Generic versions of Novo Nordisk's Ozempic are not expected to be available in the United States until at least the end of 2031, according to patent experts. Novo Nordisk first applied for a U.S. patent on semaglutide, the active ingredient in Ozempic, in 2006.
The standard length of a drug patent in the U.S. is 20 years from the filing date. Under the Hatch-Waxman Act, a 1984 law, drugmakers can extend patents by up to five years to make up for time lost during clinical trials and the Food and Drug Administration approval process. Patent lawyers began increasing their use of that law around 2010. Drugmakers also often file additional secondary patents, a tactic known as evergreening, to extend their monopoly on their products.
"It could take much, much longer than that," said Arti K. Rai, a professor at the Duke University School of Law and a former senior official in the United States Patent and Trademark Office, referring to the timeline for U.S. generics.
Ozempic can cost close to $1,000 a month in the United States. Novo Nordisk recently introduced a lower cash price of $349 a month for the drug, and the company announced it will reduce the monthly list prices of Ozempic and Wegovy to $675 starting next year.
Other countries have moved faster on generics. India approved its first generic version of Ozempic earlier this year, and Canada approved its first generic version last month. China, Brazil and South Africa are expected to soon approve generic versions as well.
In the U.S., compounded semaglutide products, lower-cost copycat versions of Ozempic and Wegovy made by compound pharmacists, have filled part of the gap. Those products have not been reviewed or approved by the FDA for safety or effectiveness. The FDA has proposed limits on how much semaglutide compound pharmacists can produce. "The GLP-1 market is facing a shakeout in 2026," said Robin Feldman, a pharmaceutical and intellectual property law expert at the University of California Law San Francisco.
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