Minodronic

Osteoporosis is a metabolic bone disease with high incidence among middle-aged and elderly populations. As the global population aging process accelerates, the clinical demand for anti-bone resorption drugs with high efficacy and low toxicity continues to rise. Minodronic acid belongs to the third-generation nitrogen-containing bisphosphonate drugs. It specifically inhibits the activity of farnesyl pyrophosphate synthase in osteoclasts and blocks the proliferation and differentiation of osteoclasts, thereby reducing the bone resorption rate and increasing bone mineral density. It is currently a first-line clinical drug for the treatment of osteoporosis in postmenopausal women and male osteoporosis, and can also be used to improve hypercalcemia and bone pain symptoms caused by bone metastasis of malignant tumors. Its medication convenience and tolerability are superior to those of previous generations of bisphosphonate products.

The global market size of minodronic acid exceeded USD 420 million in 2023, with a compound annual growth rate of 7.8% in the past five years. The Asia-Pacific region is the region with the fastest growth rate, with an annual growth rate of 11.2%. In terms of the competitive landscape, the original research product still accounts for about 45% of the share in major markets such as Japan and China. With the expiration of core patents, the generic drug market has entered a stage of rapid expansion. At present, 3 Chinese enterprises have obtained marketing approval for minodronic acid preparations, and the localization rate of APIs has exceeded 60%. The winning bid price in the centralized procurement of public medical institutions has dropped by about 72% compared with the original research product, further improving clinical accessibility.

The original research enterprise of minodronic acid is Ono Pharmaceutical Co., Ltd. of Japan, with the original brand name "Bonoteo". Its core compound patent expired in 2022 in Japan and in 2021 in China. The original dosage form is tablet, with specifications of 1mg and 0.5mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs (8th Batch)* of China, and is also listed in the FDA Reference Preparation Catalogue. Up to now, the Center for Drug Evaluation of China has registered 12 registration numbers for minodronic acid APIs, among which 8 are in status A (approved for use in marketed preparations). Dosage forms such as minodronic acid tablets and dispersible tablets have been approved for marketing in China. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the demand for impurity reference standards in the R&D and quality control links of minodronic acid, CATO provides a full set of impurity reference standards for this API, covering all categories such as process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can directly support API registration and declaration, quality research and routine release testing.