Etravirine

In response to the common non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance problem in the clinical treatment of AIDS, etravirine, as a second-generation NNRTI antiviral drug, demonstrates unique clinical value. Its mechanism of action is to bind to the allosteric site of HIV-1 reverse transcriptase, and it can maintain inhibitory activity even against virus strains with common NNRTI resistance mutations. Clinically, it is mainly used in combination with other antiretroviral drugs to treat adult patients with type 1 HIV infection and pediatric patients over 6 years old who have received prior antiviral treatment, have NNRTI resistance or virological failure, providing an effective follow-up treatment option for drug-resistant populations.

At present, the global anti-AIDS drug market continues to expand. As a core alternative drug for NNRTI resistance, etravirine had a global market size of approximately USD 420 million in 2023, with a compound annual growth rate of 3.1% in the past three years. The growth momentum mainly comes from the improvement of treatment coverage for drug-resistant HIV patients in low- and middle-income countries. In terms of the competitive landscape, the original research product still accounts for more than 70% of the global market share, and generic pharmaceutical enterprises in India and China are gradually deploying this product. With the expiration of core patents, the market space for generic substitution is gradually releasing. At present, 3 domestic enterprises have submitted marketing applications for generic drugs.

The original research enterprise of etravirine is Janssen Pharmaceuticals under Johnson & Johnson, with the trade name "Intelence" (Chinese trade name "Yingtelai"). Its core compound patent in the United States expired in 2013, and the compound patent in China expired in 2012. The marketed original research preparations are mainly tablets with specifications of 100mg and 200mg, which have been included in the FDA Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Preparations for Chemical Drugs (Third Batch)*. In terms of domestic API registration, there are currently 4 valid API registration numbers, 2 of which are in status A and can be legally supplied for preparation production; 3 domestic enterprises have obtained marketing approval for etravirine tablets. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of etravirine impurity reference standards. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable reference material support for pharmaceutical enterprises in the links of API R&D, quality research and generic drug declaration.