Novo Nordisk sues 12 compounding defendants over compounded semaglutide

Novo Nordisk filed lawsuits against 12 compounding defendants on August 4, 2025, expanding its civil campaign against compounded semaglutide. The filings are the latest step in a push that reached more than 130 lawsuits across 40 states by mid-2025, aimed at telehealth companies, compounding pharmacies, medical spas and others selling compounded versions of the drug ^[1].

The suits allege violations of federal compounding rules under Sections 503A and 503B of the Food, Drug, and Cosmetic Act, along with trademark infringement, false advertising and unfair competition. Novo Nordisk has obtained permanent injunctions against numerous defendants, barring them from future violations ^[1]. Eli Lilly has filed similar lawsuits over tirzepatide, sold as Mounjaro and Zepbound ^[1].

The legal shift behind the filings

Semaglutide is the active ingredient in Ozempic and Wegovy. FDA removed semaglutide from its drug shortage list in February 2025 after finding that supplies of the brand-name products met or exceeded nationwide demand ^[1]. Courts in the Northern District of Texas denied attempts to reverse that shortage decision in April and June 2025 and dismissed the case with prejudice ^[1].

Federal law bars compounding a drug that is "essentially a copy" of a commercially available product. FDA weighs four factors: same active ingredient, same route of administration (subcutaneous injection), same dosage form (injectable solution) and same strength, including approved doses from 0.25 mg to 2.4 mg ^[1]. FDA has said it does not intend to take action against a compounder that fills four or fewer prescriptions for the relevant compounded product in a calendar month ^[1].

Novo Nordisk and Eli Lilly also send cease-and-desist letters to compounding pharmacies, weight-loss clinics, medical spas and prescribing physicians. Recipients are typically given 10 to 14 days to respond in writing and certify that they have stopped the conduct. According to the letters, failure to comply will bring civil litigation and referral to regulators ^[1].

Why it matters for patients

Patients who get compounded semaglutide or tirzepatide through a telehealth company, med spa or compounding pharmacy may see that supply end, either because a supplier is sued or stops selling. Under federal compounding law as described in this litigation, cost is not recognized as a medical necessity, so a lower price by itself does not make a compounded copy legal ^[1]. Compounded copies may be treated as adulterated or misbranded, and clinics that order them can be held responsible even if they are not the one doing the compounding ^[1].

Eighteen state boards of pharmacy and medicine have issued alerts to licensees about compounded GLP-1 drugs. Louisiana's Board of Pharmacy imposed restrictions on semaglutide compounding, and Alabama's Board of Medical Examiners issued declaratory rulings ^[1]. FDA-approved semaglutide and tirzepatide products remain on the market, and prescribing decisions about switching products are between patients and their prescribers.

What happens next

On February 6, 2026, FDA said it intends to use "all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns." The agency warned that failure to adequately address violations "may result in legal action without further notice, including, without limitation, seizure and injunction," which could bypass the usual warning-letter process ^[1].

On February 8, Novo Nordisk announced legal action against telehealth company Hims & Hers, asking a court to permanently ban it from selling unapproved compounded drugs ^[1]. Investigations by state boards are underway in multiple states ^[1]. The outcomes of the August 2025 filings against the 12 compounding defendants have not been disclosed.