Novo Nordisk pegs US compounded GLP-1 use at up to 1.5 million people
The estimate suggests a large number of US GLP-1 users still buy compounded copies, even after the FDA declared the shortage over and Novo began cutting cash prices.
Novo Nordisk has estimated that as many as 1.5 million people in the United States are using compounded versions of GLP-1 drugs, a cheaper alternative that many patients turned to while supplies were tight [1]. The company has paired that figure with stepped-up enforcement and a cash-price strategy aimed at winning those customers back [1].
Novo sells semaglutide under the brand names Ozempic, Wegovy and Rybelsus. Eli Lilly's rival molecule, tirzepatide, is sold as Mounjaro and Zepbound [1].
A market that outlasted the shortage
Compounded products are custom-made copies rather than approved brand-name drugs. The FDA has declared the GLP-1 shortage over, a step that on paper ends the pathway compounders used to sell such copies [1]. Even so, some compounders have kept selling versions with adjusted doses or added ingredients such as vitamin B12 [1].
How Novo arrived at the 1.5 million figure has not been disclosed, and neither has the split between compounded semaglutide and compounded tirzepatide [1].
Price cuts and policy
Since Mike Doustdar became chief executive in August, Novo has reduced jobs and prices [1]. The company has also built out NovoCare, a direct-to-patient US platform launched last March to reach cash-paying customers who might otherwise buy a compounded copy, and in November it announced deeper discounts for patients buying through NovoCare and partner services including WeightWatchers [1].
Policy is moving prices as well. President Donald Trump has pushed for lower US drug prices and for aligning them with other developed markets [1]. In November, Novo and Lilly agreed with the administration to cut prices on their leading weight-loss injections for Medicaid and Medicare, and direct-to-consumer prices for Ozempic and Wegovy are set to fall under that arrangement [1].
Competition is the other source of pressure. A head-to-head trial found Lilly's Zepbound, introduced in 2023, produced greater weight loss than Wegovy, and Zepbound's sales passed Wegovy's in dollar terms last year; an analyst consensus compiled by Bloomberg points to that lead extending into 2026 [1]. Novo has warned that its overall sales will decline this year as prices come down [1]. Semaglutide patents are also beginning to expire in several countries, which could open the door to broader generic competition [1].
Why it matters for patients
Cost and availability are the practical questions for anyone choosing between a brand-name GLP-1 and a compounded version. Compounded copies are cheaper, and the NovoCare discounts are designed to narrow that difference [1]. The November agreement also lowers what people covered by Medicaid and Medicare pay for the leading weight-loss injections [1].
Availability of compounded copies has been uneven. The FDA's shortage declaration formally closes the compounding pathway, yet some compounders have continued selling dose-adjusted versions [1]. Whether compounded products are tested the same way as approved drugs, or can be substituted for them, has not been reported [1]. It is also not known how many of the 1.5 million patients use compounded semaglutide rather than compounded tirzepatide [1].
What happens next
Under the November arrangement, direct-to-consumer prices for Ozempic and Wegovy are expected to drop, and Novo gains a fast-tracked FDA review of a higher-dose Wegovy plus a three-year exemption from US tariffs on imported pharmaceuticals [1].
Novo began selling an oral version of Wegovy in the US in January, after receiving FDA approval ahead of Lilly [1]. A cheaper copycat pill from Hims & Hers Health entered the market less than a month later and was withdrawn after the FDA pledged to crack down on copycat weight-loss drugs [1]. Novo is also developing a higher-dose Wegovy it says offers the same weight-loss potential as Zepbound, and advancing CagriSema, though in February the company reported that CagriSema delivered less weight loss than Lilly's tirzepatide in a head-to-head study [1].
Sources
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