Novo Nordisk Sues Hims & Hers for Making Similar Weight-Loss Drugs

Novo Nordisk, the company that makes popular weight-loss drugs like Wegovy, has sued Hims & Hers. Novo Nordisk says Hims & Hers is making and selling similar drugs that are not approved in the same way. This lawsuit is about protecting patients and patented medicines.
By Newsroom | Health, Legal |

Tension is high in the booming market for weight-loss medications as Novo Nordisk, the maker of popular drugs like Wegovy and Ozempic, has initiated legal action against telehealth company Hims & Hers. Novo Nordisk claims Hims & Hers is unlawfully producing and marketing "compounded" versions of its patented semaglutide-based treatments, which are used for weight loss and Type 2 diabetes management. The lawsuit alleges patent infringement and risks to patient safety. This legal confrontation follows Hims & Hers' recent launch of a cheaper, compounded weight-loss pill, and a subsequent decision by Hims to halt sales of that specific pill after facing pressure from regulators and Novo Nordisk.

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Background of the Dispute

The core of the conflict centers on semaglutide, the active ingredient in Novo Nordisk's highly successful medications Wegovy (for weight loss) and Ozempic (for Type 2 diabetes). These drugs, which belong to the GLP-1 class, have seen immense popularity in recent years, leading to a significant expansion of the weight-loss drug market.

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  • Novo Nordisk's Products: Novo Nordisk manufactures FDA-approved, non-compounded versions of semaglutide, available as injectables (Wegovy, Ozempic) and, more recently, a pill form of Wegovy. These products undergo rigorous testing and regulatory oversight.

  • Hims & Hers' Offerings: Hims & Hers, an online health service, has been providing compounded versions of semaglutide. Compounded drugs are created by mixing ingredients to customize medications for individual patients. These compounded versions, often available at a lower cost, have become a point of contention.

  • Escalating Actions: The recent legal action by Novo Nordisk was triggered by Hims & Hers launching a new, compounded weight-loss pill. Novo Nordisk had previously issued warnings. Following these threats and scrutiny from the Food and Drug Administration (FDA), Hims & Hers announced it would stop selling this specific pill.

Novo Nordisk's lawsuit, filed in the District Court of Delaware, outlines several key allegations against Hims & Hers:

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  • Patent Infringement: Novo Nordisk asserts that Hims & Hers is violating the patent rights covering Novo Nordisk's brand-name semaglutide drugs through the marketing and distribution of compounded versions. This is reportedly the first time Novo Nordisk has sued over patent infringement related to compounded semaglutide.

  • Deceptive Practices and Patient Risk: The Danish drugmaker argues that Hims & Hers is engaging in "unlawfully mass compounding" and marketing these products in a way that is "dangerous and deceptive to patients." Novo Nordisk contends that compounded drugs generally do not undergo the same level of safety and efficacy vetting as standard, FDA-approved medications, potentially putting patient health and well-being at risk.

  • Undermining Innovation: Novo Nordisk suggests that the practices of Hims & Hers undermine the "scientific innovation and regulatory rigor" put in place to ensure the safety and effectiveness of these treatments.

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Hims & Hers, in response, has characterized the lawsuit as a "blatant attack" on consumers who depend on compounded medications.

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Regulatory Scrutiny and Market Impact

The dispute has also drawn the attention of regulatory bodies:

  • FDA Involvement: The Food and Drug Administration (FDA) has reportedly threatened action against Hims & Hers. This external pressure contributed to Hims & Hers' decision to halt sales of its new compounded weight-loss pill.

  • Market Dynamics: The intense demand for GLP-1 drugs has fueled a multibillion-dollar market. Companies like Hims & Hers are seeking to capitalize on this demand, often offering more affordable alternatives. Novo Nordisk and Eli Lilly (maker of Zepbound and Mounjaro) have been actively confronting compounding pharmacies to protect their market share and perceived product integrity.

Novo Nordisk's Broader Strategy

This lawsuit is part of a wider effort by Novo Nordisk and other major pharmaceutical companies to address the proliferation of compounded versions of their popular weight-loss and diabetes drugs. Novo Nordisk has reportedly filed approximately 130 lawsuits in the past two years concerning deceptive marketing and consumer fraud related to these products.

Next Steps

While Hims & Hers has stated it will stop selling the specific compounded pill that drew Novo Nordisk's ire, the broader legal battle over the sale and compounding of semaglutide-based medications is ongoing. Novo Nordisk is seeking a permanent injunction to prevent Hims & Hers from selling infringing compounded drugs and is pursuing damages. The outcome of this lawsuit could have significant implications for the accessibility and regulation of compounded medications within the rapidly expanding GLP-1 drug market.

Sources

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Frequently Asked Questions

Q: Why is Novo Nordisk suing Hims & Hers?
Novo Nordisk says Hims & Hers is making and selling drugs that are too similar to its own patented weight-loss drugs, like Wegovy. They are worried about patient safety and their patents.
Q: What are compounded drugs?
Compounded drugs are made by mixing ingredients to create a specific medicine for a person. They are not tested the same way as drugs approved by the FDA.
Q: Did Hims & Hers stop selling the drug?
Yes, Hims & Hers stopped selling the specific weight-loss pill that Novo Nordisk was most upset about. But the lawsuit is still happening.
Q: Is this the first time Novo Nordisk has sued?
No, Novo Nordisk has sued many other companies that make similar compounded drugs. This is part of a bigger effort to protect their medicines.