Novo Nordisk A/S, et al. v. Mai Kaga, MD LLC a/k/a The Kaga Academy of Aesthetic & Concierge Medicine

District Court, D. New Jersey·Decided December 22, 2025·No. 3:25-cv-00267·Unknown

Opinion

NOT FOR PUBLICATION UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

NOVO NORDISK A/S, et al., Plaintiffs, Civil Action No. 25-267 (MAS) (JBD) v. MEMORANDUM OPINION MAI KAGA, MD LLC a/k/a THE KAGA ACADEMY OF AESTHETIC & CONCIERGE MEDICINE, Defendant.

SHIPP, District Judge This matter comes before the Court upon Defendant Mai Kaga, MD LLC a/k/a The Kaga Academy of Aesthetic & Concierge Medicine’s (“Defendant”) Motion to Dismiss (ECF No. 13) Plaintiffs Novo Nordisk A/S and Novo Nordisk Inc.’s (collectively, “Novo Nordisk” or “Plaintiffs”) Complaint (ECF No. 1). Plaintiffs opposed (ECF No. 15), and Defendant replied (ECF No. 16).! The Court has carefully considered the parties’ submissions and reaches its decision without oral argument under Local Civil Rule 78.1(b). For the reasons outlined below, the Court denies Defendant’s Motion to Dismiss. 1. BACKGROUND’ Novo Nordisk is a pharmaceutical company that manufactures three Food and Drug Administration (“FDA”) approved medications for the treatment of diabetes and chronic weight

' The parties further submitted notices of supplemental authority for the Court’s consideration. (See ECF Nos. 17, 18, 19, 20.) * For the purpose of considering the instant motion, the Court accepts all factual allegations in the Complaint as true. See Phillips v. County of Allegheny, 515 F.3d 224, 228 (3d Cir. 2008).

management: (1) Ozempic; (2) Wegovy; and (3) Rybelsus. (Compl. 9 1-2, ECF No. 1.) Each of these drugs is prescription-only and contains semaglutide as its active ingredient. Ud. {ff 2, 30.) Novo Nordisk is currently the only company in the United States that manufactures FDA-approved medications containing semaglutide, and the FDA has not yet authorized any generic versions of semaglutide-based drugs. Ud. 3, 5, 39.) Novo Nordisk is also the only company authorized to identify its FDA-approved semaglutide medicines using the trademarks Ozempic®, Wegovy®, and Rybelsus®. Ud. § 4.) While no generic versions of semaglutide medicines have been approved by the FDA, certain companies have created “compounded drugs” purportedly containing semaglutide as an active ingredient.’ (id. 34-35.) Compounded drugs, however, are not FDA-approved, and are not evaluated by the FDA for their safety, effectiveness, or quality. dd. § 36.) Novo Nordisk alleges that the processes used to produce most semaglutide in compounding is “fundamentally different” than those used to produce semaglutide in Plaintiffs’ FDA-approved medicines. (/d. 439.) For example, while Novo Nordisk produces its medications using yeast cells under a “closely controlled multistep process that uses recombinant DNA technology,” most compounded semaglutide products are manufactured via chemical synthesis. (/d.) Novo Nordisk alleges that the fundamental differences between these processes have resulted in “new impurities, higher levels of known impurities, immunogenicity concerns, and potential stability issues” in tested samples of compounded semaglutide. (/d.) In response to companies that purport to sell products containing

3 Compounding is a process by which a pharmacist or other medical professional alters a medication to meet a patient’s specific needs, for example, by combining or mixing the medication with other ingredients. (Compl. 35.)

semaglutide, the FDA has issued warning letters noting that Ozempic and Wegovy are the only injectable semaglutide products approved for use in the U.S. market.* (id. 4 5.) Defendant is a health clinic that purports to offer a compounded semaglutide medication for weight loss. Ud. {J 16, 45, 51, 57.) Defendant states in its marketing materials that it offers semaglutide, “which is an FDA-approved injection .. . otherwise known as Ozempic, Wegovy, or Rybelsus.” Ud. § 51; see also id. § 57 (“We offer Semaglutide aka Ozempic/Wegovy/Rybelsus with custom weekly dosing.”); see also id. { 49 (“Thankfully, the FDA has approved semaglutide as an acceptable aide when trying to slim down your figure.’’).) Novo Nordisk alleges that Defendant’s representations are false and misleading because there is no generic version of semaglutide that is FDA-approved, and the only three medications containing semaglutide that are FDA-approved are Ozempic, Wegovy, and Rybelsus, each of which possesses a unique safety and efficacy profile. Ud. [9 5, 29, 50, 52.) Novo Nordisk further alleges that Defendant’s false representations “mislead customers” into believing, incorrectly, that the semaglutide product Defendant offers “has been reviewed and approved by the FDA for safety and effectiveness,” and that Defendant’s drugs are equivalent to, or as effective as, Ozempic, Wegovy, and Rybelsus. Ud. {ff 18, 53.) Novo Nordisk brings this action against Defendant, asserting three causes of action: (1) unfair competition and false advertising in violation of Section 43(a)(1)(B) of the

“ The FDA has also issued guidance on its “Concerns with Unapproved GLP-1 Drugs Used for Weight Loss,” which provides that: (1) “compounded drugs are not FDA approved”; (2) use of compounded drugs containing “semaglutide” “can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality”; and (3) “FDA has received reports of adverse events related to compounded versions of semaglutide ... . However, federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to FDA so it is likely that adverse events from compounded versions of these drugs are underreported.” (Compl. ¥ 43.)

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Novo Nordisk A/S, et al. v. Mai Kaga, MD LLC a/k/a The Kaga Academy of Aesthetic & Concierge Medicine (Novo Nordisk A/S, et al. v. Mai Kaga, MD LLC a/k/a The Kaga Academy of Aesthetic & Concierge Medicine) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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