Semaglutide patents have just expired, and a group of generic drug companies are already lining up for approval.

Ask AI · Why do domestic generic drugs prioritize targeting diabetes indications over weight loss?

On March 20, the core patent of semaglutide (NVO.US) held by Novo Nordisk officially expired in China. A number of domestic generic drug manufacturers have begun preparations and are actively working towards market approval. Data shows that at least 10 pharmaceutical companies in China have submitted applications for the launch of semaglutide generics.

Semaglutide is a star weight-loss drug that was originally developed for treating type 2 diabetes. Later, Novo Nordisk recognized its potential for weight management and officially approved it for weight loss indications in 2021, greatly expanding its target audience. By 2025, the global sales of semaglutide products are expected to reach approximately 228.288 billion Danish kroner (about 34.6 billion USD), with sales in China accounting for roughly 6.815 billion Danish kroner.

This huge commercial success has attracted many innovative pharmaceutical companies to develop similar drugs. Before the patent expired, at least 14 similar drugs had already been launched in China, with another 6 drugs having submitted applications for market approval.

Due to the large number of similar drugs leading to early price wars, the weight-loss drug market has become a red ocean. Experts analyzing financial news suggest that after generics enter the market, price competition will no longer be a competitive advantage for innovative drug companies. Instead, competing on efficacy, indication scope, and ease of administration will become the main strategies for original research-based pharmaceutical companies.

Generic drug manufacturers have been preparing for a long time, and the semaglutide patent was nearly due to expire early.

According to the Mo熵 Pharmaceutical Database, at least 10 domestic pharmaceutical companies have submitted applications for the launch of semaglutide generics, and many other drugs are in clinical development. Among them, East China Pharmaceutical (000963.SZ), Huisheng Biological (a subsidiary of Sihuan Pharmaceutical (00460.HK)), Federation Pharmaceutical (03933.HK), and Jiuyuan Gene (02566.HK) submitted their applications as early as October last year.

In fact, domestic companies had begun their semaglutide development even earlier. In June 2021, East China Pharmaceutical filed an application to invalidate the core patent of semaglutide, and on September 5, 2022, the National Intellectual Property Administration ruled that all core patents of semaglutide were invalid, which nearly accelerated the patent expiration date. However, Novo Nordisk appealed this decision, and in December 2025, the Supreme People’s Court issued a final ruling overturning the previous decision, confirming that Novo Nordisk’s patent remains valid.

During the ongoing litigation, Jiuyuan Gene, Livzon Pharmaceutical, Qilu Pharmaceutical, East China Pharmaceutical (000963.SZ), and Sihuan Pharmaceutical also submitted applications for semaglutide generics, but these biosimilars were not approved due to the patent protection period not being over.

Financial news notes that the indications most commonly submitted by domestic manufacturers for semaglutide generics are primarily for type 2 diabetes. This means that for domestic semaglutide to be legally used for weight loss, it still needs to wait for the relevant indications to be approved, which will take some time.

Deng Zhidong, Executive Vice President of the Hubei Province Modern Service Industry Association, explained to financial news that the initial focus on diabetes indications for generics is to facilitate quick access to medical insurance and hospital channels. Although the “weight loss” indication has not yet been officially approved, doctors can use off-label prescribing (“super-indication”) in clinical practice (i.e., prescribing based on weight loss needs). Once the weight loss indication is officially approved in the future, it can be promoted legitimately. This two-step approach can remove barriers to marketing in the weight loss sector.

Jin Chunlin, Director of the Shanghai Health and Wellness Research and Development Center, stated that the absence of a weight loss indication will significantly impact the initial promotion of generics. The first batch of patients will mainly be hospital-based diabetics, and doctors’ prescriptions will often target diabetes. However, as additional indications are approved later, this impact will gradually diminish.

Both interviewees agree that although capacity issues with peptide drugs like semaglutide existed in the past, domestic pharmaceutical companies have already preemptively expanded sufficient production capacity, and the supply chain is mature. Therefore, the core future challenge will shift from “shortage” to “channel and cost competition.” Overall, it is expected that the launch of generics will trigger a larger-scale price war, with competition primarily based on cost, scale effects, and channel advantages.

Expansion of indications and administration methods, with leading pharmaceutical companies leveraging technology to defend their market positions.

Semaglutide belongs to the GLP-1 receptor agonist class, developed around the GLP-1 target. Currently, the GLP-1 market is highly competitive. According to the Mo熵 Pharmaceutical Database, at least 14 similar drugs are already on the market in China, with another 6 in development. These drugs mainly target diabetes and weight loss.

Many of these drugs are gaining competitive advantages over semaglutide by optimizing their mechanisms of action. For example, Eli Lilly (LLY.US) launched tirzepatide, which not only targets GLP-1 but also incorporates GIP receptor activity, reducing side effects and improving efficacy. In June 2025, Innovent Biologics (01801.HK)'s mazudutide was approved, which introduces the GCG receptor target, increasing energy expenditure by boosting basal metabolic rate and promoting fat burning, thereby enhancing weight loss effects.

As a competitor, Novo Nordisk is also developing semaglutide’s potential, focusing on expanding indications and optimizing administration methods. Currently, semaglutide has been approved for 8 indications, including not only diabetes and weight loss but also kidney failure, chronic kidney disease, end-stage renal disease, heart failure, and peripheral vascular disease.

In terms of administration, Novo Nordisk is launching oral GLP-1 formulations, such as Rybelsus (diabetes version) and Wegovy (weight loss version). In January 2025, the oral semaglutide was approved in China, though sales data in many regions has yet to be reported, and marketing efforts are ongoing. The oral bioavailability of semaglutide is approximately 0.4% to 1%, which is relatively low, but continuous oral dosing over 7 days can achieve blood concentrations comparable to a 1mg subcutaneous injection.

Deng Zhidong predicts that future generic drugs will mainly compete on cost-effectiveness, maintaining a foothold in basic treatment markets, while original brands and innovative drugs will differentiate themselves through stronger efficacy and greater convenience, occupying high-end market segments.