Novo Nordisk's Oral Wegovy Approved in U.S. as 2026 Fight Begins

Novo Nordisk enters 2026 facing what one analyst called a "must-win" year, after the Danish drugmaker secured U.S. approval for its oral version of Wegovy in late December 2025, sending shares up nearly 10%.

A pivotal U.S. approval

Novo Nordisk announced in late December 2025 that its new pill under the Wegovy brand had been approved in the United States, making it the first oral GLP-1 authorized in that market for weight management. The decision followed what Sydbank analyst Søren Løntoft Hansen described to CNBC as a year in which Novo's stock experienced its worst annual performance since it began trading on the Copenhagen exchange more than three decades ago.

Head-to-head with Eli Lilly

Eli Lilly is expected to receive a U.S. FDA decision on its own oral GLP-1, orforglipron, no later than the second quarter of 2026. Trial data reported by CNBC showed the oral Wegovy produced an average 16.6% body-weight reduction over 64 weeks, compared with 12.4% over 72 weeks for orforglipron.

Novo CEO Mike Doustdar told CNBC in November that "Wegovy in a pill basically will have the same efficacy as its injectable counterpart. That's really exciting". Novo also filed in late November for U.S. approval of a higher-dose 7.2 mg Wegovy injection, with trials showing an average 20.7% weight reduction.

Canadian context: generics reshape the market

The pill approval arrives as Novo's Canadian franchise contends with newly launched generic competition. Health Canada has approved two generic semaglutide injections — from Dr. Reddy's Laboratories and Apotex — making Canada only the second country in the world to clear a generic form of the molecule after Novo Nordisk did not pay a C$250 annual fee. Seven additional applications remain under review.

Dr. Reddy's version became available in Canada on May 15, while the Apotex product began shipping later. In response, Novo Nordisk Canada announced that eligible Canadians without public or private coverage could purchase brand-name Ozempic at a reduced price via a Novo Nordisk Savings Card, applied automatically at Novo Nordisk Care Rx operated by Rexall, and available at pharmacies across Canada excluding Quebec.

Iain Graham, general manager at Novo Nordisk Canada, said the company is "dedicated to ensuring that eligible patients who choose Ozempic can stay on the brand because of these additional savings". Global News reported brand-name Ozempic and Wegovy currently cost hundreds of dollars per month depending on dosage, in some cases more than $450. Current pharmacy prices tracked by GLP1Prices.ca range from C$86.40 to C$663 for Ozempic and C$270 to C$550 for Wegovy, consistent with that reporting.

The direct-to-consumer front

CNBC reported that in November the Trump administration reached a deal with Novo Nordisk and Eli Lilly to lower prices on their GLP-1 medicines under Medicare and Medicaid, and to offer them to consumers at a discount through the TrumpRx.gov website, which was set to launch in January 2026.

Morningstar analyst Karen Andersen told CNBC that "the TrumpRx deal will help Novo become more competitive with compounders on price, although a faster orforglipron launch could reduce its ability to gain momentum in the [direct-to-patient] channel ahead of Lilly". She added that oral GLP-1 drugs "will be even better suited to this channel".

Sydbank's Hansen summarized the year ahead bluntly: "The marketable development for Wegovy and Ozempic is a must-win battle for [CEO] Mike Doustdar and the new board".

Canadian shoppers comparing options can review our generic semaglutide tracker, the insurance coverage checker, and pricing pages for Mounjaro, Zepbound and Rybelsus, or consult the FAQ for more context.

This article is for informational purposes only and does not constitute medical advice.

Sources

• Novo Nordisk faces 'must-win' battle over U.S. Wegovy ...
• Ozempic generic approved in Canada after Novo Nordisk ...
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