Danish weight-loss giant Novo Nordisk has lost a US patent to generics manufacturer Viatris.
A federal district court in Delaware ruled that Viatris’ product, currently awaiting approval from the US Food and Drug Administration (FDA), does not infringe on Novo Nordisk’s patent for the glucagon-like peptide-1 receptor agonist (GLP-1RA) Wegovy (semaglutide).
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Novo alleged that its five asserted patents cover Wegovy and the generic version of Wegovy that Mylan Pharmaceuticals, which is part of Viatris, asked the FDA to approve for manufacture and sale.
Viatris argued that its label does not ask patients or physicians to administer the product without another therapeutic agent for weight loss or to treat diabetes or hypertension, something which was part of Novo Nordisk’s patented method.
The court documents state that although the label instructs physicians and patients not to co-administer Viatris’ product with other semaglutide-containing products or GLP-1RA, it does not prohibit co-administration with other therapeutic agents. Consequently, the court ruled that Viatris’ label “did not intend to preclude the coadministration of those other agents with its semaglutide product”.
The judge concluded that because the proposed label “does not encourage, promote, or recommend” the use of its product without other therapies, Viatris’ drug does not induce infringement of the “administered without another therapeutic agent” limitation of claim one of the patent.
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By GlobalDataThe court documents continued that all other claims would be dropped as they rely on claim one being upheld. As a result, the court ruled a judgment of no direct, contributory, and induced infringement of the patent in Viatris’ favour.
A spokesperson for Viatris said: “We are pleased with the District Court’s favourable decision finding non-infringement of the ‘003 patent related to Wegovy, which removes it from the patent trial scheduled to begin in March 2026. We have no further comment on this ongoing legal matter at this time.”
Novo Nordisk told Pharmaceutical Technology it could not provide any further comment while the case is ongoing.
GlobalData analysis shows global sales of Wegovy reached $8.4bn in 2024, with a 2030 sales forecast of $21.39bn.
Additionally, GlobalData predicts the obesity market across the seven major markets (7MM: France, Germany, Italy, Japan, Spain, the UK and the US) will exceed $173.5bn by 2031.
GlobalData is the parent company of Pharmaceutical Technology.
Novo Nordisk’s legal showdowns continue
This ruling comes 10 months after Novo Nordisk and Viatris settled a separate patent over Novo Nordisk’s Ozempic (semaglutide); however, the terms of this settlement have not been released.
NovoNordisk has also filed lawsuits against other companies, including medical spas, wellness clinics and pharmacies for selling semaglutide-containing products.
In April 2025, a US judge rejected efforts by a compounded drugs industry group to keep making an alternative version of Novo Nordisk’s popular drug semaglutide, opening the door for the FDA to take enforcement action. This came because of compounders stepping in to manufacture semaglutide during the FDA-declared shortage of the therapy in early 2022.
When the shortage was resolved in mid-February, the Outsourcing Facilities Association (OFA), representing a group of compounding companies, filed for a temporary injunction, but this was rejected.
Editor’s note: This article has been updated to include a comment from Viatris and a response from Novo Nordisk.
