The World Health Organisation (WHO) has updated its model list of essential medicines (EML) to include four key and drugs.
This includes Novo Nordisk鈥檚 semaglutide, marketed as Ozempic and Wegovy for T2D and weight management, respectively, as well as Eli Lilly鈥檚 tirzepatide, marketed as Mounjaro and Zepbound, again in T2D and weight management, respectively.
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The United Nations (UN) agency has added the glucagon-like peptide-1 receptor agonists (GLP-1RAs) and dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists to the EML following a review from the WHO Expert Committee, which found 鈥渟trong scientific evidence鈥� to support their benefits in patients with T2D.
However, WHO raised concerns about the costs of both semaglutide and tirzepatide, which come with a hefty price tag of between $997 and $1349 for a one-month prescription in the US, which the agency warns could complicate patient accessibility.
Both Lilly鈥檚 Trulicity (dulaglutide) and Novo Nordisk鈥檚 Saxenda (liraglutide) are also on the list. Saxenda is currently very similar in price to its more efficacious successor, semaglutide. Meanwhile, Trulicity also offers only a small price reduction, being sold at $987 instead of the $1079.77 charge for Mounjaro.
To promote accessibility to these drugs for all patients worldwide, the WHO has called for their uptake in global primary care systems, while encouraging the development of cheaper generic alternatives to drive down costs.
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By GlobalData鈥淭his designation is likely to transform the overall obesity, diabetes and cardiovascular disease market by increasing demand, driving price reductions via generic competition, and expanding usage beyond affluent populations,鈥� said Valentina Gburcik, senior director of cardiovascular and metabolic disorders at GlobalData.
Gburcik also noted that the move could 鈥渟hift market focus toward broader primary care indications rather than niche or elite populations鈥�, while it may also encourage pharmaceutical manufacturers to accelerate global regulatory approvals and distribution efforts.
Generics to improve GLP-1RA accessibility
The August 2025 US approval of Teva Pharmaceutical鈥檚 generic Saxenda has left Novo Nordisk鈥檚 version vulnerable to competition.
According to Gburcik, liraglutide鈥檚 EML listing will 鈥渙nly accelerate Saxenda鈥檚 market share erosion by stimulating generic manufacturing,鈥� though the move could also potentially 鈥渋ncrease total sales volume at lower prices鈥�.
This has led analysts at GlobalData, parent company of Pharmaceutical Technology, to forecast that Saxenda will make just $135m in 2031 鈥� down 91% from the $1.5bn sales seen at its peak in 2022.
Meanwhile, semaglutide鈥檚 patent expiry is set to be another thorn in Novo Nordisk鈥檚 side, as the Danish pharma鈥檚 best-selling drug will face generic competition in 2026 in India, China, Brazil, Canada and Turkey.
Though its patent in the key US market is not due to expire until the early 2030s, generics will soon be permitted in these markets. Chinese drug manufacturers are now looking to jump on the GLP-1RA bandwagon, preparing their semaglutide generics ready for next year鈥檚 patent cliff.
Semaglutide鈥檚 global sales stood at DKr178.2bn ($28bn) in 2024.
Eli Lilly鈥檚 Trulicity patent is set to expire in 2027, while the patent for the tirzepatide鈥痬olecule will expire in 2036 in the US, but active formulation patents may extend the exclusivity for Eli Lilly’s Mounjaro and Zepbound until around 2039.
