Semaglutide patents lapse in China and Brazil

Novo Nordisk's core compound patent on semaglutide — the active ingredient in Ozempic, Wegovy and Rybelsus — officially expired in China on March 20, 2026 ^[4]. Brazil's core patent stems from the same 2006 international filing and also runs out in 2026, along with patents in India and a Canadian patent that was allowed to lapse ^[2].

Analysts at IQVIA count eight markets in this "first wave" of lost exclusivity: Canada, Brazil, China, India, Mexico, Turkey, Saudi Arabia and South Africa ^[1]. Together, those countries account for 38% of the world's adults living with obesity, meaning more than one in three people with obesity will live somewhere with off-patent semaglutide ^[1]. About a quarter of the world's population with obesity lives in India and China alone ^[2].

How the first wave is playing out

The rules differ sharply by country. Canada and Saudi Arabia treat semaglutide as a chemical drug requiring only bioequivalence studies; Brazil, India and South Africa classify it as a biologic, with Brazil requiring impurity, aggregate and immunogenicity testing for synthetic versions ^[1]. China takes a mixed approach — biologic if made by recombinant methods, chemical drug if synthetic — but requires full clinical studies either way ^[1].

In China, 12 domestic semaglutide copies from 10 companies had registration applications filed as of March 2026, with the first approvals speculated as early as the third quarter of 2026 ^[4]. Prices there have already fallen: a 1.34 mg/mL, 1.5 mL prefilled pen went from 1,120 yuan to 478.8 yuan, and a 2.27 mg/mL, 3 mL pen used for weight management dropped from 1,893.67 yuan to 987.48 yuan — cuts of more than 50% before generics even arrive ^[4]. Novo Nordisk reported $36.1 billion in global semaglutide sales in 2025 ^[4].

India moved fastest. On March 21, 2026, Dr. Reddy's, Zydus, Alkem, Sun Pharma and Glenmark all launched generic semaglutide, claiming "Day 1 entry" ^[3]. Monthly prices included about 4,200 rupees for Dr. Reddy's Obeda, roughly 2,200 rupees for Zydus's product, and starting at 1,800 rupees for Alkem's ^[3]. IQVIA put Indian multi-dose vials as low as $14 a month and disposable pens at $19 a month for the lowest doses — discounts of up to 90% ^[1].

IQVIA has identified more than 70 integrated pharmaceutical companies seeking marketing approval for semaglutide, plus roughly 70 additional firms that can supply the active ingredient to others ^[1].

Why it matters for patients

For people in the United States, the short answer is that nothing changes at the pharmacy counter because of these expirations. Europe, the US and Japan have patent term extension mechanisms that push loss of exclusivity out further; in Europe, Supplementary Protection Certificates are expected to hold generic semaglutide back until 2031 ^[2]. IQVIA describes the US and most of Europe as the third and largest wave, after a second wave starting in the Baltics and parts of Central and Eastern Europe ^[1]. The sources do not give a specific US expiration date, so that timing is not yet known from this reporting.

The overseas prices are also not a preview of US prices. IQVIA cautions that a widely cited study by Professor Andrew Hill estimating $2.50 to $12 per month for finished semaglutide pens assumes a cost-plus model that is not how most companies price, and it leaves out sourcing and market-access costs ^[1]. Actual prices will vary by country, by channel, and by whether the market is public or out-of-pocket ^[1].

One detail does bear on the eventual US picture: the FDA treats peptide chains under 40 amino acids as generics rather than biosimilars, and semaglutide (31 amino acids) and tirzepatide (39 amino acids) both qualify ^[1]. That classification generally means a cheaper, faster development path than a biosimilar filing.

What happens next

China's Supreme People's Court upheld the semaglutide patent's validity on December 31, 2025, confirming the March 20, 2026 expiration date ^[5]. First Chinese approvals are speculated for the third quarter of 2026, with other filings possibly reaching market in 2027 ^[4]. Novo Nordisk still holds secondary patents on formulations, dosing regimens, indications and delivery devices, and has enforced them aggressively — obtaining 26 preliminary injunctions in Europe in October 2025 — so litigation and "skinny label" workarounds are likely in the newly open markets ^[2].