Oseltamivir

As a respiratory infectious disease under priority prevention and control in the global public health field, influenza causes millions of severe cases annually during seasonal epidemics, and neuraminidase inhibitors are currently recognized as the mainstream therapeutic drugs against influenza. Oseltamivir is a highly selective neuraminidase inhibitor, which blocks the release of viruses from infected host cells by inhibiting the activity of neuraminidase on the surface of influenza viruses, thereby reducing the replication and spread of viruses in the body. Its indications cover the treatment and prevention of influenza A and influenza B, and the applicable population includes children aged 1 year and above as well as adults. Special populations such as elderly patients and immunocompromised groups can use it in a standardized manner after assessment. It is one of the core drugs for influenza prevention and control recommended by the WHO.

In China's anti-influenza drug market, oseltamivir has long accounted for more than 90% of the market share. In 2023, its terminal sales in public medical institutions exceeded 6 billion yuan, and retail sales exceeded 3 billion yuan, with an annual growth rate remaining above 25%. The market competition presents a dual-track pattern of "original research + domestic generic drugs". More than 10 domestic enterprises have obtained approvals for generic drug preparations. In the provincial centralized procurement in 2022, the average price of oseltamivir for suspension was reduced by more than 80%, which greatly improved clinical accessibility. On the API supply side, domestic enterprises have realized independent mass production, and the production capacity of some manufacturers can meet nearly 40% of the global market demand.

The original research enterprise of oseltamivir is Roche, and the trade name of the original drug is "Tamiflu". Its core compound patent expired in China in 2016, and other process-related patents expired successively from 2017 to 2020. The main dosage forms approved for the original drug include capsules (75mg) and for suspension (60mg/bottle, 30mg/bottle), which have been included in the China Listed Drug Catalog as reference preparations, and are also listed in the FDA Reference Preparation Catalog. As of November 2024, there have been more than 30 oseltamivir API registration records on China's CDE API Registration Platform, among which nearly 20 are in the status of "A" (approved for use in marketed preparations). The domestically approved oseltamivir preparation varieties have covered three dosage forms: capsules, for suspension, and granules. (Data as of November 2024, please refer to the official CDE website for the latest information)

In response to the demand for oseltamivir quality research and compliance declaration, CATO provides a full set of impurity reference standards for this API, fully covering synthetic process impurities, degradation impurities and official reference substances. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully support the whole process of pharmaceutical enterprises' process validation, stability research and registration declaration.