Novo Nordisk, the pharmaceutical company responsible for manufacturing Ozempic and Wegovy, has initiated several lawsuits against generic versions of these highly sought-after drugs.
In an official statement, the company declared its intent to take legal action against specific establishments such as medical spas, weight loss or wellness clinics, and compounding pharmacies. The lawsuits primarily target “the unlawful marketing and sales of non-FDA approved counterfeit and compounded semaglutide products claiming to contain semaglutide,”, including allegations of false advertising, trademark infringement, and the illegal sale of non-FDA-approved compounded products.
The recent lawsuits come in the wake of recent safety advisories issued by federal regulators due to the increasing popularity of semaglutide, the active ingredient in Ozempic and Wegovy, for weight loss purposes. These medications can be quite expensive, exceeding $1,000 per month without insurance coverage. As a result, some individuals have reportedly turned to compounding pharmacies as an alternative to combat the high costs, as mentioned in reports from ABC News.
In a press release, Doug Langa, the executive vice president of North America operations and president of Novo Nordisk, emphasized “Our priority is to ensure that patients have a safe and positive experience with our FDA-approved semaglutide medicines. Further, the legal actions taken by Novo Nordisk are a “direct reflection of this focus on patient well-being”.
Recently, the U.S. Food and Drug Administration (FDA) disclosed that it had received reports of adverse events following the administration of semaglutide injections obtained from a compounding pharmacy. The FDA defines compounding as “the process of combining or mixing ingredients” to create a “tailored” medication. In response to these reports, the FDA issued a safety warning, “Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality.”
In addition, Novo Nordisk unveiled a “resource hub” in the United States, recently. This hub aims to provide comprehensive information about semaglutide, including guidance on identifying “counterfeit injectable product.” “We believe it’s important to provide additional tools and education to support the proper use of our approved semaglutide products and create broad public awareness regarding the difference between our FDA-approved medicines and other products being labeled as semaglutide states Doug Langa, the company’s executive vice president of North America operations and president.
