Novo Nordisk takes legal action against Hims & Hers to protect patients from knock off Wegovy

Novo Nordisk has recently announced that they have filed a lawsuit against telehealth company Hims & Hers for infringing US Patent 8,129,343 with Hims’ compounded semaglutide products for the US market. Hims has engaged in promotional campaigns that highlight its compounded semaglutide products, duping consumers and healthcare professionals as to the clinical benefits and safety of these unapproved drugs. Including Hims’ recent launch, and two days later, abrupt discontinuance of its “Compounded GLP-1 Pill,” which came on the heels of Novo Nordisk’s introduction of the Wegovy pill, the first and only FDA-approved GLP-1 pill for weight loss. Hims continues to unlawfully mass compound injectable versions, made with inauthentic API, and these knock-offs are putting patient health and wellbeing at risk.

“Throughout Novo Nordisk’s 103-year-long history, patient safety has always been our top priority. Hims & Hers is mass marketing unapproved knock-off versions of Wegovy^® and Ozempic^® that evade the FDA’s gold standard review process – that’s dangerous and deceptive to patients, and undermines the scientific innovation and regulatory rigor in place to ensure these treatments are safe and effective,” said John F. Kuckelman, senior vice president, Group General Counsel, Global Legal, IP and Security. “We’ve taken legal action to protect the American public and our intellectual property and will continue to work with regulators, law enforcement, and other key stakeholders to ensure patients have access to FDA approved safe and effective medicines.”

Note that mass marketing by Hims and compounding pharmacies has flooded the market with knock-off Wegovy^® and Ozempic^®. Compounded semaglutide products may contain dangerous impurities or incorrect amounts of active ingredients, which can result in life-threatening immune responses, hospitalization, severe drug-drug interactions, and overdoses. According to Novo Nordisk’s testing, injectable semaglutide drugs compounded by pharmacies were found to contain impurities of up to 86%, with compounded oral semaglutide drugs containing impurities as high as 75%. Even in small quantities, such impurities can negatively impact the safety and efficacy of a drug product, including unwanted immune responses like anaphylactic shock.

Compounded GLP-1 drugs mass-marketed by Hims and other compounding pharmacies are “drugs for which the FDA cannot verify quality, safety, or efficacy.” Respected organizations and experts in the medical community, such as the American Medical Association, the American Diabetes Association, and the Endocrine Society, have voiced similar concerns about knock-off GLP-1 drugs and the risk they pose to patients. The ADA recommends against using these knock-offs due to uncertainty about their content, safety, quality, and effectiveness.

 

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