Novo and Viatris settle Ozempic patent

Novo and Viatris settle Ozempic patent suit as generic entry date remains unknown

Novo Nordisk and Mylan Pharmaceuticals, now part of Viatris, have settled their patent dispute over Novo’s blockbuster diabetes drug Ozempic.

The Danish company declined to comment on the terms of its confidential settlement agreement with Mylan on Monday. Novo has until 2032 before key US patents expire for its weight loss and diabetes drugs Wegovy and Ozempic, according to its 2023 full-year report. But when Mylan filed an application to market its generic version sooner, the company took legal action.

Novo filed a lawsuit against Mylan in 2022, which was eventually consolidated with similar cases against other generics makers in Delaware federal court.

On Oct. 2, Mylan and Novo told judge Colm Connolly that they had settled the dispute, and requested to dismiss the claims against Mylan. The companies also filed to withdraw Mylan’s ongoing case against one of Novo’s patents at the US Patent Office’s Patent Trial and Appeal Board.

Ozempic earned $14 billion in 2023 sales, and Wegovy generated another $4.6 billion.

Novo Nordisk’s fierce strategy around Ozempic and Wegovy has also included a litany of lawsuits against medical spas, weight loss clinics and telehealth companies marketing compounded versions of the semaglutide products.

Viatris did not respond to a request for comment.

With a new patent settlement, generic partners Mylan and Natco have cleared one hurdle to a potential U.S. launch of their generic to Novo Nordisk's wildly popular Type 2 diabetes drug Ozempic.

Mylan Pharmaceuticals and Novo Nordisk have reached a settlement in a patent lawsuit tied to Ozempic, also known as semaglutide, India’s Natco Pharma said (PDF) in a filing on India’s National Stock Exchange Monday. The settlement terms are confidential, according to Natco.

Natco and Mylan—which is now part of Viatris—are working together on the development of generic Ozempic, with Indian CDMO Stelis Biopharma signed on as a manufacturing partner, Natco explained in the filing.

A Novo spokesperson confirmed over email that the company reached a settlement with Mylan. Viatris, for its part, did not immediately respond to Fierce Pharma's request for comment.

Novo’s Ozempic is approved to treat Type 2 diabetes and reduce cardiovascular risk in diabetes patients with known heart disease, though the med has experienced a popularity boom in recent years as an off-label treatment for weight loss. The drug is underpinned by the molecule semaglutide, which is also the main ingredient in Novo’s approved obesity therapy Wegovy.

Ozempic generated roughly $14 billion in sales last year, while Wegovy brought home some $4.5 billion for all of 2023.