Hims & Hers recently launched a compounded version of Novo Nordisk’s Wegovy pill, which was met by legal threats from the manufacturer. However, pharmacies are generally permitted to make compounded versions of drugs under certain circumstances: when there is a shortage of the drug, or by altering the formulation so the strength is at least 10% different and a clinician declares it medically necessary.
Edgar Asebey notes that Novo Nordisk and Eli Lilly have largely avoided accusing compounders of patent infringement, likely because doing so would invite a challenge before the U.S. Patent and Trademark Office and risk invalidating the very patents that protect their multibillion-dollar GLP-1 markets. The wording and footnotes in Hims’ announcement of its semaglutide pill indicate the company likely negotiated its language with the FDA as part of a corrective action plan following its warning letter. At the same time, state boards of pharmacy may increasingly scrutinize compounders’ assertions that they are dispensing personalized GLP-1 medications. Boards have already been more aggressive than the FDA in taking enforcement action in this space.
Read the full article in Endpoints News here.
Watch Endpoint News’s Webinar on this topic here, featuring Edgar Asebey.
