Norelgestromin

In the development process of long-acting contraceptive drugs for women, the iteration of progestogen components has always centered on the balance between contraceptive effectiveness and user compliance. As a third-generation synthetic progestogen, norelgestromin has the dual characteristics of high progestogen receptor affinity and low androgenic activity. It can inhibit ovulation, change the viscosity of cervical mucus to block sperm penetration, and adjust the state of the endometrium to prevent fertilized egg implantation. Clinically, it is mainly used to prepare long-acting contraceptive preparations such as transdermal contraceptive patches and long-acting contraceptive implants, and is suitable for women of childbearing age who have long-term contraceptive needs and poor compliance with daily oral medications. Compared with traditional oral contraceptives, it can effectively reduce the risk of contraceptive failure caused by missed doses.

The global long-acting contraceptive drug market has maintained a steady expansion trend in recent years, with the market size exceeding US$12 billion in 2023. Among them, the compound annual growth rate of non-oral dosage forms such as transdermal contraceptives and implants reaches 7.2%, which is significantly higher than the growth rate of oral contraceptives. As the core active pharmaceutical ingredient of long-acting contraceptive preparations, the current global supply side of norelgestromin is dominated by European and American original research and generic drug manufacturers. There are no domestic enterprises with large-scale production in China at present, and clinical preparations and related active pharmaceutical ingredients are still highly dependent on imports. With the continuous improvement of the acceptance of long-acting contraception among the domestic childbearing population, the market demand for this variety is showing an increasing trend year by year.

The original research enterprise of norelgestromin is Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and the original research trade name is Evra. Its transdermal patch product was first approved for marketing by the FDA in 2002. The core compound patent of this variety expired globally in 2019. At present, the main dosage form on the market is transdermal patch, with specifications of 6 mg norelgestromin and 0.75 mg ethinylestradiol per patch. The original research transdermal patch has been included in the FDA Reference Listed Drug Catalog, and has not yet been included in the *Catalog of Reference Preparations for Chemical Drugs* of China. As of the retrieval time point, the API Registration Platform of China Center for Drug Evaluation (CDE) has not yet included a valid registration number for norelgestromin, and no preparation of this variety has been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for norelgestromin. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet various use needs in the stages of API research and development, quality research and declaration.