Ipriflavone

Osteoporosis is a degenerative bone disease with a high incidence among the middle-aged and elderly population. Its core pathogenesis is closely related to insufficient osteoblast activity and excessive activation of osteoclast function. Ipriflavone, an isoflavone derivative, is a commonly used anti-osteoporosis drug in clinical practice with a unique mechanism of action: on the one hand, it can directly promote the proliferation and differentiation of osteoblasts to improve bone formation efficiency; on the other hand, it can inhibit the bone resorption activity of osteoclasts. Meanwhile, it can also cooperate with estrogen to regulate bone metabolism without the risk of reproductive system adverse reactions associated with estrogen drugs. Clinically, it is mainly used to improve the symptoms of bone pain and bone mass loss caused by primary osteoporosis and perimenopausal osteoporosis. The applicable population covers high-risk groups of osteoporosis such as the middle-aged and elderly, postmenopausal women, etc. Long-term application can significantly reduce the risk of fracture.

The current global market size of ipriflavone is stable at around USD 120 million. Driven by the global population aging process, the compound annual growth rate remains at 3.7%, among which the Asia-Pacific region is the core consumer market, accounting for 62% of the total global demand. In terms of the domestic market, the drug has been included in the local medical insurance catalogs of some regions, with an overall market size of approximately RMB 180 million. Generic drugs occupy more than 90% of the market share, and the supply of API is mainly dominated by local enterprises. There is no record of the implementation of relevant centralized procurement so far.

The original research enterprise of ipriflavone is Takeda Pharmaceutical Company Limited of Japan, with the original brand name "Osten". The core compound patent expired in 2001 in major markets such as Japan and the United States. The main dosage form of the original marketed product is tablet, with a conventional specification of 200 mg per tablet, which has been included in the Pharmaceutical Products List of the Ministry of Health, Labour and Welfare of Japan and the Reference Listed Drug Catalog of the US FDA. In China, as of now, the ipriflavone APIs of more than 15 enterprises have been registered through the CDE platform and obtained the Class A status label, and the ipriflavone tablets and capsules of more than 20 other enterprises have obtained domestic marketing approval. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a complete set of impurity reference standards for ipriflavone API. The products strictly meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most products are in regular stock. Spot orders placed before 16:00 can be shipped on the same day, which can fully meet the needs of pharmaceutical enterprises in various R&D and production scenarios such as impurity research and quality standard establishment.