China's semaglutide generics stay suspended under data exclusivity rules
A lapsed patent has not opened China's market to cheaper semaglutide, showing how data exclusivity can hold back generic copies after patent expiration.
China has not approved any domestic generic version of semaglutide, even though the drug's core compound patent expired there, because a data exclusivity period tied to the China-Switzerland free trade agreement is holding the applications in place [1]. The filings are suspended rather than rejected, and three of the country's larger manufacturers say they are waiting on the same regulatory question [1].
Hangzhou Jiuyuan Gene Engineering, Livzon Pharmaceutical Group and The United Laboratories International Holdings have all had their semaglutide generic approvals suspended, according to a report on the standoff [1]. Each gave a version of the same explanation.
Jiuyuan told reporters that the data behind the original drug is still protected: "The core reason we have not received the certificate is that the relevant data is still under protection. Currently, the approval process is simply in a suspended state; it is not a matter of rejection or approval, so it is difficult to reach a definitive conclusion." [1]
Livzon's securities department said its semaglutide approval was suspended "due to terms in the China-Switzerland FTA," and added that the company had submitted everything regulators asked for: "From the company's perspective, we have submitted all required materials, and the review process had already reached the final stage." [1]
The United Laboratories said the reason for the missing approval is "the same for everyone," describing a freeze that affects applicants generally rather than one company's filing [1].
The distinction at the center of the delay is between a patent and data exclusivity [1]. A patent gives its owner the right to exclude others from making or using an invention. Data exclusivity protects the clinical trial data used to win approval of the original drug. Under terms described in the China-Switzerland agreement, that protection can run past the patent's expiration. Regulators cannot clear a generic until both periods have run out [1].
Separately, Jiuyuan announced in a Hong Kong Stock Exchange filing on 25 February 2026 that China's National Medical Products Administration had accepted for review its marketing authorization application for Jikeqin, described as a generic version of Wegovy (semaglutide) intended for weight management in people with obesity or who are overweight [2]. A phase III trial of Jikeqin, approved in China in January 2024, has been completed, and the results were submitted to the drug evaluation center for review [2].
The reports do not say how long the relevant data exclusivity period lasts or when it ends; that has not been disclosed [1][2]. They also do not address whether these products would be sold outside China.
Other markets are moving at different speeds. In January 2026, Sun Pharmaceutical, Zydus Lifesciences and Alkem Laboratories received approval in India to make and sell generic semaglutide [2]. Health Canada is reviewing nine generic semaglutide submissions, including applications from Sandoz, Apotex, Teva, Aspen Pharmacare and Taro Pharmaceuticals; the semaglutide patent has expired in Canada and regulatory exclusivity there expired in January 2026 [2].
Why it matters for patients
For patients in the United States, the practical effect of the Chinese standoff is indirect. The applications described here cover the Chinese market, and the reports do not address whether any of these products would reach the US [1][2]. Nothing in them changes what is available at a US pharmacy.
The larger point is about timing. A patent expiring does not by itself open a market to cheaper copies; data exclusivity written into trade agreements can extend the period when only the original product can be sold [1]. That is the mechanism now holding up semaglutide generics in China, and the report describes it as a feature of drug approvals rather than something unique to this molecule [1]. For anyone tracking when less expensive semaglutide might reach a given market, the Chinese queue is one piece of the picture.
What happens next
No date has been disclosed for when the Chinese data exclusivity period ends, and no timeline for decisions by China's National Medical Products Administration has been reported [1][2]. The scenario described is that regulators eventually approve domestic generics once they determine the protection period has expired, with Novo Nordisk able to keep its pricing power in China in the meantime [1]. Jiuyuan's application was accepted for review on 25 February 2026, and no decision date has been reported [2].
Sources
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