Mylan and Novo Nordisk Settle Ozempic Patent Dispute, Paving Way for Semaglutide Biosimilar Development

India's Natco Pharma said in a filing on the National Stock Exchange of India on Monday that Mylan Pharmaceuticals (now part of Viatris) and Novo Nordisk had reached a settlement in the patent litigation over Ozempic (semaglutide). Natco stated that the terms of the settlement are confidential. Natco explained in the filing that it is collaborating with Mylan to develop a generic version of Ozempic, with Indian CDMO Stelis Biopharma engaged as the production partner, and relevant agreements have been signed.

After media inquiries, a spokesperson for Novo Nordisk confirmed in an email that a settlement had been reached with Mylan. However, Viatris did not immediately respond to related topics.

Since January 2023, Novo Nordisk has filed lawsuits at least twice against Mylan's efforts to advance the production, market launch, and sales of semaglutide generics. It is currently known that two of the lawsuits specifically involve Wegovy, while the settlement announced on Monday only pertains to the type 2 diabetes drug Ozempic.

According to financial data disclosed by Novo Nordisk, Ozempic's sales last year were approximately $14 billion, while Wegovy's sales for the whole year of 2023 were about $4.5 billion. While Novo Nordisk is reaping huge profits from its GLP-1 projects, the Sword of Damocles will fall within the next decade. In its 2023 annual report, Novo Nordisk mentioned that Ozempic and Wegovy will begin to lose patent protection in the United States in 2032.

With the settlement agreement reached, Mylan and Natco may have a significant advantage in the competition for generic versions of Novo Nordisk's blockbuster diabetes drug.

According to a report by CNBC TV18 on Monday, Natco has the priority application rights for certain doses of Ozempic and all doses of Wegovy. If their generic versions pass the review of the U.S. Food and Drug Administration (FDA), Natco and its partner Mylan may gain a significant market advantage. According to FDA regulations, the first generic drug to be submitted for marketing and receive approval can obtain an additional six months of market exclusivity over its generic competitors.

Of course, the problems faced by Novo Nordisk are not only the impact of patent cliffs and generic drugs. For a long time, Novo Nordisk has been fiercely criticized by the media and members of Congress for the high price of semaglutide drugs produced in the United States. This controversy led to the company's CEO, Lars Fruergaard Jørgensen, attending a hearing at the Senate Health, Education, Labor, and Pensions Committee last month.

At the same time, Novo Nordisk's Senior Vice President of Finance and Operations, Ulrich Otte, said at last month's Cantor Global Healthcare Conference that, in addition to the cost-reducing advantages of generic drugs, Ozempic is also "very likely" to appear on the negotiating table during the next round of price negotiations under the Inflation Reduction Act. However, based on the prices from the first round of negotiations, a new round of impacts may be imminent.

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