Elvitegravir

As a core component of HIV integrase inhibitor antiretroviral drugs, elvitegravir inhibits viral replication and amplification by blocking the key step of HIV viral DNA integration into the host cell genome. In clinical practice, it is often combined with pharmacokinetic enhancers and other anti-AIDS drugs to form fixed-dose compound preparations for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents over 12 years old. It can significantly reduce the viral load of patients and delay disease progression, and is one of the important component drugs of current cocktail therapy.

At present, the global anti-AIDS drug market size has exceeded 40 billion US dollars, of which integrase inhibitors account for more than 45%, with a compound annual growth rate maintained at around 8%. As a representative variety of the new generation of integrase inhibitors, elvitegravir has the advantages of high clinical compliance and good drug resistance of its compound preparations, so its market demand continues to rise. In terms of the domestic market, with the intensification of AIDS prevention and control efforts and the expansion of the scope of free medication, the application enthusiasm for elvitegravir-related generic drugs is relatively high. At present, the compound preparations of 3 enterprises have been approved for marketing, and there is broad space for domestic substitution of API.

The original research enterprise of elvitegravir is Gilead Sciences, and the original research trade name is Vitekta. The expiration time of its core compound patent in the United States is 2023, and the expiration time of the core compound patent in China is 2022. The main dosage form approved by the original research is oral tablet, with the specification including 150mg. At present, this original research tablet has been included in the FDA Reference Listed Drug Catalog, but has not been included in the Chinese Chemical Reference Preparation Catalog for the time being. In terms of domestic API registration, at present, the elvitegravir APIs of 5 enterprises have completed registration in CDE (status is A), and the registration applications of another 8 enterprises are in the review and approval stage. A number of domestic enterprises have obtained approval for marketing of their elvitegravir compound preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full range of elvitegravir impurity reference standards, covering the whole research chain including synthesis process impurities and degradation impurities. Most of the products are in stock, and orders placed before 16:00 on the same day can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the various needs of enterprises in the stages of API R&D, quality research and declaration.