UPDATE: March 10, 2026 – The dispute between Novo Nordisk (“Novo”) and Hims & Hers (“Hims”) appears to have been resolved very quickly. On March 9, the companies announced an agreement allowing Hims to offer FDA-approved Wegovy® and Ozempic®, including the recently released tablets, through its telehealth platform at the same self-pay prices as other telehealth platforms. While the agreement allows Hims to offer FDA-approved versions of the Novo drugs, it requires the telehealth company to discontinue offering and advertising compounded versions of these drugs except in limited circumstances involving a documented clinical need. According to a press release by Novo, current Hims patients will also have the “opportunity to transition to FDA-approved alternatives when clinically appropriate in consultation with a health care professional.”
FDA Commissioner Makary posted the following on X (formerly Twitter): “Glad to see HIMS will stop advertising unapproved compounded drugs and instead sell FDA-approved products through its new partnership with Novo Nordisk. Importantly, they will keep them affordable (no increase in price) and limit compounded GLP-1s for rare (FDA compliant) cases.”
While the agreement resolves the immediate dispute, the broader legal and regulatory considerations surrounding compounded GLP-1 products discussed below remain unchanged. GLP-1 compounders and other telehealth platforms offering these types of products may still find themselves in a tenuous position if they continue to advertise and market these types of products. Our previous coverage continues below.
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The continued expansion of GLP-1 weight-loss therapies has introduced both commercial opportunity and evolving legal and regulatory considerations across the health care landscape. Novo’s recent federal lawsuit against Hims illustrates how brand manufacturers may increasingly use patent and regulatory frameworks to challenge the marketing and sale of compounded versions of these products. This case may signal a broader shift in how compounding practices, telehealth platforms and pharmaceutical patent rights intersect.
On Monday, February 9, 2026, a brand manufacturer filed a federal lawsuit alleging that a telehealth platform infringed patents covering semaglutide products, including Ozempic®, Wegovy® and Rybelsus®. In the complaint, the manufacturer alleges that the telehealth platform, which offers access to compounded drugs, is “attempt[ing] to circumvent the regulatory process by marketing products it describes as ‘compounded GLP-1s’ that have not been reviewed or approved by the U.S. Food and Drug Administration (“FDA”).”
The complaint further alleges that the manufacturer does not sell the semaglutide active pharmaceutical ingredient (“API”) for use in compounding and that the “accused products” were marketed directly to consumers through the telehealth platform’s online services, with prescriptions issued through affiliated medical groups and fulfillment handled by affiliated pharmacies. The manufacturer argues that the presence of semaglutide in a compounded product may implicate its patent rights, notwithstanding differences in dosage form, route of administration or distribution model.
Although the case remains in its early stages, it reflects an emerging strategy by brand manufacturers to challenge compounded GLP-1 products through patent litigation, particularly where telehealth platforms play a role in marketing, prescribing or distribution.
Background
FDA approved Ozempic® (semaglutide injection) in 2017, followed by subsequent approvals of additional semaglutide formulations and indications, including Wegovy® and Rybelsus®. By 2022, demand for these products surged and semaglutide injection products were placed on FDA’s drug shortage list. In 2024, the telehealth platform began offering access to compounded semaglutide products. According to the complaint, the platform represented on its website that its compounded GLP-1 drug products contain the same active ingredient as FDA-approved drugs and referenced Ozempic® and Wegovy® by name.
On February 21, 2025, FDA determined that the semaglutide injection product shortage had been resolved and removed those products from the drug shortage list. The complaint alleges that the platform continued offering compounded semaglutide products thereafter, which the manufacturer characterizes as large-scale manufacturing of products that are essentially copies of its FDA-approved semaglutide drugs and therefore infringe its patent rights.
This litigation also unfolds against the backdrop of a recent product development in the GLP-1 market. In December 2025, FDA approved oral Wegovy® weight-loss tablets, the first oral GLP-1 receptor agonist indicated for chronic weight management in adults. The manufacturer subsequently began making the product available in the United States in January 2026. Shortly thereafter, the telehealth platform announced access to compounded semaglutide tablets, which led not only to the lawsuit but also increased regulatory scrutiny.
In its annual 10-K filing with the Securities and Exchange Commission (“SEC”), the platform disclosed that it is the subject of an SEC investigation regarding its “public statements and disclosures regarding compounded semaglutide and related business relationships.” On February 6, 2026, FDA stated its intent to take action against non-FDA-approved GLP-1 drugs being mass-marketed as alternatives to approved products. Specifically, FDA warned that “companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA. They also cannot state compounded drugs use the same active ingredient as the FDA-approved drugs or that compounded drugs are clinically proven to produce results for the patient.” In response, on February 7, 2026, Hims announced on social media that it would no longer be offering its compounded semaglutide pill.
For health care companies operating in or adjacent to compounding, this case underscores several converging risk areas. Brand manufacturers may increasingly look to patent enforcement as a tool to challenge compounded products containing semaglutide and related GLP-1 therapies. In addition, depending on the outcome of this case, telehealth and platform-based models may face increased scrutiny and could be viewed as more than passive intermediaries where they exercise control over prescribing, pricing, fulfillment or branding.
Key Takeaways
- Compounding is not necessarily a patent “safe harbor.” FDA compounding provisions do not necessarily override or preempt patent rights. Companies should separately assess patent risk for any compounded product containing a patented API.
- Drug shortage status matters. Compounding pharmacies should closely monitor current drug shortages, as removal from the shortage list significantly narrows permissible compounding pathways.
- Regulatory enforcement is increasing. FDA and other regulatory agencies have signaled an intent to enforce compounding restrictions more aggressively in the GLP-1 space, particularly where they are marketed as alternatives to FDA-approved drug products.
- Alternative dosage forms do not eliminate risk. The outcome of this case will have implications on the booming market for weight loss therapies. Modified or alternative dosage forms will not necessarily eliminate patent or regulatory risk where the same API is used.
- Future guidance may emerge from litigation. The litigation may provide much-needed clarity regarding the boundaries of lawful compounding, particularly where patented active ingredients are involved.
For more information on drug compounding or the advertising and promotion of drugs, biologics or medical devices, please contact:
- Todd Nova at (414) 721-0464 or tnova@hallrender.com;
- Carolina Wirth at (202) 780-2989 or cwirth@hallrender.com;
- Benjamin Lockwood at (414) 721-0484 or blockwood@hallrender.com;
- Will Wurster at (317) 977-1494 or wwurster@hallrender.com; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
