Novo Nordisk Sues Hims & Hers as FDA Moves to Restrict Compounded GLP-1 Drugs

Novo Nordisk has escalated its fight against compounded semaglutide products by filing a patent infringement lawsuit against Hims & Hers Health, while the US Food and Drug Administration (FDA) announced sweeping enforcement actions aimed at restricting mass-marketed compounded GLP-1 drugs.

The parallel actions signal a tightening regulatory and legal environment for compounding pharmacies and telehealth companies offering non-FDA-approved alternatives to branded GLP-1 therapies, particularly now that supply shortages have been resolved.

Novo Nordisk Alleges Patent Infringement and Patient Safety Risks

On February 9, 2026, Novo Nordisk announced it had filed suit against Hims & Hers for infringing US Patent No. 8 129 343 through the marketing and sale of compounded semaglutide products in the US market. The company alleges that Hims unlawfully mass markets unapproved versions of Novo’s FDA-approved semaglutide medicines, including Wegovy and Ozempic, deceiving patients and health care professionals and placing patient safety at risk.

According to Novo, Hims engaged in promotional campaigns highlighting the purported benefits and safety of its compounded semaglutide offerings, including its recently launched—and abruptly discontinued—compounded oral GLP-1 pill. The launch followed closely behind Novo’s introduction of the Wegovy pill, the first and only FDA-approved oral GLP-1 medication for weight loss.

Although Hims has stopped offering the compounded pill, Novo alleges the company continues to unlawfully mass compound injectable semaglutide products using inauthentic active pharmaceutical ingredients (API).

Novo is asking the court to permanently bar Hims from selling unapproved compounded drugs that infringe its patents and is seeking monetary damages.

Safety Concerns Central to Novo’s Legal Strategy

Novo Nordisk framed its lawsuit as a patient safety measure, citing internal testing that found compounded semaglutide products contained significant impurities. According to the company, injectable compounded semaglutide products tested contained impurity levels as high as 86%, while compounded oral versions contained impurities of up to 75%.

Novo warned that such impurities may lead to serious adverse outcomes, including immune reactions, hospitalization, severe drug-drug interactions, overdoses, and anaphylactic shock. Even small amounts of impurities, the company stated, can compromise drug safety and efficacy.

John F. Kuckelman, senior vice president and group general counsel at Novo Nordisk, said the company’s action is intended to protect patients from “dangerous and deceptive” knock-off products that evade FDA review and undermine the regulatory framework designed to ensure drug safety and effectiveness.

FDA Targets Mass-Marketed Compounded GLP-1 Products

The FDA reinforced Novo’s position last week, announcing its intent to take decisive steps to restrict GLP-1 APIs used in non-FDA-approved compounded drugs that are being mass-marketed as alternatives to approved therapies.

The agency stated that these products are drugs “for which the FDA cannot verify quality, safety, or efficacy,” and emphasized that it takes potential violations of the Federal Food, Drug, and Cosmetic Act seriously.

In addition to API restrictions, the FDA is intensifying its efforts to curb misleading direct-to-consumer advertising. The agency reiterated that companies may not claim compounded products are generic versions of FDA-approved drugs, contain the same active ingredients, or are clinically proven to deliver the same outcomes.

The FDA warned that entities engaged in manufacturing, distributing, or marketing unapproved compounded GLP-1 drugs that fail to correct violations may face enforcement action without further notice, including seizure and injunction.

Implications for Pharmacy and Compounding Practice

The dispute underscores a pivotal shift in federal oversight of compounded GLP-1 medications. While mass compounding surged during earlier shortages of branded semaglutide products, Novo emphasized that all doses of Wegovy and Ozempic are now fully available nationwide, eliminating the shortage-based justification for broad compounding activity.

As branded manufacturers, federal regulators, and law enforcement agencies align on enforcement, pharmacies and telehealth platforms face increasing legal exposure when compounded products are mass marketed or positioned as substitutes for FDA-approved drugs.

References

Novo Nordisk takes legal action against Hims & Hers to protect patients from unsafe, knock-off Wegovy® and Ozempic®. Novo Nordisk. Press release. Published February 9, 2026. Accessed February 10, 2026. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916493

Makary MA. FDA intends to take action against non-FDA-approved GLP-1 drugs. Press release. Published February 6, 2026. Accessed February 10, 2026. https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs