Hims & Hers Health, Inc. Has abruptly halted sales of a cheaper, compounded version of Novo Nordisk’s weight-loss drug Wegovy, conceding ground to the Danish pharmaceutical giant and retreating from a strategy that drew scrutiny from the U.S. Food and Drug Administration. The move, announced on , comes less than 24 hours after the FDA signaled it would investigate companies offering compounded versions of popular weight-loss medications.
The telehealth company had launched the copycat Wegovy on , pricing it at $49 per month – significantly lower than Novo Nordisk’s list price of $149 for the lowest dose. Hims & Hers’ offering contained semaglutide, the active ingredient in Wegovy, and aimed to capitalize on surging demand for weight-loss treatments. Novo Nordisk immediately condemned the move as illegal mass compounding and vowed to pursue legal action to protect its intellectual property and patient safety.
“We have decided to stop offering access to this treatment,” Hims & Hers stated, effectively ending a challenge that briefly rattled investors and raised questions about the regulatory boundaries of compounded drugs. The company’s stock price had initially spiked on the announcement of the cheaper Wegovy alternative but subsequently declined, falling approximately 15% after markets closed on , following the FDA’s enforcement threat.
The retreat underscores the risks associated with Hims & Hers’ business model, which has often involved offering lower-cost alternatives to branded pharmaceuticals. The company has previously faced FDA scrutiny over its marketing of compounded versions of Ozempic, another Novo Nordisk drug containing semaglutide, and has been warned about deceptive advertising practices. Last year, the FDA sent warning letters to drug companies regarding claims made in their advertisements, with Hims & Hers’ Super Bowl commercial specifically cited as a concern.
Novo Nordisk’s Wegovy, the first oral version of a weight-loss drug to receive regulatory approval worldwide, has seen strong initial uptake since its U.S. Launch in early . Novo Nordisk CEO Mike Doustdar reported that 170,000 people were already using the medication as of .
The legal threat from Novo Nordisk centered on patent protection for Wegovy. Wall Street analysts pointed out that Hims & Hers’ compounded version risked infringing on those patents, exposing the company to potentially costly litigation. Novo Nordisk’s statement explicitly accused Hims & Hers of engaging in “illegal mass compounding that poses a significant risk to patient safety.”
Hims & Hers’ decision to withdraw the Wegovy copy comes as the company attempts to diversify its product offerings beyond cheaper versions of popular weight-loss drugs. The company’s shares are currently trading at their lowest level since , reflecting investor concerns about its long-term growth prospects. The company is scheduled to air a commercial during the upcoming Super Bowl on .
The broader implications of this episode extend beyond Hims & Hers and Novo Nordisk. It highlights the growing tension between pharmaceutical companies seeking to protect their intellectual property and telehealth providers aiming to offer more affordable access to medications. The FDA’s intervention signals a willingness to crack down on practices that could compromise patient safety or violate drug regulations. The agency’s scrutiny of compounded drugs is likely to intensify as demand for weight-loss treatments continues to rise, and as more companies explore strategies to circumvent the higher prices of branded medications.
The situation also underscores the challenges faced by companies attempting to replicate or offer alternatives to blockbuster drugs like Wegovy. While compounded medications can offer a lower-cost option, they are subject to less stringent regulatory oversight than FDA-approved drugs, raising concerns about quality control and potential risks to patients. The legal battle between Hims & Hers and Novo Nordisk will likely set a precedent for how these types of disputes are resolved in the future, and could have a significant impact on the telehealth industry’s ability to offer compounded medications.
