Drospirenone

The escalating demand for contraception among women of childbearing age globally is driving the R&D iteration of progestogen drugs, and drospirenone is a representative variety of the fourth-generation progestogens. As a 17α-spirolactone derivative, it achieves contraceptive effects by inhibiting ovulation and changing the viscosity of cervical mucus. Meanwhile, it has antimineralocorticoid activity, which can alleviate common adverse reactions of traditional progestogens such as water and sodium retention and weight gain. It can also antagonize androgens and improve symptoms of acne and hirsutism. In addition to the indication of routine contraception, compound preparations containing drospirenone have also been approved for the treatment of moderate acne vulgaris and premenstrual dysphoric disorder, making them one of the highly recognized progestogen drugs in clinical practice at present.

The global drospirenone market size was approximately USD 1.27 billion in 2023, and it is expected to grow steadily at a compound annual growth rate of 4.2% from 2024 to 2030. In terms of the domestic market, the sales of drospirenone-containing preparations in public medical institutions and retail terminals exceeded RMB 2.2 billion in 2023. With the improvement of contraception awareness among young groups and the expansion of relevant indications, there is still considerable room for demand release. In the current competitive landscape, original research products occupy a dominant position, and multiple domestic enterprises have laid out generic drugs. Since 2023, 3 generic drospirenone compound preparations have been approved for marketing, and the dynamic adjustment of relevant centralized procurement catalogs will further promote the optimization of the market structure.

The original research enterprise of drospirenone is Bayer Pharma, and the relevant preparations are sold under the trade names Yasmin, Yaz, etc. The core compound patent of drospirenone expired around 2021 in major markets such as the United States and Europe, and the Chinese compound patent also expired in 2021. The marketed original research preparations are mainly compound oral tablets, with specifications including 3mg drospirenone + 0.03mg ethinylestradiol and 3mg drospirenone + 0.02mg ethinylestradiol. The original research preparation of this variety has been included in the *Reference Preparation Catalog of Chemical Drugs* issued by the National Medical Products Administration. At present, more than 10 domestic enterprises have obtained CDE registration numbers for drospirenone API, many of which are in status A and can support associated review. A number of domestic drospirenone compound preparations have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of drospirenone API, 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, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of various R&D scenarios such as impurity research and quality standard establishment.