Ospemifene

Moderate to severe dyspareunia associated with menopause is a common manifestation of genitourinary syndrome that troubles menopausal women. Its core pathogenesis is directly related to vaginal epithelial atrophy and mucosal thinning caused by decreased estrogen levels. As the world's first oral selective estrogen receptor modulator, ospemifene exerts estrogen-like effects in vaginal tissues to promote the proliferation of vaginal epithelial cells, increase mucus secretion, and lower vaginal pH, while exhibiting anti-estrogen activity in tissues such as the mammary gland and endometrium, thus avoiding the potential safety risks of traditional hormone replacement therapy. It is mainly used for the treatment of dyspareunia caused by moderate to severe vulvovaginal atrophy in postmenopausal women, providing a new non-invasive treatment option for patients intolerant to topical medications.

The current global market size of ospemifene is approximately USD 320 million, with a compound annual growth rate of around 4.7% in the past three years. The growth momentum mainly comes from the expansion of the global menopausal women population and the increasing clinical recognition of non-hormonal treatment regimens. In terms of the competitive landscape, the original research product still accounts for more than 85% of the global market share at present. The Chinese market is currently in the stage of generic drug layout, and no domestic generic drug has been launched yet. With the annual increase in the consultation rate of menopausal-related symptoms among domestic women of childbearing age, the future clinical demand and market space of this variety are expected to be further released.

The original research enterprise of ospemifene is Shionogi Pharma Co., Ltd. of Japan, with the original brand name Osphena. Its US compound patent will expire in 2027, and the Chinese compound patent expired in 2023. The main approved dosage form of the original research product is tablet with a specification of 60 mg, which has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the *Catalog of Reference Preparations for Chemical Drugs* of China. In terms of domestic API registration, there is currently no approved ospemifene API registration number with A status. Only one enterprise has submitted an API registration application which is under review and approval, and no ospemifene preparation has been approved for marketing in China yet. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the demand for generic drug research and development and quality control of this variety, CATO can provide a full set of ospemifene impurity reference standards. Most of the products are available from stock, and in-stock products ordered before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of various scenarios such as impurity qualitative and quantitative analysis and methodological validation in the research and development process.