By Blake Brittain
Feb 10 (Reuters) – Novo Nordisk’s U.S. patent lawsuit towards Hims & Hers, filed on Monday, marks a brand new entrance within the Danish pharmaceutical drugmaker’s marketing campaign towards firms promoting compounded variations of its blockbuster weight-loss drug Wegovy.
The case, Novo’s first U.S. patent infringement lawsuit towards a compounder over Wegovy, comes as massive telehealth firms have expanded quickly into the weight-loss drug market, and after the U.S. Meals and Drug Administration decided that the drug’s energetic ingredient semaglutide is not briefly provide.
That shift, consultants say, has diminished issues that implementing patents might set off a public backlash by trying to restrict entry to a scarce drug.
Novo’s lawsuit follows Hims’ launch on Thursday of a $49 compounded model of Wegovy, after which a fast retreat, after the FDA introduced it could take motion towards the corporate on Friday.
In a press release, Hims stated the lawsuit “assaults greater than only one treatment or firm – it instantly assaults a well-established, very important element of US pharmacy observe that has improved affected person take care of every thing from weight problems to infertility to most cancers.”
Novo’s criticism didn’t specify how a lot the corporate was in search of in damages, however Novo’s normal counsel John Kuckelman informed Reuters it was a “very vital quantity.”
RAPID SCALE-UP
The San Francisco-based telehealth firm has grown rapidly. It stated in November that it anticipated its whole 2025 income to be greater than $2.3 billion, and has focused $6.5 billion in income by 2030.
“The earlier established order was that pharmaceutical firms weren’t suing compounding pharmacies for these individualized doses as a result of they have been thought-about to be minor, however the firms have clearly scaled up,” stated Sarah Rajec, a professor at William & Mary Regulation College.
U.S. laws permit compounding pharmacies to make and promote some brand-name medicines if they’re briefly provide. And not using a scarcity, nonetheless, compounding is usually permitted solely when a drug is custom-made for a specific affected person.
The FDA first listed semaglutide as briefly provide in 2022, which allowed compounding to proliferate. The company declared the scarcity was over in February 2025, however Hims continued to promote what it calls “customized” doses of semaglutide, arguing that such gross sales are lawful when sufferers require doses Novo doesn’t supply.
LEGAL FIGHT ESCALATES
Novo had beforehand sued a number of smaller compounding pharmacies for allegedly promoting harmful or falsely marketed Wegovy “knockoffs” that violate its trademark rights. These circumstances targeted on the security of the compounded merchandise and alleged misconduct throughout a interval when the semaglutide scarcity heightened sensitivity round entry to the drug.
