Cobicistat

In response to the clinical pain point that protease drugs for HIV treatment are metabolized quickly and require frequent administration, the application value of cobicistat as a new pharmacokinetic booster has become increasingly prominent. Cobicistat itself has no anti-HIV activity. It highly selectively inhibits cytochrome P450 3A (CYP3A) enzymes to reduce the metabolic degradation of co-administered antiretroviral drugs, significantly increase the plasma concentration of the latter and prolong their duration of action, thereby reducing the frequency of administration and the risk of adverse reactions. At present, this drug is mainly formulated into compound preparations with emtricitabine, tenofovir alafenamide, elvitegravir and other drugs for the initial treatment of HIV-1 infection in adults and adolescents over 12 years old, and is a core component to simplify HIV treatment regimens and improve patients' medication compliance.

The global market size of anti-HIV drugs continues to expand, and the market demand for cobicistat, a core component of compound preparations, is rising steadily. In 2023, the global sales of fixed-dose compound preparations containing cobicistat exceeded 5 billion US dollars, among which single-tablet compound preparations accounted for nearly 90% of the market share due to their convenient administration. The domestic market is currently in the stage where original research products dominate and generic drugs are accelerating their layout. As of 2024, 3 domestic enterprises have submitted marketing applications for cobicistat active pharmaceutical ingredients (APIs), and the generic compound preparations of 2 enterprises have passed the consistency evaluation. With the continuous release of long-term medication demand of people living with HIV, the market growth rate of cobicistat APIs is expected to remain above 12%.

The original research enterprise of cobicistat is Gilead Sciences, Inc., and the original trade name is Tybost. The core compound patent in the United States expired in 2025, and the compound patent in China will expire in 2026. The approved dosage form of the original research product is tablet with a specification of 150mg, which has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Listed Drugs for Chemical Drugs (Fourth Batch)* in China. At present, there are 8 domestic registration numbers for cobicistat APIs, among which 5 are in Status A, which can directly support the application of preparations. Four kinds of compound preparations containing cobicistat have been approved for marketing in China, covering original research products and domestic generic drugs. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for cobicistat APIs, which fully cover various impurity research needs such as those related to synthesis processes and degradation products. Most products are available from stock, and stock orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of pharmaceutical enterprises for qualitative and quantitative research on impurities and the establishment of quality standards.