Estradiol Valerate

Estrogen deficiency-related diseases such as menopausal syndrome and ovarian insufficiency are high-incidence problems affecting the quality of life of middle-aged and elderly women, and hormone replacement therapy is commonly used clinically to improve the related symptoms. Estradiol valerate is an ester derivative of the natural estrogen estradiol, which can be rapidly metabolized into estradiol after entering the human body. By binding to estrogen receptors, it supplements the deficiency of endogenous estrogen. It can not only relieve menopause-related symptoms such as hot flashes and night sweats, sleep disorders, and vaginal dryness, but also be used in combination with progestogen to establish an artificial menstrual cycle, and can also be used to prevent osteoporosis caused by estrogen deficiency. The applicable population covers women with estrogen deficiency caused by natural menopause or surgical menopause, as well as some patients with hypogonadism.

The global estrogen replacement therapy market has maintained steady growth in recent years. Among them, estradiol valerate, as one of the preferred natural estrogen API for clinical use, had a global market size of approximately USD 180 million in 2023, with a compound annual growth rate maintained at around 4.2%. Driven by the aging process and the improvement of women's health management awareness in the domestic market, the demand growth rate has reached 6.7% in the past three years. Currently, the competitive landscape is dominated by generic drug manufacturers, with the original research product accounting for approximately 23% of the market share. More than 10 domestic enterprises have obtained preparation approvals, and the localization rate of API has exceeded 70%.

The original research enterprise of this variety is Bayer Healthcare, and the original research trade name is "Progynova". The core compound patent expired globally in 2005. The mainstream dosage form of the original research is oral tablet, with two conventional specifications of 1mg and 2mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and also included in the FDA Reference Preparation Catalogue. According to the domestic API registration platform, there are currently 12 registration numbers of estradiol valerate API, 8 of which are in A status and can be legally supplied for domestic preparation production, and a number of domestic preparation varieties have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for estradiol valerate. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide reliable reference material support for the quality research, stability study, impurity control and other links of API and preparation manufacturers.