Semaglutide exclusivity starts to end outside the US as generic makers prepare

Semaglutide's exclusive hold on several large markets outside the United States is starting to end. Canada's data protection for the drug lapsed in January 2026, and semaglutide patents expire in March 2026 in India, China, and Brazil ^[1][2]. Generic drugmakers have been preparing for those dates for years ^[2].

Canada: a lapsed patent and an invalid certificate

Semaglutide is the active ingredient in Ozempic, Wegovy, and Rybelsus. Novo Nordisk's Canadian patent on it lapsed in 2020 after a missed maintenance fee reported at around 1,200 Canadian dollars ^[1]. Novo also filed for a certificate of supplementary protection, which was granted and listed as taking effect in March 2026. But the Public Health Agency of Canada confirmed the certificate will not take effect because the patent it depends on has expired. "In Canada, a CSP can only take effect if the underlying patent is still in force," the agency said ^[1].

Data protection, which is separate from patents, blocks copies for eight years after a drug's approval. In Canada that period ends in January 2026 ^[1]. Sandoz and Apotex are expected to launch generic semaglutide in Canada as soon as that protection ends, and Sandoz CEO Richard Saynor has said the company would use Canada as a launchpad ^[1]. Steven Shape, an intellectual property lawyer at Omnus Law, said analysts expect prices for the brand products to fall by 50% to 80% once generics arrive, and that Canada is Novo Nordisk's second-largest semaglutide market ^[1].

India, China and Brazil

Patents expire in March 2026 in India, China, and Brazil ^[2]. In China, 17 candidates have reached phase 3 trials or the premarket application stage ^[2]. In India, at least 10 generics firms have asked the drug regulator for permission to run human trials, and Dr. Reddy's Laboratories has already received permission to market generic semaglutide ^[2]. Lupin plans injectable and tablet forms for India and South Africa in 2026; its chief financial officer said India's semaglutide market could be worth $1 billion a year ^[2]. Türkiye's patent also expires in 2026 ^[2].

Nilaya Varma of the consulting firm Primus Partners said generics "could lower the cost by 80% in some cases" ^[2]. Aurelio Arias of the health information company Iqvia said India and China together represent about a quarter of the world's adults with obesity, and that close to one-third of the world's adults with obesity live in countries where semaglutide goes off patent in 2026 ^[2].

The US market is not affected yet

Novo Nordisk holds semaglutide patents in the US until 2032 ^[2]. At least 13 companies have contacted the FDA about selling generic semaglutide in the US, and the first to file would get 180 days as the sole seller of the generic version ^[2]. The FDA does not require most generic makers to run human trials if they can show the copy is chemically equivalent ^[2]. The expirations apply to semaglutide only. Tirzepatide, sold as Mounjaro and Zepbound, is a different molecule ^[2].

Novo's first-quarter 2026 results show the brand business still growing by volume while prices fall. Adjusted sales fell 4% at constant exchange rates and adjusted operating profit fell 6%, while adjusted obesity care sales rose 22% ^[3]. The Wegovy pill launched in the US on January 5, 2026, and weekly prescriptions passed 200,000 in the week ending April 17 ^[3].

Why it matters for patients

For patients in Canada, India, China, Brazil, and Türkiye, cheaper copies of semaglutide are the likely near-term result. When each product reaches pharmacies and what it costs will vary by country, and those details have not been reported. Canadian launches were expected to begin as soon as January 2026 ^[1], and Indian companies have said they plan 2026 launches ^[2]. Novo Nordisk's own products will still be sold alongside them.

For US patients, nothing changes yet. Generic semaglutide cannot be sold in the US while patents run to 2032 ^[2]. Novo's published self-pay prices for Wegovy are $149 to $299 a month for the pill, depending on dose, and $349 a month for the 1.7 mg and 2.4 mg pens, with a 7.2 mg pen at $399 ^[5].

How regulators outside the US will verify the quality of copycat peptides, and whether supply will keep up with demand, has not been reported.

What happens next

Patent expirations in India, China, and Brazil take effect in March 2026 ^[2]. Novo Nordisk expects the first launches of the Wegovy pill outside the US in the second half of 2026, pending regulatory decisions ^[3]. US generic entry remains tied to patents that run to 2032 ^[2].