghiam (Hunton Andrews Kurth LLP) for LifeRx.md, Inc.

Companies: Novo Nordisk A/S; Novo Nordisk Inc.; LifeRx.md, Inc.

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