Novo Nordisk secures FDA approval for high-dose wegovy as patent expiry looms

USA—Novo Nordisk has obtained FDA approval for a high-dose version of its blockbuster weight-loss drug, Wegovy (semaglutide), marking a strategic move as the therapy’s patent protection expires in key markets worldwide.

The FDA authorization clears the way for the 7.2 mg formulation, branded as Wegovy HD, to reach American patients in April 2026.

Healthcare providers can prescribe the treatment for weight loss and maintenance in patients with obesity or those who are overweight with at least one weight-related health condition.

Clinical evidence supporting approval came from the STEP UP trial programme, in which the 7.2 mg dose demonstrated greater weight reduction than previously approved doses in patients with obesity.

The higher-strength formulation maintained a safety profile similar to that of existing formulations, according to trial data.

Patent expiry triggers biosimilar race

The regulatory approval arrived just one day before semaglutide patents expired in India and China on March 20.

This timing has unleashed significant competition in these markets, with at least 12 major Indian manufacturers preparing to launch copycat versions of the drug.

Natco Pharma plans to offer its semaglutide biosimilar at approximately USD14 per month in India, drastically undercutting current prices that range from USD108 to USD173 (₹9,000 to ₹14,400) per month.

Chinese pharmaceutical companies are equally aggressive, with 16 biosimilar candidates currently in development across the country.

United Laboratories has advanced its semaglutide biosimilar to Phase III trials for obesity treatment while simultaneously pursuing pre-registration approval for type 2 diabetes.

Meanwhile, Sandoz is targeting the Canadian market with its Ozempic (semaglutide) copy, which CEO Richard Saynor indicated could launch for type 2 diabetes by the second quarter of 2026.

Fast-track approval under Trump-era programme

Wegovy HD became the fourth drug to receive FDA approval through the Commissioner’s National Priority Voucher pilot programme.

This framework provides expedited review timelines for therapies that address unmet medical needs, improve treatment affordability, provide curative options, or strengthen domestic manufacturing capabilities.

The FDA has distributed CNPVs to multiple pharmaceutical companies, including Merck, Regeneron, Sanofi, Revolution, and Dompé Farmaceutici.

The initiative aligns with the Trump administration’s broader push to accelerate drug development for American patients.

Johnson & Johnson recently received CNPV approval for its multiple myeloma combination therapy, Tecvayli (teclistamab)-Darzalex Faspro (daratumumab).

However, pharmaceutical industry stakeholders have raised concerns about the transparency and criteria used to select voucher recipients since the programme’s launch.

The approval positions Novo Nordisk to maintain market presence in the United States while facing mounting biosimilar pressure in international territories where patent protections have lapsed.