Eli Lilly is suing three medical spas and online vendors for selling products purportedly containing tirzepatide—the active ingredient in its weight-loss drug Zepbound. Similarly, Novo Nordisk has pursued legal action against a string of organizations to protect its semaglutide-based drugs from unauthorized competition and potentially unsafe copycat products. The company has filed a lawsuit against the Canadian firm Apotex to block the production of a generic version of Rybelsus, their oral semaglutide medication. That suit was filed in the U.S. District Court for the District of New Jersey and claimed infringement of 10 patents related to semaglutide. Patents for the drug are set to expire between 2030 and 2034.
In August, FDA noted that it had received 346 reports of adverse events with compounded semaglutide and 136 reports of adverse events with compounded tirzepatide, the active ingredient in Lilly’s blockbuster therapies Zepbound and Mounjaro.
Last year, Novo Nordisk found that some copycat products contained high levels of impurities (up to 33%) or lacked semaglutide entirely.
As of February this year, the company had filed about a dozen lawsuits against clinics, med spas, and compounding pharmacies in the U.S. claiming to offer semaglutide. That same month, the company entered settlements with two of those vendors that permanently banned the businesses from claiming their compounded drugs are FDA-approved medicines, using any Novo Nordisk trademarks or logos, or using “misleading” advertising.
In related news, Reuters also reported that the oral version of semaglutide (Rybelsus) reduced cardiovascular events by 14% compared to placebo. Those events included cardiovascular death, non-fatal heart attack, and non-fatal stroke. The late-stage trial included 9,650 patients with Type 2 diabetes with either established cardiovascular disease or chronic kidney disease. The drug was tested as an adjunct to standard of care.
The company plans to file for a label expansion in both the U.S. and the EU. The company plans on presenting the data at a scientific conference in 2025.GLP-1 drug patent litigation
Filed Under: Cardiovascular, Metabolic disease/endicrinology
