Novo warns that 1.5 million US patients still use compounded GLP-1s

Novo Nordisk has estimated that as many as 1.5 million patients in the United States are still using lower-cost compounded versions of GLP-1 medicines, a habit that took hold during earlier supply shortages of Ozempic and Wegovy ^[1]. The company disclosed the figure as it works to win back patients who turned to compounding pharmacies when brand-name semaglutide was hard to find.

The US Food and Drug Administration has declared the shortage over, which in principle ends the legal pathway that let compounders make copies of approved drugs during shortages ^[1]. Even so, compounding pharmacies have kept selling customized versions by adjusting doses or adding ingredients such as vitamin B12, according to the report ^[1]. Novo's disclosure came alongside broader signs of pressure on its business: sales of Eli Lilly's Zepbound, a tirzepatide drug launched in 2023, surpassed Wegovy in dollar terms last year, and analyst consensus compiled by Bloomberg suggests that lead could stretch into 2026 ^[1]. Novo has separately warned that its overall sales will decline this year ^[1].

Pricing has become a central battleground. In November, Novo and Lilly agreed with the Trump administration to lower prices for their leading weight-loss injections under Medicaid and Medicare, and direct-to-consumer prices for Ozempic and Wegovy are set to fall as part of that arrangement ^[1]. Novo has said the lower prices could weigh on global sales growth this year, even though the deal also secures a fast-tracked FDA review for a higher-dose Wegovy and a three-year exemption from US tariffs on pharmaceutical imports ^[1]. Semaglutide patents are also beginning to expire in several countries, which could eventually open the door to broader generic competition ^[1].

Under Chief Executive Officer Mike Doustdar, who took over in August, Novo has cut jobs and prices while expanding NovoCare, its direct-to-patient US platform launched last March, to attract cash-paying customers who might otherwise turn to compounded alternatives ^[1]. In November, the company added deeper discounts for patients buying through NovoCare and partner services such as WeightWatchers ^[1]. Novo also moved first into oral obesity treatment, winning FDA approval ahead of Lilly and starting US sales of an oral version of Wegovy in January ^[1]. A cheaper copycat pill from Hims & Hers Health briefly reached the market less than a month later but was withdrawn after the FDA pledged to crack down on copycat weight-loss drugs ^[1].

Why it matters for patients

For patients who started on compounded semaglutide during the shortage, the landscape is shifting on two fronts at once: enforcement against compounders is tightening now that the FDA considers the shortage resolved, while brand-name manufacturers are cutting cash prices and building their own direct-sale channels to compete for the same customers ^[1]. That means the price gap between compounded and brand-name options, one of the main reasons patients chose compounding in the first place, may narrow, though the sources do not specify current cash prices under the new discounts. Patients relying on compounded products should be aware that the legal basis for those products is described as ending in principle, even though sales have continued ^[1].

What happens next

Novo is developing a higher-dose Wegovy that it says could match the weight-loss results of Zepbound, and it is advancing another drug, CagriSema, though a February study found CagriSema produced less weight loss than Lilly's tirzepatide in a head-to-head comparison ^[1]. The fast-tracked FDA review of the higher-dose Wegovy tied to the November pricing agreement was not given a specific date in the source material ^[1].