Lamivudine

Chronic hepatitis B is a globally prevalent infectious disease. Long-term viral replication will gradually induce liver fibrosis, liver cirrhosis and even hepatocellular carcinoma, and there has been an urgent clinical need for safe and effective antiviral interventions for a long time. Lamivudine is a nucleoside reverse transcriptase inhibitor, which can highly effectively inhibit hepatitis B virus replication by competitively inhibiting the activity of hepatitis B virus DNA polymerase and terminating the extension of viral DNA chains. Meanwhile, it can also be used in combination with other antiretroviral drugs for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children. It is the first oral nucleoside drug in the field of antiviral therapy for chronic hepatitis B, which greatly improved the long-term prognosis of hepatitis B patients in the initial stage of its launch.

In recent years, the global market size of lamivudine preparations has remained at around USD 420 million. As one of the main application regions of lamivudine, the Chinese market has a market size of approximately RMB 860 million. Due to its early launch, the patents of this variety have fully expired. At present, the global market is dominated by generic drug supplies. There are more than 30 domestic manufacturers of lamivudine preparations that have been approved, among which 19 enterprises have their relevant varieties passed or deemed to have passed the consistency evaluation. This variety has been included in the national centralized volume-based procurement, and the winning bid price has dropped by more than 90% compared with that before the centralized procurement, greatly improving the clinical accessibility.

The original research enterprise of lamivudine is GlaxoSmithKline, and the original brand name is "Heptodin". The expiration date of its core compound patent in the United States is 2006, and the compound patent in China expired in 2006. The main dosage form approved by the original research is tablet, with a specification of 100mg. This specification has been included in the China Listed Medicines Catalog as the reference preparation, and is also included in the FDA Reference Preparation Catalog. According to the domestic API registration platform, there are currently 28 lamivudine API registration records, among which 24 have passed the A-status publicity. The domestically approved lamivudine preparations cover multiple dosage forms such as tablets, capsules and oral solutions. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for lamivudine API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in drug R&D, quality research and production links.