Ibandronic

Osteoporosis has become a highly prevalent bone metabolic disease among the middle-aged and elderly population worldwide. Complications such as bone pain and hypercalcemia caused by bone metastasis of malignant tumors even severely affect the quality of life of patients. Ibandronic acid is a third-generation bisphosphonate drug. It specifically binds to hydroxyapatite in bone tissue, inhibits osteoclast activity, reduces bone resorption and bone destruction, and also reduces the adhesion ability of tumor cells to bone matrix, with both bone protection and indirect anti-tumor effects. Clinically, it is mainly used for the prevention and treatment of osteoporosis in postmenopausal women, the prevention of bone events related to bone metastasis of malignant tumors, and the treatment of hypercalcemia caused by malignant tumors. The applicable population covers middle-aged and elderly osteoporosis patients and patients with advanced solid tumor bone metastasis.

The global market size of ibandronic acid was approximately USD 420 million in 2023. Driven by the rising prevalence of osteoporosis and the growing demand for bone metastasis intervention driven by the popularization of early cancer screening, the compound annual growth rate is expected to remain at 3.8% from 2024 to 2030. In terms of the domestic market, the sales of ibandronic acid in sample hospitals were approximately RMB 310 million in 2023. Currently, the market is dominated by generic drugs, with original research products accounting for less than 15%. There are more than 7 generic enterprises that have passed the consistency evaluation, and the drug has been included in the fifth batch of national centralized drug procurement. The average price reduction of selected products exceeds 70%, and clinical accessibility has been greatly improved.

The original research enterprise of ibandronic acid is Roche, and the original trade name is "Bondronat". The core compound patent of ibandronic acid expired in 2005 and 2006 in the United States and the European Union respectively, and the Chinese compound patent expired in 2004. The marketed dosage forms of the original research include injections (1mg/1ml, 6mg/6ml) and oral tablets (150mg). Both the injection and the tablet have been included in the Chinese Listed Drug Catalogue as reference preparations, and are also included in the FDA Reference Preparation Catalogue. As of June 2025, there are 12 registration records of ibandronic acid API on the API Registration Platform of China National Medical Products Administration Center for Drug Evaluation (CDE), among which 8 are in Status A. Multiple domestic enterprises have obtained approval for the marketing of ibandronic acid injections and tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of ibandronic acid impurity reference standards, covering all categories such as process impurities and degradation impurities. Most products are available from 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 use needs of different stages such as API research and development, quality research, and registration and declaration.