Emtricitabine

In the global antiretroviral treatment system, nucleoside reverse transcriptase inhibitors have always been the core component of the combination therapy for HIV infection, and emtricitabine is a variety in this category with extremely high clinical recognition. Its mechanism of action is to embed into the viral DNA strand and terminate the extension of the DNA strand, thereby inhibiting the replication of HIV-1, HIV-2 and hepatitis B virus. It is often used in combination with other antiretroviral drugs in clinical practice to treat HIV-1 infection in adults and children over 12 years old. It can also be combined with other drugs for the treatment of chronic hepatitis B. It is one of the core drugs in the pre-exposure prophylaxis (PrEP) regimen, which can greatly reduce the risk of HIV infection in high-risk groups.

The global market size related to emtricitabine has exceeded 6 billion US dollars in 2023, with a compound annual growth rate maintained at around 4%. The core driving force for growth comes from the increase in demand for HIV prevention and control in low- and middle-income regions and the promotion of PrEP indications. The market pattern is characterized by the dominance of the original research drug and the rapid penetration of generic drugs. The proportion of generic drugs in the European and American markets has exceeded 35%. With the expiration of patents and the advancement of centralized procurement in the Chinese market, the market share of domestic generic drugs has increased from less than 8% in 2020 to 42% in 2024. At present, more than 15 enterprises have obtained approval for generic drug preparations, and the price has dropped by more than 80% compared with the original research drug.

The original research enterprise of emtricitabine is Gilead Sciences, and the original research trade name is "Emtriva". Its core compound patent in the United States expired in 2021, and the core compound patent in China expired in 2021. The dosage forms approved for the original research drug include capsules (200mg) and oral solution (10mg/ml), which have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. Up to now, there are more than 20 emtricitabine API registration numbers on the API registration platform of China's Center for Drug Evaluation (CDE), among which nearly 15 are in "A" status (can be used in marketed preparations). A number of domestic enterprises have obtained approval for the marketing of emtricitabine single-agent and compound preparations. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the R&D and quality control needs of emtricitabine, CATO can provide a full set of impurity reference materials for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide a stable and reliable material basis for pharmaceutical enterprises' impurity research, quality standard establishment and declaration work.