Semaglutide Patent Expired in China—But Generic Approvals Are Stuck in Regulatory Limbo

Here’s a wild situation playing out in the Chinese pharmaceutical market right now: the patent for Semaglutide has expired, yet not a single domestic generic version has received official approval.

More than a month has passed since the core compound patent for Semaglutide expired in China.

And basically… nothing.

No approvals. No certificates. No movement.

Several major Chinese pharmaceutical companies are now pointing fingers at an unlikely culprit: the China-Switzerland Free Trade Agreement and its provisions around data protection.

Why Is the Semaglutide Generic Approval Stuck?

• Patent Expiry: Relates to the legal right to exclude others from making/using the invention (Expired).
• Data Exclusivity: Relates to the protection of clinical trial data used for original drug approval (Still Active).
• FTA Overlap: Terms in international agreements (like China-Switzerland FTA) can mandate longer data protection.
• Regulatory Impact: Generic versions cannot be marketed until both protections lapse.

The short answer: data exclusivity.

Even though the core compound patent has technically expired, Chinese regulators are citing data protection clauses that appear to extend beyond the patent’s life.

This is a critical distinction most people miss.

A patent expiring doesn’t automatically mean you can flood the market with generics.

There’s another layer: data exclusivity periods, which protect the original clinical trial data that went into getting the drug approved.

And right now, that data is still locked up under the terms of an international trade agreement.

What Are China’s Major Pharma Companies Saying?

Reporters inquired with several domestic producers in the capacity of investors, and the responses revealed a coordinated regulatory pause across the industry.

Here’s what the major players are reporting:

Hangzhou Jiuyuan Gene Engineering (Hangzhou Jiuyuan Jiyin Gongcheng 杭州九源基因工程)

“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.”

Translation: They’re stuck waiting.

The regulatory machinery hasn’t rejected their application, but it hasn’t approved it either.

It’s frozen in place.

Livzon Pharmaceutical Group (Lizhu Jituan 丽珠集团)

Livzon’s securities department was slightly more forthcoming about the root cause.

“Their Semaglutide approval is currently suspended due to terms in the China-Switzerland FTA.”

Here’s the kicker: “From the company’s perspective, we have submitted all required materials, and the review process had already reached the final stage.”

In other words, Livzon did everything right.

All their documentation is in.

The review was nearly complete.

Then the process just… stopped.

The United Laboratories International Holdings (Lianbang Zhiyao 联邦制药)

“We are also waiting for the approval certificate. The reason for the lack of approval is the same for everyone.”

That last phrase is important: “the same for everyone.”

This isn’t a company-specific issue or a quality problem with individual applications.

This is a systemic regulatory freeze affecting the entire industry.

Understanding the China-Switzerland Free Trade Agreement Impact

So what exactly does the China-Switzerland FTA have to do with Semaglutide generics?

The agreement includes provisions on data exclusivity that go beyond the standard patent period.

Here’s the mechanism:

• The original patent expires after a set number of years
• But the clinical trial data used to prove the drug’s safety and efficacy remains protected under data exclusivity rules
• In some trade agreements, these data protection periods extend beyond the patent expiration date
• Regulators cannot approve a generic until both the patent AND the data exclusivity period have elapsed

The Chinese regulators appear to be interpreting the FTA as imposing a data protection obligation that outlives the core compound patent.

That’s why you have this bizarre scenario: patent expired, but no generics allowed.

What Does This Mean for the Chinese Pharma Market?

This situation reveals a tension between two competing forces in China’s pharmaceutical landscape:

1. Pressure to Develop Domestic Generics

China has been aggressively pursuing domestic drug development to reduce dependency on foreign pharmaceutical companies.

Generic Semaglutide would be a huge win—it’s a blockbuster drug with massive market potential.

Chinese firms have clearly invested in developing generic versions and are eager to get them to market.

2. International Trade Agreement Obligations

But China also signed the China-Switzerland FTA, which imposes data protection standards.

Honoring these international commitments sometimes conflicts with the speed at which China wants to approve domestic generics.

Right now, the trade agreement terms are winning.

The Bigger Picture: Data Exclusivity as a Market Barrier

This isn’t just about Semaglutide.

This situation highlights how data exclusivity periods can function as a de facto patent extension, even after the official patent has expired.

Pharmaceutical companies have long understood this dynamic:

• Patents expire on a predictable timeline
• But data exclusivity provisions can be negotiated as part of trade agreements
• These data protections create an additional barrier to generic entry
• The combined effect extends the period of market exclusivity well beyond the formal patent life

For investors and companies watching the Chinese pharmaceutical space, this is a crucial lesson:

Patent expiration doesn’t necessarily mean market access.

International trade agreements can impose additional regulatory constraints that extend the competitive moat.

What Happens Next?

The most likely scenario is that Chinese regulators will eventually approve domestic Semaglutide generics once they determine that the data exclusivity period has fully expired under the FTA terms.

But until then, the approvals will remain suspended.

This creates an interesting window for the original manufacturer (Novo Nordisk) to maintain pricing power in the Chinese market—longer than expected based on patent expiration alone.

For the Chinese pharmaceutical companies waiting in the wings with their generic formulations ready to launch, this is a frustrating holding pattern.

They’ve done the work, submitted the applications, and reached the final stages of review.

Now they’re just waiting for a regulatory permission slip that’s locked behind an international trade agreement.

The Bottom Line on Semaglutide Generic Approvals in China

The core takeaway: Patent expiration in China doesn’t automatically equal generic market entry, especially when international trade agreements impose data protection periods that extend beyond the patent life.

Right now, Hangzhou Jiuyuan Gene Engineering, Livzon Pharmaceutical Group, and The United Laboratories are all effectively frozen in place—waiting for regulators to officially close out the data exclusivity period mandated by the China-Switzerland FTA.

This situation underscores how international trade policy directly shapes the speed and dynamics of China’s pharmaceutical market, and why understanding data exclusivity provisions is just as important as understanding patent law when forecasting generic drug approvals.

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References

• Semaglutide Patent Expired for Over a Month with No ‘First Domestic Certificate’ – Cailian Press (Cailianshe 财联社)
• Investor Relations and Product Pipeline – Livzon Pharmaceutical Group (Lizhu Jituan 丽珠集团)
• Corporate Announcements and Research Progress – The United Laboratories (Lianbang Zhiyao 联邦制药)
• Product Development Updates – Hangzhou Jiuyuan Gene Engineering (Hangzhou Jiuyuan Jiyin Gongcheng 杭州九源基因工程)