Novo struggles once again to allege deception by sellers of compounded drugs

Novo Nordisk v. Zealthy Inc., 2026 WL 2212889, No. 25-cv-06391 (ALC) (S.D.N.Y. Jul. 31, 2026)

Novo Nordisk makes the FDA-approved Ozempic, Rybelsus, and Wegovy, while Zealthy markets and facilitates access to drug products, including compounded medications containing semaglutide. Novo alleged that Zealthy made false representations to consumers that compounded semaglutide medications are “equivalent” to Plaintiffs’ medications, “clinically studied,” “evaluated by the FDA,” and “deemed safe and effective.” Specifically, Zealthy stated that “GLP-1 medications, with active ingredient semaglutide, are FDA-approved for type 2 diabetes and have proven effective for weight loss,” “[m]edications with the active ingredient semaglutide have shown 15-20% average weight loss,” and “semaglutide is the active ingredient in Wegovy and Ozempic,” among other similar messages. This allegedly violated the Lanham Act and NY GBL § 349.

The court found that Novo failed to state a claim.

Lanham Act false advertising: As to FDA approval, Novo argued that Zealthy’s statements about GLP-1 medications being FDA-approved were false in that such statements represent compounded semaglutide products as FDA-approved. But Zealthy also facilitates prescription of Novo’s FDA-approved medications, and so its statements could reasonably describe Novo’s own medications, making them not literally false. Novo failed to allege facts indicating likely deception and thus didn’t properly allege implicit falsity. It also failed to allege deliberate deception, which could lead the court to presume deception.

Clinical efficacy: Novo argued that Zealthy misled consumers by describing semaglutide medications as effective without having conducted any clinical studies on the products. But Novo bore the burden of showing falsity, not lack of substantiation.

Equivalence: Novo pointed to statements that “semaglutide is the active ingredient in Wegovy and Ozempic,” “Zealthy also offers semaglutide, the active ingredient in Ozempic® & Wegovy®,” and “[i]f you were thinking about doing the medication or you were on the medication and insurance doesn’t cover it anymore, this is a great replacement, it’s the same medication, semaglutide, and it works just the same.” But there was no showing of falsity there. Although Novo alleged that compounded medications were manufactured through different processes, and that compounded medications do not have the same “effectiveness assurances” as FDA-approved drugs, that wasn’t enough to allege that the two types of medications do not “work [ ] the same.”

However, Novo would have had standing if it had pled falsity/misleadingness. Indeed, the court would be inclined to presume injury given that the ads drew direct comparisons between Novo’s products and compounded drugs. In addition, claims about FDA approval were not FDCA-preempted because (1) it’s preclusion when it comes to the federal Lanham Act, and (2) the court wouldn’t have to interpret or apply the FDCA to conclude that compounded drugs aren’t FDA-approved. On the other hand, “[e]valuating whether Defendant falsely asserted that compounded medications have shown certain levels of weight loss, and whether such statements could only be made with the backing of clinical trials, may well be precluded by the FDCA.” So too with equivalence.

Given this result, the court declined to address the state law claims.