Novo Nordisk Sues Hims & Hers Over Alleged Unapproved Wegovy Copycats
Novo Nordisk has initiated a lawsuit against online telehealth provider Hims & Hers in the U.S. The pharmaceutical company alleges that Hims & Hers is mass marketing unapproved, compounded versions of its Wegovy obesity drug, thereby infringing on Novo Nordisk's patents. The lawsuit seeks a permanent injunction to prevent Hims from selling these compounded drugs and demands damages.
Novo Nordisk Alleges "Complete Sham" and Patient Risks
John Kuckelman, Novo Nordisk’s group general counsel for global legal, intellectual property, and security, stated that Hims' medicines are "untested" and pose risks to patients, describing the practice as a "complete sham." He further highlighted that the safety, efficacy, and quality of compounded medicines are not verified by U.S. regulators.
"Hims' medicines are 'untested' and pose risks to patients, describing the practice as a 'complete sham'." - John Kuckelman, Novo Nordisk
This legal action follows Hims & Hers' announcement on Saturday that it would cease offering its new copycat obesity pill after facing scrutiny from federal regulators and legal threats from Novo Nordisk. Hims had planned to offer its oral drug for approximately $49 for the first month, a significantly lower price than Novo's approved Wegovy pill.
Hims & Hers Responds: A "Blatant Attack" on Consumers
In response to the lawsuit, Hims & Hers issued a statement calling it "a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care." Hims also suggested it was an instance of Big Pharma "weaponizing the US judicial system to limit consumer choice," while asserting its history of providing safe access to personalized healthcare.
Hims & Hers views the lawsuit as "a blatant attack... on millions of Americans who rely on compounded medications for access to personalized care," suggesting Big Pharma is "weaponizing the US judicial system to limit consumer choice."
Market Reaction and Broader Competition
In financial markets, Novo Nordisk's Copenhagen-listed shares increased by more than 5%, while Hims' NYSE-listed stock decreased by 21% in premarket trading.
The lawsuit occurs as Novo Nordisk endeavors to regain market share in the growing obesity drug market and compete against Eli Lilly and various compounded alternatives. These compounded versions have proliferated under a regulatory provision that permits their sale when branded treatments are experiencing shortages. However, semaglutide, the active ingredient in Novo's pill and injections, is no longer in shortage in the U.S. The Wegovy pill, launched in early January, has also not experienced reported shortages.
The Compounding Debate: "Personalized" vs. "Mass Compounding"
Novo Nordisk estimated in January that approximately 1.5 million Americans are utilizing compounded GLP-1 drugs. Hims & Hers maintains that its compounded pill and other GLP-1 products contain semaglutide, arguing their versions are legal due to being "personalized" in dosage, despite U.S. patents on the ingredient extending through 2032.
Novo Nordisk asserts that it does not directly or indirectly sell semaglutide for copycat products and accuses Hims of engaging in illegal mass compounding. Kuckelman clarified that Novo Nordisk aims to end "unlawful mass compounding" rather than all compounding practices, emphasizing that legitimate compounding should be based on medical necessity for individual patients, such as for specific allergies or administration difficulties, as opposed to mass production of dosage variations presented as personalized medicine.
Novo Nordisk aims to end "unlawful mass compounding," distinguishing it from legitimate compounding which should be based on medical necessity for individual patients—not mass production of dosage variations presented as personalized medicine.