Desogestrel

The contraceptive needs of women of childbearing age worldwide have long existed, and steroidal hormone contraceptives with both effectiveness and safety are one of the first-choice clinical solutions. Desogestrel is a third-generation highly selective progestogen, which has strong affinity for progestogen receptors and almost no androgenic activity. It inhibits ovulation by suppressing the secretion of pituitary gonadotropin, while changing the viscosity of cervical mucus to hinder sperm penetration and inhibiting endometrial growth to hinder the implantation of fertilized eggs. It is often combined with ethinylestradiol to form compound oral contraceptives for female contraception, and can also be used to treat progestogen-related gynecological diseases such as dysfunctional uterine bleeding and polycystic ovary syndrome, which is suitable for women of childbearing age with long-term contraceptive needs or related gynecological disease treatment needs.

The global market size of compound oral contraceptives is stably above US$19 billion, among which desogestrel-containing preparations account for about 22% of the market share of third-generation oral contraceptives. Driven by the improvement of women's reproductive health awareness in recent years, the annual compound growth rate of the Chinese market has remained at 6.8%. At present, the competitive landscape of this variety is dominated by generic drugs. The global production capacity of APIs is mainly concentrated in China and India, and many domestic enterprises have been approved for generic drug preparations. With the advancement of the centralized procurement policy, the price decline of related preparations has further driven the growth of demand for upstream APIs.

The original research enterprise of desogestrel is Organon (later acquired by MSD), and the original research trade name is "Marvelon". Its core compound patents in major markets such as Europe and the United States expired around 2008, and the Chinese compound patent has also passed the protection period. The main dosage form approved for the original research is oral tablet, with the specification of desogestrel 0.15mg + ethinylestradiol 30μg, which has been included in the Chinese *Catalogue of Chemical Reference Preparations* and also listed as a reference preparation by the FDA. Up to now, a number of enterprises' desogestrel APIs have been registered in Status A on the API registration platform of China's CDE, and a number of compound desogestrel 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 desogestrel impurity reference standards, most of which are in stock. Orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of the whole process of API R&D, quality research, registration and declaration, etc.