The Danish pharmaceutical company Novo Nordisk, a leader in the global obesity treatment market, has resolved supply shortage issues and has emerged from sanctions imposed by the U.S. Food and Drug Administration (FDA) after two and a half years. As competitor Eli Lilly in the U.S. has worked to reclaim its position in the market by addressing supply risks, competition for dominance in the global obesity drug market is expected to intensify.
On the 21st (local time), the FDA announced that Novo Nordisk had resolved supply shortages of its obesity drug Wegovy, which contains the active ingredient semaglutide, and the type 2 diabetes treatment Ozempic. These medications have also been removed from the FDA’s 'drug shortage lists,' which classify and manage drugs unable to keep up with surging demand.
Wegovy was added to this list in April last year, following the diabetes treatment Ozempic, which uses the same active ingredient and was approved in August 2022. Wegovy is an obesity treatment that was approved by the FDA in June 2021 and currently holds approximately 74% of the global obesity treatment market.
The competing drug, Eli Lilly's Zepbound (active ingredient tirzepatide), is a latecomer that was approved two years later, in November 2023. In South Korea, it is set to launch under the product name 'Mountzaro' in May. Zepbound was also included in the drug shortage list in the same month as Wegovy but was quickly able to ramp up production and was removed from the list in October of last year.
For those medications listed, the FDA allows compounding pharmacies or small pharmaceutical companies to create and sell combination products with the same active ingredient.
Wegovy is not covered by public insurance in the U.S., leading to a significant cost burden for patients. The local price of Wegovy is approximately $1,000 (1.41 million won) for a monthly prescription. Consequently, there has been a significant rise in consumers seeking generic drugs in the U.S. As of July last year, it was reported that 2 million Americans were using generic versions of obesity medications, including Wegovy.
For these reasons, there are projections that Eli Lilly may reclaim the top spot that Wegovy has held in the global obesity drug market for the past three years. According to Reuters, it was reported that in early March last year, the number of new prescriptions for Zepbound in the U.S. surpassed those for Wegovy for the first time. Experts estimated that by August last year, Zepbound held a 40% share of the U.S. obesity drug market, closely following Wegovy.
In addition, the results of clinical trials comparing the weight loss efficacy of Wegovy and Zepbound showed that Zepbound was 47% more effective than Wegovy, which is expected to negatively impact Wegovy's market share.
In response, Novo Nordisk focused all efforts on increasing production to exit the FDA’s drug shortage list. It is reported that the company invested over $7.09 billion (10.3 trillion won) in facility expansions over the past year.
On this day, Novo Nordisk stated in a press release, "The company is operating its production facilities 24/7 to keep up with Wegovy demand," and explained, "We have invested billions of dollars in increasing production capacity over the past several years."
The company emphasized that the production and sale of generic drugs for Wegovy and Ozempic would be considered illegal. Dave Moore, vice president for global business development at Novo Nordisk, noted, "Combining and manufacturing or selling Ozempic and Wegovy will become illegal under the law," and added, "No one should have to rely on fake or illegal generic drugs that could harm health and pose serious safety risks to patients due to misinformation."