Novo Nordisk has landed an approval from the US Food and Drug Administration (FDA) for a high dose version of its best-selling weight loss drug, Wegovy (semaglutide), as patents covering the therapy’s market exclusivity edge closer to expiry in certain locations.
The FDA authorisation means that the 7.2mg option, which Novo is marketing as Wegovy HD, will become available to American patients in April 2026. Wegovy HD is suitable for use as a weight loss and maintenance therapy in patients with obesity or overweight with at least one weight-related comorbidity.
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The therapy’s approval was based on clinical data from the STEP UP trial programme, in which a 7.2mg dose of Wegovy triggered additional weight loss over previously approved doses in patients with obesity (NCT05646706), while maintaining a similar safety profile.
Wegovy HD’s regulatory go-ahead came just one day before the 20 March expiry date for patents covering semaglutide – Wegovy’s active ingredient – in India and China. Now that Wegovy is officially off-patent in India, at least 12 large manufacturers are looking to debut their copycat drugs on this market, with Natco Pharma planning to sell its semaglutide biosimilar for as cheap as $14 a month, as per a Bloomberg article. Currently, a month’s worth of Wegovy costs anything between $108-$173 in India.
Chinese drugmakers are also looking to capitalise on Wegovy’s patent expiry, with 16 biosimilars for the drug currently in development across China. This includes United Laboratories’ semaglutide dupe, which is currently in Phase III trials for obesity and the pre-registration phase for type 2 diabetes.
Meanwhile, Sandoz is eyeing the Canadian market with its Ozempic (semaglutide) copy, which could reach the type 2 diabetes market by Q2 2026, the company’s CEO, Richard Saynor said in November 2025.
CNPV programme yields another approval
Upon its market approval, Wegovy HD has become the fourth drug to secure an FDA nod under the Commissioner’s National Priority Voucher (CNPV) pilot programme. This framework allows companies to access quicker review times for their drugs – provided they address unmet needs, enhance treatment affordability, offer as a cure or boost manufacturing on American soil.
The FDA has already awarded CNPVs to several companies, including Merck, Regeneron, Sanofi, Revolution and Dompé Farmaceutici – with the scheme falling under Trump’s continued efforts to enhance the development of drugs for Americans.
Most recently, Johnson & Johnson’s multiple myeloma combination, Tecvayli (teclistamab)-Darzalex Faspro (daratumumab) secured the FDA greenlight under the CNPV scheme.
Since the regulatory framework’s debut, however, pharma industry members have raised questions about how voucher awardees are selected.
