Dolutegravir

As one of the core drugs in the field of global AIDS prevention and control, dolutegravir is an HIV integrase inhibitor class of antiretroviral drug. It competitively binds to the active site of HIV integrase, blocks the integration process of viral cDNA with the genome of host cells, and thus inhibits viral replication. Its clinical indications cover both treatment-naive and treatment-experienced adult and adolescent patients aged above 12 with HIV-1 infection. With the advantages of high resistance barrier, low incidence of adverse reactions and few drug-drug interactions, it has been recommended as the first-line preferred treatment regimen by multiple international AIDS diagnosis and treatment guidelines, significantly improving the long-term quality of life of people living with HIV.

The global market size related to dolutegravir had exceeded USD 6 billion in 2023, with a compound annual growth rate of around 7% in the recent 3 years. The main growth drivers are the improvement of AIDS prevention and control coverage in low- and middle-income countries and the popularization of single-tablet fixed-dose combination regimens. In the Chinese market, with the implementation of the national centralized drug procurement policy, the price of a single dolutegravir tablet has dropped to the level of RMB 100. The domestic terminal market size exceeded RMB 1.5 billion in 2023, and generic drugs accounted for more than 65% of the market share. Both original research and generic products cover the two major channels of public health procurement and retail, and the market supply pattern is stable.

The original research enterprise of dolutegravir is GlaxoSmithKline, with the original brand name Tivicay. The core compound patent expired in 2027 in the European and American markets, and the compound patent in China expired in 2023. The main dosage form approved for the original drug is tablet, with a conventional specification of 50mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation listed by the FDA. In terms of domestic API registration, more than 10 enterprises including the original research manufacturer have obtained CDE associated review and approval (A status) for dolutegravir APIs. A number of domestic generic dolutegravir single-agent and combination products have been approved for marketing, which can fully meet the clinical medication demand. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for dolutegravir. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They can meet the compliance requirements for quality research under multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and provide stable and reliable reference standard support for R&D and production links of pharmaceutical enterprises such as API quality control and consistency evaluation.