Novo Nordisk Files Lawsuit Against Hims & Hers Over Compounded Semaglutide Products
Krissy Vann | Host, All Things Fitness and Wellness
Novo Nordisk announced February 9 that it has filed a lawsuit in the United States against telehealth company Hims & Hers, alleging patent infringement related to compounded semaglutide products offered in the U.S. market.
According to Novo Nordisk, the lawsuit alleges that Hims & Hers infringes U.S. Patent No. 8,129,343 through the marketing and sale of compounded semaglutide products that are not approved by the U.S. Food and Drug Administration. Novo Nordisk stated that it is seeking a court order to permanently prohibit the sale of these compounded products, as well as monetary damages.
In its filing, Novo Nordisk alleges that Hims & Hers has promoted compounded injectable semaglutide products and briefly introduced, then discontinued, an oral compounded GLP-1 product shortly after Novo Nordisk launched an FDA-approved oral formulation of Wegovy. The company asserts that compounded versions are being marketed in a way that may cause confusion among consumers and healthcare professionals regarding their regulatory status.
Novo Nordisk further stated that compounded semaglutide products are not reviewed or approved by the FDA for safety, quality, or effectiveness. The company cited internal testing results that it says showed high levels of impurities in certain compounded semaglutide samples. These claims have not been independently verified and were not detailed in court filings released publicly at the time of the announcement.
The company also referenced recent statements from the FDA regarding compounded GLP-1 medications, noting that the agency has stated it cannot verify the quality, safety, or efficacy of certain compounded versions of these drugs. Novo Nordisk additionally cited positions from medical organizations, including the American Medical Association, the American Diabetes Association, and the Endocrine Society, which have expressed caution around the use of compounded GLP-1 medications.
Novo Nordisk said the lawsuit is part of broader efforts to address the use of compounded versions of GLP-1 drugs, alongside prior legal actions and educational initiatives. The company also stated that FDA-approved Wegovy and Ozempic products are currently available in the U.S. market.
Hims & Hers has not publicly responded to the lawsuit as of the time of publication.
