Dydrogesterone

Progesterone deficiency is one of the core inducing factors leading to female reproductive endocrine diseases such as threatened abortion, menstrual disorder and endometriosis. As an oral progestogen drug, dydrogesterone binds to progesterone receptor with high selectivity, which can not only simulate the physiological effect of endogenous progesterone, but also does not affect the secretion levels of estrogen, androgen and adrenocortical hormone in the body, and has no obvious adverse reactions such as drowsiness and mood swings. Clinically, it is mainly used to treat dysmenorrhea, secondary amenorrhea and dysfunctional uterine bleeding caused by endogenous progesterone deficiency. It can also be used for threatened abortion or habitual abortion caused by progesterone deficiency, and infertility caused by luteal insufficiency. The applicable population covers women from childbearing age to perimenopause with progesterone deficiency related diseases. Compared with natural progesterone, it has higher oral bioavailability and better clinical compliance.

At present, the global market size of dydrogesterone is about USD 1.2 billion, with an average annual compound growth rate of about 4.7% in the past three years. China is one of the fastest growing markets in the world, with an annual market size exceeding RMB 1.8 billion and an average annual growth rate of more than 8%. At present, the original research products still dominate the domestic market, accounting for more than 65%. With the acceleration of domestic generic drug R&D progress, dydrogesterone tablets of 3 enterprises have passed the consistency evaluation. After the implementation of centralized procurement, the market gradually tilts to generic enterprises with cost advantages, and the gap in upstream API supply has expanded accordingly.

The original research enterprise of dydrogesterone is Abbott Biologicals B.V. in the Netherlands, with the trade name Duphaston®. Its core compound patent expired globally in 2007. The domestically approved original research dosage form is tablet, with a specification of 10mg, which has been included in the China Listed Drug Catalogue as a reference preparation. In terms of domestic API registration, there are currently 7 dydrogesterone API registration numbers including those of the original research enterprise, among which 5 are in registration status A (approved for use in marketed preparations), and another 11 domestic dydrogesterone tablet 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 provides a full set of dydrogesterone impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of the whole process of API R&D, quality research and registration declaration.