Clodronate Disodium

Bone metastasis is a common complication of malignant tumors. Approximately 70% of patients with advanced breast cancer and prostate cancer will experience bone-related events such as bone pain and pathological fractures, which seriously affect the quality of life of patients. Clodronate disodium belongs to the first-generation bisphosphonate drugs. It specifically binds to hydroxyapatite in bone tissue, inhibits the activity and proliferation of osteoclasts, reduces the process of bone resorption, and can lower the blood calcium concentration at the same time. Clinically, it is mainly used for the treatment of hypercalcemia caused by malignant tumors and bone pain caused by osteolytic cancer metastasis. It can also avoid or delay osteolytic bone metastasis of malignant tumors, and has definite therapeutic effects on various types of osteoporosis. The applicable population covers solid tumor patients at risk of bone injury and patients with primary/secondary osteoporosis.

The global market size of clodronate disodium maintains a steady growth trend. In 2023, the global market size was approximately USD 320 million, with a compound annual growth rate of around 4.2%. In terms of the domestic market, with the extension of the survival period of tumor patients and the increase in the prevalence of osteoporosis, the domestic market size of clodronate disodium preparations in 2023 was approximately RMB 680 million, with a compound annual growth rate of 6.7%. At present, the domestic market is dominated by generic drugs, and the market share of original research products has dropped to around 23%. More than 12 domestic enterprises have been approved to produce clodronate disodium preparations. After the centralized procurement, the price of preparations has dropped by more than 70%, which has further driven the improvement of the accessibility of clinical medication, and the demand for upstream API has also continued to expand.

The original research enterprise of clodronate disodium is Bayer Pharma, and the original research brand name is "Bonefos". The core compound patent expired in Europe and the United States in 2006, and the compound patent in China expired in 2008. The main dosage forms approved for the original research product include capsules (specification: 400mg) and injection (specification: 5ml:300mg). Both the original research capsules and injection have been included in the China Listed Drug Catalogue and are used as reference preparations. As of now, there are 9 registration entries of clodronate disodium API on the API registration platform of China CDE, among which 7 are in the status of "A (approved for use in marketed preparations)". More than 10 clodronate disodium preparation varieties have been approved for marketing in China, covering two dosage forms: capsules and injections. (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 clodronate disodium. Most of the products are in stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the impurity control needs in the process of API R&D, quality research and production.