Novo Nordisk asks FDA to block compounded semaglutide copies

Novo Nordisk asked the Food and Drug Administration on Oct. 22, 2024, to place semaglutide on a federal roster of medicines that compounding pharmacies are barred from producing. Ozempic, used for diabetes, and Wegovy, used for weight loss, both contain semaglutide ^[1].

The request came as a petition nominating the ingredient to the FDA's "Demonstrable Difficulties for Compounding" lists. Products on those lists are deemed too complex for compounders to copy safely, and the ban would hold even during a shortage ^[1]. The FDA said it was reviewing the petition and would reply to Novo Nordisk directly. A final decision is still pending ^[1].

Novo Nordisk based its case on the drug's chemistry. "Semaglutide products fit this description due to their inherent complexity and the potential dangers associated with attempting to compound them," the company said ^[1]. It pointed to unknown impurities, incorrect dosage strengths and batches that contained no semaglutide at all ^[1]. "These drugs are inherently complex to compound safely, and the risks they pose to patient safety far outweigh any benefits," Novo Nordisk said, adding that its goal was for patients to get only FDA-approved semaglutide ^[1].

Shortage rules currently work in the other direction. While a brand-name medicine is scarce, compounding pharmacies may prepare copies if they satisfy FDA requirements ^[1]. Semaglutide has cycled in and out of shortage for two years. When the petition was filed, Wegovy's lowest dose was listed as short, while the drug's other doses and Ozempic were available, according to the FDA's shortage database ^[1].

Price has driven many patients to compounded versions. Branded semaglutide costs roughly $1,000 a month before insurance and rebates, and many health plans decline to cover it for weight loss ^[1].

Regulators have raised their own alarms. In August 2024, the FDA said it had received reports of patients overdosing on compounded semaglutide after errors such as injecting the wrong amount. In October 2024, the agency said compounded semaglutide and similar GLP-1 products are unapproved and are not reviewed for safety, effectiveness or quality ^[1].

The petition sits inside a wider legal campaign. Novo Nordisk has brought 50 lawsuits in a year against clinics, compounding pharmacies and manufacturers. Eli Lilly, which sells the tirzepatide drugs Mounjaro and Zepbound, has filed similar cases. Neither company supplies its active ingredient to outside buyers ^[1].

The fight carried into 2026. On Feb. 9, 2026, Novo Nordisk sued the telehealth company Hims & Hers over a compounded semaglutide pill, seeking a permanent injunction and alleging mass compounding. Hims & Hers first called the pill personalized, then pulled it. Health Law Alliance, a law firm, described the case as the first patent infringement suit against semaglutide 503A compounding; the patent involved, U.S. 8,129,343, covers semaglutide compositions using SNAC delivery technology ^[2].

That same year, the FDA referred Hims & Hers to the Department of Justice over possible violations of the Federal Food, Drug and Cosmetic Act, and said it would take "decisive steps" to restrict GLP-1 active pharmaceutical ingredient for compounding, without saying what those steps would be ^[2]. A proposed FDA rule on demonstrably difficult-to-compound drugs — which would block compounding of liposomal formulations like the one in the Hims & Hers pill — has drawn comments questioning the agency's authority and has not been finalized ^[2]. Novo's 25 mg high-dose Wegovy reached the U.S. market in January 2026 ^[2].

Why it matters for patients

A listing on the difficult-to-compound roster would go beyond shortage policy, taking compounded copies off the table regardless of supply. That affects people whose insurance excludes semaglutide or who pay out of pocket ^[1]. The FDA has said it does not check unapproved compounded products for safety, effectiveness or quality, and it has warned about dosing mistakes ^[1]. How far the agency will go in restricting GLP-1 ingredients for compounding has not been disclosed ^[2]. Tirzepatide remains unsettled too: the FDA removed it from the shortage list in October 2024 after more than a year, a trade group representing compounders sued, and the agency said it would reconsider ^[1].

What happens next

The FDA has not ruled on Novo Nordisk's petition ^[1]. The proposed difficult-to-compound rule was still unfinished as of February 2026 ^[2], and the Hims & Hers patent case was pending ^[2]. No timeline for either the petition decision or the rule has been reported ^[1][2].