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Novo Nordisk is suing US telehealth company Hims & Hers to stop it selling “knock-off” versions of its weight-loss drugs, as Hims’ shares sank more than 20 per cent after regulators announced an investigation into unregulated medication.
In a Delaware district court filing on Monday, Novo accused Hims of patent infringement for semaglutide, the active ingredient in Ozempic and Wegovy. Denmark-based Novo argued it had invested billions of dollars to develop semaglutide and get it approved by the US Food and Drug Administration.
Novo’s lawsuit escalates a battle with Hims that had been simmering for months. Hims unveiled a copycat version of Novo’s new weight-loss pill last week, prompting Novo to launch the legal action. Last year, Novo ended a partnership with Hims that had been in place to boost sales.
In an interview, John Kuckelman, Novo’s general counsel, said that while the FDA allowed pharmacies to provide compounded versions of drugs to patients with specific needs and in times of shortages, those conditions did not apply to the formulation that Hims had intended to sell.
“Hims has completely thumbed their nose at the law,” Kuckelman said.
Novo had been trying to stop Hims from continuing to sell the compounded version of its injectable weight-loss treatment before the bombshell pill announcement, which caught the company by surprise.
“Last Thursday’s announcement was the tipping point. There can be no rational justification to launch . . . it was never in shortage. We’ve told the FDA and the medical community that we don’t anticipate having any shortages of that pill and yet Hims announced that they were somehow above the law.”
Separately, the FDA said on Friday it would investigate unregulated weight-loss drugs and mentioned Hims specifically, and the following day the company said it would stop offering the weight-loss pill. Hims’ share price sank 24 per cent in afternoon trading on Monday.
In a statement, Hims fired back at Novo, saying it had a long safety record.
“Novo Nordisk’s lawsuit is a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalised care,” Hims said. “Once again, Big Pharma is weaponising the US judicial system to limit consumer choice.”
Hims had planned to offer the discounted version of the Wegovy pill to retail at $49 a month, while the Novo version was introduced at $149 at the lowest dose.
The lawsuit marks a divorce between the companies, which were working collaboratively a few years ago. Compounded versions of obesity and diabetes drugs flourished after the FDA in 2022 allowed them because of supply shortages from Novo and rival Eli Lilly. Compounding drugs involves using active ingredients that replicate those in patented medicines.
Hims got its start selling erectile dysfunction and hair-loss medications. It merged with a blank-cheque company backed by Oaktree Capital Management in 2021. Its shares soared thanks to its compounded weight-loss sales, but its stock is down 60 per cent over the past year.
“Offering a copy of the pill had felt like a bridge too far and may put Hims & Hers under increased scrutiny from the FDA,” Morgan Stanley analysts said. Even before the FDA announcement, “feedback was nearly unanimous that this move was aggressive and would not likely stand up”, the analysts wrote in a note.
The lawsuit underscores the increasing legal battle between drugmakers and compounding companies.
Last year, Lilly sued a compounding pharmacy called Strive Specialities in Delaware, but the case was tossed out by a judge on procedural grounds.
Strive, which is incorporated in Wyoming, sued both Lilly and Novo in January, alleging they were “a duopoly” in the weight-loss market that had restricted competition and harmed patients. That case, which was filed in a Texas district court, is continuing.
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