Semaglutide exclusivity begins expiring outside the United States

Novo Nordisk's grip on semaglutide — the molecule in Ozempic, Wegovy and Rybelsus — began loosening outside the United States at the start of 2026. Canada's regulatory data protection for the drug expired in January, and patents in India, China and Brazil are set to expire in March 2026 ^[1][2]. US patents on semaglutide run until 2032, so American prices are not directly affected ^[2].

What expired, and where

In Canada, semaglutide was covered by two separate protections. Eight-year data exclusivity, which began with approval in 2018, ran out in early 2026; the main protection was set to expire January 4, 2026 ^[1]. A separate Canadian patent lapsed back in 2020 after a maintenance fee of roughly 1,200 Canadian dollars went unpaid ^[1]. Novo had obtained a certificate of supplementary protection that would have run from March 2026 to March 2028, but because it was tied to the lapsed patent, it cannot take effect — an analysis the Public Health Agency of Canada confirmed to Labiotech ^[1]. Sandoz and Apotex are expected to launch generic semaglutide in Canada, with Sandoz's CEO publicly describing Canada as a launchpad ^[1].

The bigger populations are in Asia and South America. C&EN lists patent expiry in March 2026 for India (947 million adults), China (1.07 billion adults) and Brazil (155 million adults), with Türkiye and Canada also expiring during 2026 ^[2]. Roughly one-third of the world's adults with obesity live in those markets, and India and China alone account for about a quarter, according to Iqvia's Aurelio Arias ^[2].

Generic makers have been preparing for years. At least 10 Indian firms have asked regulators for permission to run human trials of semaglutide, and 17 candidates in China have reached Phase 3 or the premarket application stage ^[2]. India's Dr. Reddy's Laboratories has already received permission from regulators to market generic semaglutide, and Alkem, Biocon, Lupin and Sun Pharma are also moving in ^[2]. Lupin told investors it is developing both injectable and tablet forms for India and South Africa in 2026, and its CFO said India's semaglutide market could be worth $1 billion a year ^[2]. Whether specific generic products actually reached Indian pharmacy shelves in the first quarter is not documented in these sources.

Price forecasts are large but imprecise. One consultant told C&EN generics "could lower the cost by 80% in some cases" ^[2]; an IP attorney quoted by Labiotech said analysts expect drops of 50% to 80% versus brand prices ^[1].

Why it matters for patients

For people in the US, the practical effect in 2026 is indirect. American patents block generic semaglutide here until 2032 ^[2]. At least 13 companies have told the FDA they are interested in selling generic semaglutide in the US, and the first to file gets a 180-day exclusivity window ^[2]. Unlike India and China, the FDA generally does not require new human trials for generics that are chemically equivalent to the original ^[2].

What US patients see instead is brand-level price competition. Novo's Wegovy pill was approved December 22, 2025 and launched January 5, 2026, with self-pay list prices of $149 a month for the 1.5 mg starting dose, $199 for 4 mg, and $299 for 9 mg and 25 mg ^[4][5]. Wegovy pens are listed at $349 a month and Wegovy HD at $399 ^[5]. Novo reported US adjusted sales down 11% at constant exchange rates in the first quarter of 2026 on lower realized prices, while International Operations sales rose 6% on higher volumes ^[3].

Overseas price drops also do not make it legal or safe to import copies, and product quality varies by country. Generic versions abroad are likely to be made by fully synthetic routes rather than Novo's yeast-fermentation-plus-synthesis process ^[2].

What happens next

March 2026 is the key date for India, China and Brazil patent expiry ^[2]. Novo says the first Wegovy pill launches outside the US are expected in the second half of 2026, pending regulatory decisions ^[3]. US generic entry is not expected before 2032 ^[2].