India got it earlier this year, and Canada approved it last month. But when is the United States going to get a generic version of Ozempic?<\/p>\n
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Not this decade, experts say. <\/p>\n
Thanks largely to loopholes in the U.S. patent system, Americans aren\u2019t expected to get generic forms of semaglutide<\/a>, the drug in Novo Nordisk\u2019s Ozempic and Wegovy, until at least the end of 2031.<\/p>\n Even that timing is uncertain, said Arti K. Rai, a professor at the Duke University School of Law and former senior official in the United States Patent and Trademark Office. \u201cIt could take much, much longer than that.\u201d<\/p>\n The appeal of a generic Ozempic is simple: Generic versions of drugs are typically much cheaper than the original brand-name medications.<\/p>\n 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<\/a>, but many patients still struggle to afford the drug without insurance. Following public outcry, the drugmaker announced it will slash Ozempic\u2019s and Wegovy\u2019s monthly list prices<\/a> to $675 starting next year.<\/p>\n The high cost has helped fuel a boom in compounded semaglutide products<\/a> \u2014 lower-cost, copycat versions of Ozempic and Wegovy made by compound pharmacists. But the products are not considered true generics because they haven\u2019t been reviewed or approved by the Food and Drug Administration for safety or effectiveness. The FDA has increasingly cracked down on them and has proposed limits<\/a> on how much compounding pharmacists can produce.<\/p>\n Outside the U.S., approved generic versions of semaglutide are beginning to hit the market. India and Canada recently approved their first generic versions of Ozempic, and countries including China, Brazil and South Africa are expected to soon follow, according to Robin Feldman, a pharmaceutical and intellectual property law expert at the University of California Law San Francisco.<\/p>\n In other countries, \u201cthe GLP-1 market is facing a shakeout in 2026,\u201d Feldman said. <\/p>\n The U.S., however, remains on a very different timeline.<\/p>\n Evergreening<\/strong><\/p>\n The standard length of a drug patent<\/a> in the U.S. is 20 years from the filing date. Novo Nordisk first applied for a U.S. patent on semaglutide in 2006<\/a>. Due to patent extensions, approved generic versions of semaglutide aren\u2019t expected in the U.S. until at least the end of 2031.<\/p>\n Rai said the additional five years, stretching the patent from 2026 to 2031, likely stem from the Hatch-Waxman Act, a 1984 law that allows drugmakers to extend patents by up to five years to make up for time lost moving their drug through clinical trials and the FDA approval process. <\/p>\n Rai said patent lawyers for the pharmaceutical industry didn\u2019t initially use the law much, but around 2010 its use \u201cbegan to increase dramatically.\u201d<\/p>\n It\u2019s now commonly used by many drug companies to extend their patents, Feldman said.<\/p>\n Then come secondary patents. <\/p>\n \u201cWhen people think of a drug patent, they usually think whatever the molecule is should be the subject of the patent,\u201d Rai said. \u201cBut the conventional strategy is to seek, on assets as lucrative as Ozempic, dozens more patents, and that\u2019s what they\u2019ve done.\u201d<\/p>\n Drugmakers often file additional, secondary patents \u2014 a tactic known as evergreening \u2014 to extend their monopoly on their product and delay generics. The additional patents can include new doses, formulations or delivery devices.<\/p>\n \u201cUnfortunately, the U.S. has been much more receptive to efforts to \u2018evergreen\u2019 patent life by adding follow-on patents,\u201d said Mark Lemley, a professor at Stanford Law School who teaches intellectual property and patent law. <\/p>\n Feldman said the patents for semaglutide \u201crange from those related to the chemical molecules; methods of use for treating different indications, including diabetes, weight loss, heart disease and others; and device patents for the delivery mechanisms.\u201d <\/p>\n