Novo Nordisk Sues Telehealth Firm Over Compounded GLP-1 Weight Loss Drugs

Novo Nordisk filed a patent infringement lawsuit against Hims & Hers over compounded versions of Wegovy. The legal action follows the telehealth company's announcement of a $49 oral pill, which was withdrawn after FDA warnings.

Novo Nordisk has initiated legal proceedings against Hims & Hers on February 9, accusing the telehealth provider of patent infringement by selling alternative versions of Wegovy. The company has agreed to pay Roivant up to $2.25 billion to settle claims that it infringed on Roivant's patents with its Covid-19 shot in a separate matter.

The lawsuit followed closely after Hims & Hers announced it would offer a compounded Wegovy pill at an introductory rate of $49 per month. Shortly after the FDA warned of potential enforcement, Hims & Hers withdrew its plans. The decision by Hims & Hers to introduce a pill form of Wegovy was described as the tipping point, with company representatives emphasizing that there was never a shortage of the oral version, and thus no justification for a compounded alternative.

The general counsel stated, "There's no justification based on shortage. It's not only a violation of our patents, which we take seriously, but also challenges the entire drug approval process in the U.S." The company expects all compounding pharmacies engaged in large-scale production to pay attention to this lawsuit and consider the possible repercussions of their ongoing practices.

Originally, compounded drugs were meant to be widely available only during shortages of the branded medications. However, even after the Food and Drug Administration announced the end of the shortage in 2025, telehealth companies have continued to supply compounded anti-obesity drugs, often adjusting dosages and offering them at prices lower than those of the original manufacturers.

Hims & Hers declined to provide an interview, but stated that effective obesity treatment requires individualized care. The company continues to offer injectable GLP-1 medications. "Access limitations, high costs, and a one-size-fits-all approach are not necessary for quality healthcare," Hims & Hers stated. "Our customer-focused model removes barriers found in traditional healthcare, empowering consumers to take charge of their health."

The company reports having around 2.5 million subscribers across its health services, with GLP-1 users making up a small fraction of their customer base.

Currently, Novo Nordisk is the sole company with FDA approval for an oral GLP-1 weight-loss medication, giving them exclusive rights to market the pill to those preferring it over injections. During a recent earnings call, executives highlighted the rapid uptake of their oral medication, with over 50,000 prescriptions being filled weekly and most early adopters paying cash. The starting price for the Wegovy pill is $149, which is about $200 less than the injectable version.

This exclusivity may soon end, as Eli Lilly's oral weight-loss drug, orforglipron, could receive FDA approval as early as April.

According to the health policy organization KFF, approximately one out of every eight Americans uses a GLP-1 medication for weight management, diabetes, or related health issues. Many of these individuals face financial barriers because their insurance does not cover these drugs. A survey found that 49% of large employers covered GLP-1 drugs in 2025, up from 41% in 2023.

Both Novo Nordisk and Eli Lilly have reduced prices for those paying out of pocket due to lack of insurance coverage. Consumers can purchase Wegovy or Zepbound directly from pharmaceutical companies, through telehealth services, or at retailers like Costco, Sam's Club, and the TrumpRx direct-to-consumer website.

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References

  1. FDA warns more telehealth firms about compounded GLP-1s - Stat News · statnews.com
  2. GLP-1 battle: Wegovy manufacturer confronts companies producing imitation weight loss ... · bitget.com
  3. My biggest GLP-1 ethical problem: patients who don't want to stop - STAT · statnews.com