Etonogestrel

Long-acting reversible contraception is a key development direction in the global reproductive health field. As a third-generation progestogen API, etonogestrel inhibits ovulation by suppressing the secretion of pituitary gonadotropin, and at the same time changes the viscosity of cervical mucus to block sperm penetration, achieving highly effective contraception through a dual mechanism. Its contraceptive effective rate can reach over 99%, the duration of action is as long as 3 years, and fertility can be restored quickly after the implant is removed. It is especially suitable for women of childbearing age who have long-term contraception needs and are intolerant to estrogen drugs. At present, it is also gradually applied in the exploration of treatment for gynecological diseases such as abnormal uterine bleeding and endometriosis.

The global market size of etonogestrel-related preparations was approximately USD 1.28 billion in 2023, with a compound annual growth rate of 6.2% from 2019 to 2023. The growth momentum mainly comes from the increasing penetration rate of long-acting contraceptive products in emerging markets and the expanding demand for non-surgical treatment of gynecological diseases. In terms of the competitive landscape, the original research product still accounts for about 68% of the global market share. In recent years, generic preparations from Chinese and Indian pharmaceutical companies have gradually obtained WHO prequalification and entered the international public procurement market. The domestic market is currently in the initial stage of substitution where the original research product dominates and generics are gradually approved, and there is no public data related to centralized procurement.

The original research enterprise of etonogestrel is Organon, and the original research trade name is Implanon. The core compound patent expired in the United States in 2020, and the core European patent expired in 2019. The main dosage form of the original research product is subcutaneous implant, with a specification of 68mg etonogestrel per implant. This original research implant has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also listed in the FDA Reference Preparation Catalogue. The domestically marketed preparations include the original research Implanon and 2 domestic generic implants. There are currently 3 etonogestrel API registration numbers on the CDE API registration platform, of which 2 are in the status of "A" (approved for use in marketed preparations) and 1 is in the status of "I" (not yet passed the joint evaluation and approval with preparations). (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of etonogestrel impurity reference standards, covering all research needs such as synthesis process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed 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 full-process R&D needs of pharmaceutical enterprises such as API quality research, preparation stability investigation, and registration declaration.