Bazedoxifene Acetate

Postmenopausal osteoporosis is one of the core threats to the bone health of middle-aged and elderly women. Although traditional hormone replacement therapy can improve bone mineral density, it carries the risk of reproductive system tumors, and there is an urgent clinical need for safer targeted treatment options. Bazedoxifene belongs to the third generation of selective estrogen receptor modulators (SERMs). It can exert estrogen-like bone protective effects by binding to estrogen receptors in bone tissue with high selectivity, while showing estrogen antagonistic effects in breast and endometrial tissues, avoiding the safety risks of traditional hormone therapy. This drug is mainly used for the prevention and treatment of osteoporosis in postmenopausal women. It can significantly reduce the risk of vertebral fractures, has a certain improvement effect on blood lipid metabolism, and is suitable for patients who are intolerant to bisphosphonate drugs.

At present, the global number of patients with postmenopausal osteoporosis has exceeded 200 million, driving the continuous expansion of the bazedoxifene-related market. In 2023, the global market size was approximately USD 420 million, with a compound annual growth rate of around 7%. In terms of the competitive landscape, the original research product still occupies the main market share, and only a small number of domestic enterprises have completed generic drug applications. With the improvement of osteoporosis screening rate and the enhancement of medication awareness among the age-appropriate population, the domestic generic drug substitution space is expected to exceed RMB 1.5 billion.

The original research enterprise of bazedoxifene is Pfizer, with the original brand name Evista. The core compound patents expire in 2023 and 2024 in Europe and the United States respectively, and the compound patent in China expired in 2022. The main dosage form of the original product is oral tablet, with a conventional specification of 60 mg, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (9th Batch)*. In terms of domestic API registration, as of now, the bazedoxifene APIs submitted by 3 enterprises have passed the review and public announcement of CDE (status A), and a total of 5 enterprises have obtained marketing approval for bazedoxifene tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

The development and quality control of generic bazedoxifene involve the qualitative and quantitative research of multiple key impurities. CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and in-stock orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of pharmaceutical enterprises in different scenarios such as drug research and development and quality inspection.