Novo Nordisk A/S (Novo Nordisk) operates as a global healthcare company. The company manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.
The company has a broad product portfolio across Diabetes and Obesity care and Rare disease, including a portfolio of glucagon-like-peptide-1 (GLP-1) receptor agonists for the treatment of diabetes and obesity, modern insulins and human insulins. During 2024, there ha...
Novo Nordisk A/S (Novo Nordisk) operates as a global healthcare company. The company manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.
The company has a broad product portfolio across Diabetes and Obesity care and Rare disease, including a portfolio of glucagon-like-peptide-1 (GLP-1) receptor agonists for the treatment of diabetes and obesity, modern insulins and human insulins. During 2024, there has been continued strong growth across therapy areas and geographic areas in which Novo Nordisk operates.
High demand during 2024 has led to periodic supply constraints for certain products in some markets, including the leading product by sales, Ozempic for the treatment of type 2 diabetes1. The company also markets two drugs - Saxenda and Wegovy - for the treatment of obesity. Further, Novo Nordisk has a Rare disease portfolio consisting mainly of growth hormone and haemophilia products.
On December 18, 2024, Novo Nordisk acquired three fill-finish sites from Novo Holdings A/S in connection with a transaction where Novo Holdings A/S acquired Catalent, Inc. (‘Catalent’), a global contract development and manufacturing organisation. The acquisition of the fill-finish sites is aligned with Novo Nordisk’s strategy of reaching more people living with diabetes and obesity with current and future treatments. It is expected to enable an expansion of the manufacturing capacity and provide future optionality and flexibility for Novo Nordisk’s existing supply network. The acquisition is expected to gradually increase Novo Nordisk's filling and finish capacity.
Segment information
The company engages in the discovery, development, manufacturing and marketing of pharmaceutical products and has two business segments: Diabetes and Obesity care; and Rare Disease.
Market
Novo Nordisk’s insulin and other pharmaceutical products are marketed and distributed through subsidiaries, distributors, and independent agents each responsible for specific geographic areas. The company’s financial reporting is divided into: EMEA (covering Europe, the Middle East, and Africa), Region China (covering Mainland China, Hong Kong, and Taiwan), Rest of World (covering all other countries except for North America) and North America (covering the United States and Canada).
Several of the major international pharmaceutical companies have entered the diabetes market, specifically in the area of oral products for the treatment of type 2 diabetes.
In February 2018, Novo Nordisk launched the once-weekly GLP-1 product, Ozempic, for the treatment of adults with type 2 diabetes in the United States and Canada. Since then, Ozempic has become a market leading product and the company's best performing product by sales.
Wegovy has been launched in the United States and more than 15 other countries outside the United States.
Patent situation of key Diabetes and Obesity care products
Novo Nordisk has received notifications from several manufacturers that they have filed Abbreviated New Drug Applications (ANDAs) for generic versions of Victoza, Saxenda, Ozempic, Wegovy, and Rybelsus, respectively. 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 filed complaints for patent infringement against these manufacturers.
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 June 22, 2024. Teva launched an authorized generic version of Victoza in June, 2024, and Hikma Pharmaceuticals PLC launched its generic liraglutide product in December 2024. Moreover, Novo Nordisk has entered into settlement agreements regarding the U.S. patent litigation matters for Saxenda. Novo Nordisk has also entered into a settlement agreement with Alvogen Inc., Rio Biopharmaceuticals Inc., Sun Pharmaceutical Industries Limited, Dr. Reddy’s Laboratories, Ltd., Mylan Pharmaceuticals Inc., Zydus Pharmaceuticals Inc., and Apotex Inc. regarding the U.S. patent litigation for Ozempic. All terms of the agreements are confidential. All agreements are subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
In March 2023, Mylan filed IPR challenging the validity of a patent which claims a method of treating type 2 diabetes using 1 mg of semaglutide, and the Patent Trial and Appeal Board instituted an IPR proceeding. After the institution decision, Sun, DRL, and Apotex moved to join the IPR and those motions were granted. In October 2024, Novo Nordisk settled with Mylan, Sun, DRL, and Apotex prior to the IPR hearing. All terms of the agreements are confidential. All agreements are subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
In China, the semaglutide compound patent was subject to invalidation actions and was upheld by the Beijing IP Court in November 2023. This decision has been appealed to the Supreme People's Court where the case is pending.
Novo Nordisk will continue to defend its intellectual property associated with liraglutide and semaglutide, including through litigation.
Compound patent expiry in the U.S. for the semaglutide branded products - Ozempic, Rybelsus, and Wegovy - is 2032.
Regulation
As a pharmaceutical company, Novo Nordisk depends on government approvals related to production, development, marketing and reimbursement of its products. Important regulatory bodies include the U.S. Food and Drug Administration, the European Medicines Agency, China's National Medical Products Administration and the Japanese Ministry of Health, Labour and Welfare. Treatment guidelines from non-governmental organizations such as the European Association for the Study of Diabetes and the American Diabetes Association may also impact the company.
History
Novo Nordisk A/S was founded in 1923.