Novo Nordisk has initiated legal action against online telehealth provider Hims & Hers, alleging that the company has been unlawfully marketing cheaper, unapproved versions of Novo’s Wegovy obesity medication. The lawsuit, filed in the U.S., seeks to permanently prohibit Hims from selling compounded formulations that infringe on Novo’s patents and demands damages for the alleged infringement.
The legal confrontation escalates an ongoing dispute as Hims previously announced it would cease offering its copycat obesity pills following increased scrutiny from federal regulators and the looming threat of legal repercussions from Novo Nordisk. Hims had proposed pricing its oral version at around $49 for the initial month, significantly undercutting the approved Wegovy medication, which costs approximately $100 more.
In a statement on Monday, Hims described the lawsuit as “a blatant attack” on Americans who depend on compounded medications for personalized healthcare. The company accused Novo Nordisk of “weaponizing the US judicial system” to curtail consumer options. Hims emphasized its commitment to ensuring safe access to personalized healthcare solutions for its patients.
Financial repercussions of the lawsuit were immediate, with Novo Nordisk’s shares rising more than 5% on the Copenhagen stock exchange, while Hims’ shares experienced a decline of 21% in premarket trades on the New York Stock Exchange.
This legal challenge coincides with Novo’s efforts to regain market share in the expanding obesity treatment sector amid fierce competition from Eli Lilly and various compounded alternatives. Such alternatives have emerged due to regulatory loopholes permitting companies like Hims to offer compounded versions of brand-name drugs when those products are in limited supply.
The active ingredient in Wegovy, semaglutide, has recently become readily available in the U.S. as Novo raised its manufacturing capacity, and reports indicate there are currently no shortages of Wegovy. Despite this, Novo estimated that around 1.5 million Americans are still using compounded GLP-1 drugs.
Hims claims that its compounded pills and other GLP-1 products include semaglutide, asserting their legality based on a “personalized” dosage approach. However, Novo Nordisk maintains that it does not supply semaglutide for use in copycat products and has accused Hims of illegal mass compounding practices.
Novo’s group general counsel, John Kuckelman, emphasized that the company is not seeking to eliminate all compounding practices but aims to stop illegal mass compounding. He stated that legitimate compounding should only occur on a case-by-case basis, primarily when it is medically necessary for individual patients.
The scrutiny surrounding Hims intensified when the Food and Drug Administration (FDA) revealed plans to take legal action against the company for the sale of its pill. This includes potential restrictions on the ingredients used and referral to the Department of Justice for possible violations.
Kuckelman noted that some telehealth platforms are responsibly transitioning towards offering FDA-approved products, which he sees as a positive shift. However, he expressed concern that others, like Hims, may only be deterred through legal actions and government enforcement measures.
Over the past two years, both Novo Nordisk and Eli Lilly have ramped up efforts to challenge compounding pharmacies, benefiting from the increased popularity of their diabetes and weight-loss medications. Novo Nordisk has filed around 130 lawsuits targeting deceptive marketing and consumer fraud, while Eli Lilly has pursued similar legal avenues concerning its products.
