Why Are Risks of Imported Drug Supply Disruptions Drawing Attention? An Analysis of Domestic Alternatives Amid the Patent Expiration Wave

In recent years, the restructuring of global pharmaceutical supply chains, strategic adjustments by multinational pharmaceutical companies, and the gradual expiration of drug patents have brought increasing attention to the stability of imported drug supplies. From rare disease therapies and innovative oncology drugs to treatments for chronic diseases, topics such as “imported drug shortages,” “withdrawal of originator drugs from the market,” and “whether domestic alternatives are reliable” have become major concerns among patients and the healthcare community.

Based on integrated industry research conducted by Dengyue Research, the coming years are expected to witness a significant "Patent Cliff" cycle, during which numerous blockbuster originator drugs will lose patent protection. As a result, the markets for generic drugs and biosimilars are expected to expand rapidly. During this transition, patients may gain access to more affordable treatment options, but they should also remain vigilant against emerging medical scams involving claims of “drug shortages,” “special purchasing channels,” or “overseas miracle drugs.”

Why Are Risks of Imported Drug Supply Disruptions Drawing Attention?

Drug supply disruption does not necessarily mean a medication has been permanently discontinued. Instead, it may refer to situations where a drug experiences supply interruptions, commercial withdrawal, registration expiration, or temporary shortages in specific countries or regions.

Factors contributing to instability in imported drug supplies include:

● Global supply chain restructuring;

● Shortages of active pharmaceutical ingredients (APIs) or manufacturing site changes;

● Corporate strategic adjustments;

● High operating costs associated with small market sizes;

● Intensified competition following patent expiration;

● Changes in reimbursement policies and drug pricing negotiations across different countries.

This issue is particularly relevant in the rare disease sector, where limited patient populations may result in insufficient market coverage for certain imported orphan drugs, potentially affecting long-term supply stability.

Which Imported Brand-Name Drugs Are Expected to Enter Patent Expiration Cycles in the Coming Years?

According to publicly available patent information and industry forecasts, numerous blockbuster drugs are expected to face patent expiration or loss of market exclusivity between 2026 and 2030.

Key therapeutic areas include:

Oncology

● PD-1/PD-L1 immunotherapies;

● Certain HER2-targeted therapies;

● CDK4/6 inhibitors;

● PARP inhibitors;

● Certain ADC-related technology platforms.

Autoimmune Diseases

● TNF-α inhibitors;

● IL-17 inhibitors;

● IL-23 inhibitors;

● JAK inhibitors.

Rare Diseases

● Certain enzyme replacement therapies;

● Certain complement inhibitors;

● Selected treatments for inherited metabolic disorders.

It is important to note that patent expiration timelines vary by country and may be affected by patent term extensions, data exclusivity periods, and market exclusivity protections. Therefore, patent expiration does not necessarily mean that generic versions will become available immediately.

Patent Expiration of Major Imported Drugs and the Trend Toward Domestic Alternatives

As the global pharmaceutical industry enters a concentrated period of patent expirations, many imported originator drugs that have long dominated their markets are facing increasing competition from generics and biosimilars. Understanding these trends can help patients better prepare for potential changes in treatment availability.

Case 1: Humira (Adalimumab) — The End of the World's Best-Selling Drug Era

Developed by AbbVie, Humira (adalimumab) remained the world's top-selling pharmaceutical product for many years. It is widely used in the treatment of rheumatoid arthritis, psoriasis, Crohn's disease, and other autoimmune conditions.

With key patents expiring, multiple adalimumab biosimilars have entered markets across the United States, Europe, and Asia.

This development is widely regarded as a landmark event in the biosimilar era.

For patients:

● Originator products will continue to remain available;

● More biosimilar options are becoming accessible;

● Drug affordability and treatment accessibility are expected to improve.

Case 2: Keytruda (Pembrolizumab) — A Turning Point in Cancer Immunotherapy

Developed by Merck & Co., Keytruda (pembrolizumab) is one of the world's most influential PD-1 immunotherapy drugs.

The drug has been approved for multiple cancer indications, including:

● Non-small cell lung cancer;

● Melanoma;

● Head and neck cancers;

● Gastric cancer;

● Esophageal cancer.

As patent protection gradually approaches expiration, numerous companies worldwide have begun developing biosimilar versions.

However, industry experts generally agree that:

Due to the complexity of monoclonal antibody development, even after patent expiration, commercial alternatives must still undergo rigorous clinical evaluation and regulatory review before reaching the market.

How Can the Launch Timing of Generic Drugs Be Predicted?

One of the most common questions from patients is:

“How long after a patent expires will a generic version become available?”

In reality, there is no universal answer.

The process generally involves the following stages:

1.  Patent expiration or successful patent challenge;

2.  Completion of pharmaceutical development;

3.  Conducting bioequivalence studies;

4.  Submission of a marketing application;

5.  Regulatory approval;

6.  Commercial launch and supply.

For conventional small-molecule drugs, some generics may become available within one to three years after patent expiration.

For biologics, biosimilars, and complex formulations, development barriers are significantly higher, often resulting in longer timelines.

Therefore, patients should be cautious about unverified online claims suggesting that a drug is “about to be launched” or has “already received internal approval.”

Conclusion

For patients, the most important criteria when choosing a medication should always be safety, efficacy, and regulatory compliance, rather than simply whether a product is imported or domestically produced. At the same time, the growing diversity of treatment options means that patients are navigating an increasingly complex information landscape.

Professional patient service platforms such as Dengyue Pharmaceutical are playing an increasingly important role in bridging information gaps. By integrating global drug information, compliant medication guidance, international healthcare resources, and patient support services, these platforms help patients better understand originator drugs, domestic innovative therapies, biosimilars, and other treatment options, improving access to therapies while reducing risks associated with information asymmetry.