Novo Nordisk Expands Wegovy Portfolio Amid FDA Warning and Legal Challenges

Novo Nordisk has received FDA approval for an oral Wegovy pill for obesity and started its commercial launch in the U.S. in January 2026, while simultaneously facing regulatory scrutiny over advertising and pursuing legal action against compounded alternatives. The FDA has cited a Wegovy television advertisement as misleading and requested corrective action, adding regulatory scrutiny on how the new pill is promoted.

The oral Wegovy pill is a once-daily tablet available in 1.5mg, 4mg, 9mg and 25mg dosages. It is widely available in the U.S. for a starting cost of $149 per month and has seen strong initial uptake. Rapid early adoption of the new oral GLP-1 pill, with 170,000 patients reported within four weeks, shows clear demand for pill-based options. The pill formulation demonstrated about 17% weight loss, if all patients stayed on the treatment.

Novo Nordisk revealed plans to launch the drug in vials in the U.S. in 2026 to compete with Eli Lilly's vials, allowing for easier and potentially higher-volume manufacturing compared to pen devices. The company is exploring various device presentations for Wegovy, including vials - some are launching this year, others are coming in the future. The vial format allows patients who prefer injections to use the same medication without the need for oral administration.

The company has taken legal action against Hims & Hers over compounded versions of its Wegovy pill that do not have individual FDA approval. The FDA has moved to restrict unapproved compounded GLP-1 products, including versions referencing Wegovy, citing safety and quality concerns. Legal and regulatory actions against compounded semaglutide may reduce pressure from unapproved low cost alternatives and support the position of branded GLP-1 drugs.

Management is guiding for a 5% to 13% decline in 2026 sales and earnings, driven by U.S. price cuts on GLP-1 drugs, tougher payer negotiations and competition from copycat products. According to the company's 2025 full-year results released on 5 February 2026, sales increased by 10% to DKK 309.064bn ($49.086bn), driven by a 41% rise in Wegovy sales. However, Q4 saw a 2% sales decline and 4% lower operating profit. Net debt for the full year was reported at $15.155bn, following acquisitions.

Novo Nordisk has revealed plans to expand its production facility in Ireland to manufacture Wegovy, making the drug more accessible to patients beyond the U.S. market. The company's Athlone facility in Ireland will undergo expansion. The move forms part of Novo Nordisk's broader strategy to reclaim its position in the weight-loss market, where the pharmaceutical company has been competing since losing ground to rival Eli Lilly, the maker of injectable treatment Zepbound.

Wegovy was originally approved in June 2021 for chronic weight management in adults with obesity or overweight who have at least one related condition, such as hypertension, type 2 diabetes, or high cholesterol, alongside diet and exercise. In 2024, its label was further expanded to include adults with cardiovascular disease.

Meijer pharmacy locations will be providing these drugs at discounted out-of-pocket prices. Patients who are new to these coupon programs can access the two lowest-dose version of Wegovy or Ozempic injection pens for $199 per month during their first two months, as long as the prescriptions are filled by March 31, 2026. Following this promotional period, a majority of dose levels jump to $349 per month, while the highest Ozempic dose stands at $499 per month. The oral version of Wegovy is also an option—patients who qualify will be able to pay $149 per month, with insurance co-pays as low as $25.