Novo Nordisk has received notifications from several manufacturers that they have filed Abbreviated New Drug Applications (ANDAs) for liraglutide, the active pharmaceutical molecule in Victoza® and in Saxenda®, respectively, and semaglutide, the active pharmaceutical molecule in Ozempic® and in Rybelsus®, respectively, with the FDA. The ANDAs contain Paragraph IV certifications to obtain approval to engage in the commercial manufacture, use, or sale of such products before the expiration of some or all of the patents currently listed for those products in the Orange Book. Novo Nordisk has filed complaints for patent infringement against these manufacturers. Novo Nordisk does not expect these matters to have a material impact on Novo Nordisk's financial position, operating profit or cash flow.

Novo Nordisk has entered into settlement agreements with several manufacturers that have filed ANDAs for Victoza®. Consequently, these manufacturers are licensed to launch a generic version of Victoza® as of 22 June 2024, or earlier under certain circumstances. Moreover, Novo Nordisk has entered into a settlement agreement with Teva Pharmaceuticals USA, Inc., regarding the US patent litigation case for Saxenda®. All terms of the agreement are confidential. All agreements are subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.

1,Novo Nordisk.