FDA's compounding allowance for semaglutide expires
The FDA's shortage-era permission for pharmacies to compound copies of Ozempic and Wegovy ended May 22, yet Novo Nordisk says copycat sales kept going "under the false guise of 'personalisation.'" [1]
The temporary arrangement that let US pharmacies make compounded copies of semaglutide — the active ingredient in Novo Nordisk's Ozempic and Wegovy — expired on May 22 [1]. Months later, the Danish drugmaker said sales of copycat versions were still going on "under the false guise of 'personalisation'" [1].
The allowance existed in the first place because Novo Nordisk could not make enough of the drug. The company's limited production capacity led the US Food and Drug Administration to temporarily permit pharmacies to create so-called "compound" or copycat versions of Ozempic and Wegovy [1]. That window has now closed [1].
What has not closed, according to Novo Nordisk, is the market itself. The company said last month that sales of generic versions of its treatments were continuing under a personalization rationale it disputes [1]. The details of how large that market is, which sellers are involved, or what enforcement steps regulators have taken are not described in the available reporting, so those specifics are not yet known from this source.
A harder market for the company
The compounding fight is one piece of a broader squeeze on Novo Nordisk. On September 10, the company announced it would cut 9,000 jobs — 11 percent of its workforce — including 5,000 in Denmark, saving eight billion kroner, or about $1.3 billion [1].
It also lowered its earnings forecast for the third time in 2025, now expecting operating profit growth of between four and 10 percent, down from 10 to 16 percent [1]. Investors reacted well to the restructuring news: the share price rose more than three percent in midday Copenhagen trading [1].
The company framed the cuts as a "company-wide transformation to simplify its organisation, improve the speed of decision-making, and reallocate resources towards the company's growth opportunities in diabetes and obesity" [1]. Chief executive Mike Doustdar, who succeeded Lars Fruergaard Jorgensen in August, said: "Our markets are evolving, particularly in obesity, as it has become more competitive and consumer-driven. Our company must evolve as well" [1].
That is a sharp turn from the boom years. Novo Nordisk's workforce grew from 43,700 in 2020 to 78,400 today, and the company was at one point Europe's most valuable, with its success credited for boosting Denmark's economic growth in 2023 [1]. Its share price has been falling since last year as sales slowed and competition grew from rival treatments in the United States, its key market — chiefly from Eli Lilly [1].
"Analysts say management underestimated emerging competition and misjudged its own market position," said Jochen Stanzl, chief market analyst at CMC Markets [1].
Why it matters for patients
During the shortage period, compounded semaglutide became a common workaround for people who could not get, or could not afford, the branded products. With the FDA allowance expired as of May 22 [1], the legal footing for those copies has changed, even though Novo Nordisk says sales have continued under a "personalisation" label [1].
For anyone weighing options, the practical point is that a product sold today as compounded or "personalized" semaglutide is not operating under the same shortage-period permission that applied before May 22 [1]. The sources here do not describe how compounded versions compare to branded Ozempic or Wegovy on purity, dosing accuracy or safety, so those comparisons are not established by this reporting.
On the supply side, Novo Nordisk says its restructuring reflects a "commitment to meet rising global demand" while competing in a more consumer-driven obesity market [1]. Whether that translates into steadier availability or different pricing is not addressed in the source.
What happens next
The key dated milestones so far: the compounding authorization lapsed May 22 [1]; Novo Nordisk raised the "personalisation" complaint in August [1]; and the 9,000-job restructuring was announced September 10 [1]. No further regulatory deadlines are described in the available reporting.
Sources
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