Tenofovir disoproxil

The long-term prevention and control of chronic viral infectious diseases such as chronic hepatitis B and AIDS has always relied on antiviral drugs with high barrier and low drug resistance to support clinical treatment regimens. Tenofovir disoproxil is a nucleoside reverse transcriptase inhibitor. After entering cells, it is phosphorylated to generate the active metabolite tenofovir diphosphate, which competitively binds to natural deoxyribose substrates and inserts into the viral DNA chain to terminate chain extension, thereby inhibiting the replication of hepatitis B virus (HBV) and human immunodeficiency virus (HIV). This drug is a first-line recommended drug for treatment-naive patients with chronic hepatitis B, and can also be used in combination with other antiretroviral drugs for the treatment of HIV infection in adults and adolescents over 12 years old. Due to its low drug resistance rate and good safety, it has been included in the core antiviral drug list by guidelines of many countries.

The global market size related to tenofovir disoproxil had exceeded USD 3.8 billion in 2023. Although the massive launch of generic drugs after the expiration of core patents has lowered the overall market growth rate, driven by the expansion of demand for hepatitis B and HIV prevention and control in low- and middle-income countries, the compound growth rate in the past three years has remained at 4.2%. China is the core supplier of tenofovir disoproxil active pharmaceutical ingredients (APIs) in the world. More than 30 domestic enterprises have obtained approval for the marketing of generic drug preparations. After the volume-based procurement, the terminal price of preparations has dropped by more than 90%. The API market competition presents a pattern of "dominated by large-scale enterprises, with cost control as the core competitive factor", and the production capacity of leading enterprises accounts for more than 60%.

The original research enterprise of tenofovir disoproxil is Gilead Sciences, and the original trade name is "Viread". Its core compound patent in the United States expired in 2017, and the compound patent in China expired in 2018. The main dosage form approved for the original research drug is tablet, with a specification of 300mg, which has been included in the Chinese Catalogue of Reference Preparations for Chemical Drugs and the FDA Reference Preparation Catalogue. As of the retrieval time point, there are a total of 69 registration records of tenofovir disoproxil APIs on the API registration platform of China National Medical Products Administration Center for Drug Evaluation (CDE), among which 56 have been publicized in Status A, and more than 30 domestic enterprises have obtained approval for the marketing of tenofovir disoproxil preparations. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for tenofovir disoproxil APIs. Most products are in regular stock. Spot orders paid before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully support the full-process needs of pharmaceutical enterprises in API quality research, preparation stability study and registration declaration.