Beyond the Label: Protecting Consumer Trust in a Compounded World

Beyond the Label: Protecting Consumer Trust in a Compounded World

By Michelle L. Visser

Novo Nordisk is a Danish pharmaceutical company that makes the wildly successful drugs OZEMPIC® and WEGOVY®.  These drugs are “glucagon-like peptide-1 (GLP-1) receptor agonists” whose generic name is semaglutide.

From mid 2022 until February of 2025, semaglutide was on the Food and Drug Administration Drug Shortages List, which enabled pharmacies and weight loss companies to compound semaglutide to make copycat versions of Novo Nordisk’s products, even though the drugs were still under patent protection.  Under the Federal Food, Drug, and Cosmetic Act (FDCA), when a drug is listed as in shortage, Section 503A and 503B allow pharmacies to compound versions of the drug—even if it is patented—provided they are not “essentially a copy” of a commercially available product.

While semaglutide was on the national shortage list, Novo Nordisk relied heavily on the trademark laws for its intellectual property enforcement efforts.  It filed numerous trademark infringement and false advertising lawsuits against compounders that used the OZEMPIC and WEGOVY names to indicate the comparability of their compounded semaglutide to Novo Nordisk’s products. 

Normally, a de minimis use of a competitor’s trademark to enable consumers to compare products qualifies as a fair use of a competitor’s trademark under the trademark laws.  In the advertising of their products, the compounders had made statements along the lines of “compounded semaglutide achieves the same results as Ozempic or Wegovy” and “compounded semaglutide has the same active ingredient as Ozempic or Wegovy.”  Novo Nordisk argued that these compounders improperly used its trademarks for pharmaceutical products whose safety had not been proven.

Higher care is given to protection of drug names because of the potential harm to consumers if consumers are confused by drug names.  The consequences of confusing two medications could be deadly, while confusing two brands of shampoo would just be aggravating.  The Trademark Office applies a stricter standard for registration of trademarks for pharmaceuticals.  The Food and Drug Administration must also approve all new drug names, and it conducts its own review for possible confusing or misleading names.  And finally, the USAN Council approves all generic names (such as semaglutide) for new drugs.  USAN conducts its own search for similar generic names to ensure safety, consistency and logic in the choice of names by avoiding conflict, misleading and confusion with other generic names and trademarks.

Novo Nordisk may well have benefited from this elevated standard in its enforcement activities.  Its lawsuits against the compounders have largely been successful and largely were settled early. 

After the FDA took semaglutide off the drug shortages list, Novo Nordisk was free to resume enforcement of its intellectual property rights in these drugs using both trademark and patent laws. It filed over a dozen new lawsuits in August alleging a combination of patent and trademark infringement.

As Novo Nordisk intensifies its enforcement efforts, the company is sending a clear message: it will aggressively protect its semaglutide-based therapies using all of the legal tools available to it. With the FDA shortage designation lifted and legal momentum building, these renewed actions mark a pivotal moment in the evolving landscape of GLP-1 treatments, setting a precedent for how drugmakers may defend their intellectual property in the face of compounding and commercialization challenges.

Michelle Visser is a partner of Fishman Stewart, with over 25 years of experience practicing trademark law with other members of the firm’s Trademark Group. Check out her full bio here.

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