*Martha M. Rumore, PharmD, JD, MS, LLM, FAPhA is Of Counsel at Health Law Alliance and a registered U.S. Patent Attorney.

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On February 9, 2026 Novo Nordisk filed a patent infringement lawsuit against the online telehealth company Hims & Hers for offering compounded semaglutide in pill form. Novo’s 25 mg high-dose Wegovy® product entered the U.S. market in January. Hims & Hers initially asserted its compounded pill is personalized but then abruptly pulled its compounded semaglutide pill offering. Novo is seeking a permanent injunction and asserts mass compounding is occurring and its patents are being infringed. This attack on 503A compounding is two-prong with yet another significant FDA re-alignment with big pharma. FDA referred the telehealth company to the Department of Justice and has indicated it will restrict GLP-1 API ingredients.

Patent Infringement Allegation in Novo Lawsuit Novel Against 503A

...this is the first patent infringement case against semaglutide 503A compounding.

While it’s no surprise that Novo claimed an inferior compounded product pursuant to its testing, this is the first patent infringement case against semaglutide 503A compounding. The compounded offering was presumably not ‘essentially a copy’ with a different formulation and different (i.e. liposomal) release technology. Previous patent infringement lawsuits have been the result of Hatch Waxman generic drug lawsuits and, in some cases, Novo’s patents have been invalidated by generic companies.1 The EPO has also revoked several semaglutide patents for ‘lack of inventive step (i.e. obviousness). The patent at issue is U.S. 8,129,343 which describes various pharmaceutical compositions comprising semaglutide for treating type 2 diabetes using SNAC delivery technology. The use of Novo’s patented SNAC technology is the key barrier for compounded semaglutide pills and presumably the Hims & Hers formulation does not utilize this technology. It is interesting that Novo has decided to take a vulnerable position on its patents being invalidated in it’s contest with Hims & Hers.

FDA Enforcement Overreach

In an unprecedented move, FDA referred the telehealth company to the Department of Justice (DOJ) for potential violations of the Federal Food, Drug & Cosmetic (FD&C) Act. No doubt FDA is reacting to the wider threat to the new drug approval process that a compounded version could present. FDA also stated that it plans to take ‘decisive steps’ to restrict GLP-1 Active Pharmaceutical Ingredient (API) for compounding.

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While FDA appears to have stepped up efforts to prohibit importation of substandard API from foreign suppliers, most notably by increasing unannounced foreign inspections and creating a ‘green and red list’, it remains to be seen what actual ‘decisive steps’ to limit API FDA is contemplating. It could take the form of increased ‘red’ listing of API foreign manufacturers, inspections and Warning letters or even seizures. FDA could also proceed with a Notice and Comment process to add semaglutide to the not yet-existent Demonstrably Difficult to Compound List (DDC) (which the manufacturer has petitioned FDA for several years ago). FDA issued a proposed DDC rule that would prohibit compounding of liposomal delivery such as that of the Hims & Hers pill (has been used for other drugs like compounded testosterone). At that time the proposed rule sparked significant debate with FDA receiving numerous comments on the language used as well as a lack of statutory authority. The proposed DDC rule which would significantly reign in mass compounding such as by automated compounding techniques has yet to be finalized. It is interesting that FDA has targeted a particular API class and stated it intends to restrict that API for compounding.

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Marketing, Counseling, and Documentation Risks in the Post-Wegovy® Era

It is an exciting time to be an FDA/Intellectual property attorney. If you are an importer, 503A compounding pharmacy, this should be viewed as a regulatory/legal escalation event that materially increases legal exposure across dispensing, marketing, reimbursement, and compounding practices.

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Oral semaglutide introduces administration specific requirements that raise the standard for pharmacist counseling and documentation. Improper timing, food intake, or missed dosing can directly affect efficacy and adverse event risk. When outcomes fall short or side effects occur, pharmacies should expect closer scrutiny of counseling records, workflows, and staff training. In this environment, routine dispensing is no longer a safe assumption.

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Marketing risk has also increased. The availability of a branded oral option sharpens enforcement focus on how pharmacies describe GLP-1 therapies to consumers. Weight loss claims that overpromise results, blur FDA approved indications, or fail to clearly distinguish branded products from compounded alternatives create exposure under consumer protection laws and state pharmacy regulations. As GLP-1 advertising expands, the likelihood of complaints, audits, and disciplinary action increases.

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Compounding risk may be the most immediate pressure point. With an FDA approved oral semaglutide now commercially available, regulators and payors are already questioning whether compounded GLP-1 practices remain justified, particularly where prior reliance was tied to access or formulation limitations. Pharmacies engaged in compounding, substitution, or alternative sourcing should expect significantly less tolerance moving forward.

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This is the moment for proactive legal review. Policies, training materials, marketing content, compounding decisions, and third party relationships should be evaluated now, before regulators, payors, or plaintiffs do it for you.

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Reimbursement scrutiny is accelerating as well. PBMs and payors are reassessing formulary placement, prior authorization criteria, and utilization controls for GLP-1 therapies. Pharmacies should anticipate more frequent audits, tighter documentation standards, and aggressive recoupment activity tied to medical necessity and dispensing patterns. Oral semaglutide complicates reimbursement rather than simplifying it.

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Taken together, the approval of oral semaglutide represents a compression of risk for pharmacies. Gray areas around counseling, marketing language, compounding, and coverage are rapidly becoming defined enforcement targets. Pharmacies that wait for guidance, audits, or warning letters may find themselves responding too late.

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This is the moment for proactive legal review. Policies, training materials, marketing content, compounding decisions, and third party relationships should be evaluated now, before regulators, payors, or plaintiffs do it for you.

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If your pharmacy dispenses, compounds, markets, or bills for GLP-1 therapies, now is the time to speak with Dr. Martha Rumore about how this approval changes your exposure and what steps to take before enforcement activity begins.