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.
Since January 2023, Novo Nordisk has sued Mylan at least twice over its efforts to advance a semaglutide generic. Two of the lawsuits specifically concern Wegovy, while the settlement announced Monday is focused solely on Ozempic.
Ozempic and Wegovy are slated to lose patent protection in the U.S. beginning in 2032, according to the Danish company’s 2023 annual report.
With a settlement now in place, Mylan and Natco could have a major advantage in the race to supply copycats of Novo’s megablockbuster diabetes drug.
Natco has first-to-file rights for certain Ozempic doses and all doses of Wegovy, which could grant the company and its partner Mylan a significant edge in the market should their generic semaglutide pass muster with the FDA, CNBC TV18 reported Monday. First-to-file generics get a half a year of market exclusivity over their copycat rivals under FDA rules.
Over in India, Natco is preparing for a potential launch of semaglutide generics starting in March 2026, the news outlet added.
Novo has long been harangued by the media and lawmakers over the high price of its semaglutide-based drugs in the U.S. The fracas resulted in the company’s CEO, Lars Fruergaard Jørgensen, testifying before the Senate Health, Education, Labor and Pensions Committee last month.
Beyond the ability of generics to cut costs, Ozempic is also “very likely” to wind up on the negotiating table during the next round of price talks under the Inflation Reduction Act, Novo’s senior vice president of finance and operations, Ulrich Otte, said at the Cantor Global Healthcare Conference last month.