Conjugated Estrogens

Postmenopausal women are prone to a series of health problems such as osteoporosis and vasomotor syndrome, and hormone replacement therapy is one of the core clinical solutions to improve these symptoms. Conjugated estrogens are natural conjugated estrogen drugs composed of more than ten estrogen derivatives. They exert their effects by binding to estrogen receptors and can supplement the deficiency of endogenous estrogens. They are mainly used for the treatment of moderate to severe menopause-related vasomotor symptoms and vulvovaginal atrophy, while preventing postmenopausal osteoporosis. They can also be used for hormone replacement therapy in patients with primary ovarian insufficiency, and the applicable population is mainly postmenopausal women and female patients with estrogen deficiency.

The global market size of conjugated estrogens is approximately USD 1.2 billion, with a compound annual growth rate maintained at around 3.2%. The growth momentum mainly comes from the expansion of the global postmenopausal female population and the increased awareness of hormone replacement therapy. The current domestic market is dominated by the original research product. With the advancement of the consistency evaluation of generic drugs, generic preparations from 3 enterprises have been approved for marketing, with their price approximately 40% lower than that of the original research product, and the proportion of procurement volume in public medical institutions has increased to 27%.

The original research enterprise of conjugated estrogens is Pfizer, and the original research trade name is Premarin. Its core compound patent expired in 1999, and the preparation patents in the major markets of China and the United States have all expired comprehensively. The main dosage forms of the original research product include tablets, injections and creams. The common specifications of tablets are 0.3mg, 0.625mg and 1.25mg, and the specification of cream is 1g:0.625mg. The original research tablets and creams have been included in the China Listed Medicines Catalogue as reference preparations, and are also included in the FDA Reference Preparations Catalogue. Up to now, there are a total of 6 conjugated estrogen registration entries on the API registration platform of China CDE, among which 2 are in A status, which can support the domestic marketing declaration of preparations. Multiple dosage forms of conjugated estrogen preparations have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for conjugated estrogen API. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most varieties are in stock. In-stock orders placed before 16:00 can be shipped on the same day, which can fully meet the use needs of the whole process of drug research and development, quality research and release testing.