Competition

Semaglutide patent lapses in China and India, opening a first wave of generic competition

The semaglutide patent has expired in China, and generics launched in India, but the US is not part of this first wave and no US price or supply change has been reported.

By the Semaglutides news desk·
Semaglutide patent lapses in China and India, opening a first wave of generic competition
Image: vcbeathealth.com

Novo Nordisk's core semaglutide patent expired in China on March 20, 2026, and generic versions of the drug went on sale in India the next day, part of a first wave of off-patent competition across eight markets [1][3][4].

The Chinese patent covering the semaglutide molecule ran until March 20 after the Supreme People's Court upheld it in a December 31, 2025 ruling [5]. IQVIA lists the first wave of markets losing exclusivity in 2026 as Canada, Brazil, China, India, Mexico, Turkey, Saudi Arabia and South Africa [1]. Patent firm Reddie & Grose says core patents covering the active ingredient in Ozempic and Wegovy expire in China, India and Brazil in 2026, and that a core patent in Canada was allowed to lapse [2]. Saudi Arabia's local patent was never filed, so the country did not have a typical period of market protection, IQVIA said [1].

IQVIA said the eight countries together account for 38% of the world's adults living with obesity, and projected that obesity prevalence there will keep rising, with the largest increases expected in Mexico (+18%), Brazil (+17%) and Saudi Arabia (+16%) through 2050 [1]. Reddie & Grose said about a quarter of the world's obese population is thought to live in India and China alone [2].

Regulation of the new products differs by country. Canada and Saudi Arabia treat semaglutide as a chemical drug requiring only bioequivalence studies, while Brazil, India and South Africa classify it as a biologic. China treats it as a biologic if made by recombinant methods and a chemical drug if synthesized, but still requires full clinical studies. Turkey is expected to follow European practice, treating the synthetic version as a generic and the recombinant version as a biosimilar, IQVIA said [1]. IQVIA counted more than 70 integrated pharmaceutical companies applying for marketing authorization and about 70 more companies able to make the semaglutide ingredient for others [1].

In India, launches on March 21, 2026, were advertised as "Day 1 entry" on expiry of the Indian patent [3]. Dr. Reddy's launched Obeda, a pre-filled disposable pen for type 2 diabetes, at about INR 4,200 per month. Zydus Lifesciences launched Semaglyn, Mashema and Alterme, approved for both type 2 diabetes and obesity, at an average monthly cost of about INR 2,200. Alkem Laboratories' Semasize, Obesema and Hepaglide start at INR 1,800 for a month's dosage. Glenmark's GLIPIQ vials were priced at about INR 325 to INR 440 per week, and Sun Pharma's Noveltreat and Sematrinity at reported weekly costs of about INR 900 to INR 2,000 and INR 750 to INR 1,300 [3]. IQVIA reported that Indian prices had already fallen by as much as 90%, with multi-dose vials as low as $14 per month and disposable pens at $19 per month for the lowest dose forms [1].

In China, 12 generic semaglutide products from 10 companies had submitted registration applications as of March 20, according to a review of the National Medical Products Administration website [4]. Qilu Pharmaceutical and Changchun Bcht Biotechnology filed as modified new chemical drugs with lower trial requirements and are widely expected to win the first approvals, possibly as early as the third quarter of 2026 [4]. Chinese list prices for the original semaglutide have already fallen by more than 50%: the 1.34 mg/mL pre-filled pen dropped from 1,120 yuan to 478.8 yuan, and the 2.27 mg/mL 3 mL weight-loss pen from 1,893.67 yuan to 987.48 yuan [4]. Novo Nordisk reported $36.1 billion in global semaglutide sales in 2025, up more than 10%, with about 6.7 billion yuan of that in Greater China [4].

Why it matters for patients

The United States is not in this first wave. The US, Europe and Japan have patent term extensions, and Reddie & Grose expects Novo Nordisk's loss of exclusivity in Europe in 2031; IQVIA places the US and most of Europe in a third and largest wave of markets [1][2]. No change to US availability, insurance coverage or pricing has been reported. What is already changing is that the same molecule is sold under different brand names, at very different prices, and under different regulatory standards in different countries [1][3]. Generic semaglutide sold in India or China is not FDA-approved, and IQVIA notes that Turkey restricts online purchasing of semaglutide, while Saudi Arabia relies more on state-provided care than out-of-pocket payment [1]. Novo Nordisk is also enforcing secondary patents on formulations, dosing and devices, and obtained 26 preliminary injunctions in Europe in October 2025; such patents could still delay competitors even where core protection has ended [2].

What happens next

In China, the first domestic generic approvals are expected as early as the third quarter of 2026, with Jiuyuan Gene and Huadong Medicine, which filed under a biosimilar-style pathway, speculated to reach the market in the first and second halves of 2027 respectively [4]. IQVIA expects a second wave of European markets, starting with the Baltics and parts of Central and Eastern Europe, before the larger US and Western European wave [1]. Individual approval dates, and how far prices fall in each market, have not been disclosed [1][4].

Images from the sources

Semaglutide patent lapses in China and India, opening a first wave of generic competition
vcbeathealth.com
Semaglutide patent lapses in China and India, opening a first wave of generic competition
vcbeathealth.com
Semaglutide patent lapses in China and India, opening a first wave of generic competition
vcbeathealth.com
Semaglutide patent lapses in China and India, opening a first wave of generic competition
vcbeathealth.com

Sources

  1. https://www.iqvia.com/locations/emea/blogs/2026/04/your-questions-answered-off-patent-semaglutide-in-2026
  2. https://www.reddie.co.uk/2026/02/09/changes-in-the-ozempic-patent-landscape/
  3. https://www.pearceip.law/2026/03/21/generic-semaglutide-launches-in-india-including-by-dr-reddys-zydus-alkem-sun-pharma-glenmark/
  4. https://www.vcbeathealth.com/article/2957
  5. https://eagle-ip.com/beijing-supreme-peoples-court-upholds-novo-nordisk-semaglutide-patent-in-china-based-on-post-filing-data

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