Ulipristal

As an important intervention in the field of reproductive health, the effective window of traditional progestogen drugs for emergency contraception is usually limited to 72 hours after unprotected sexual intercourse, while the launch of ulipristal has filled the clinical gap of contraception with a longer time window. As a selective progesterone receptor modulator, it exerts contraceptive effects by competitively binding to progesterone receptors, inhibiting ovulation and changing the state of the endometrium. Meanwhile, it can also be used for symptomatic preoperative treatment of uterine fibroids. Its core advantage is that it can still maintain stable contraceptive effect when taken within 120 hours after unprotected sexual intercourse, which greatly reduces the risk of unintended pregnancy and provides women of childbearing age with more flexible contraceptive options.

In the global emergency contraceptive market, the proportion of ulipristal-related products is continuously increasing. The global market size exceeded 420 million US dollars in 2023, with a compound annual growth rate of 8.7% in the past three years. At present, Europe and North America are the main consumer markets of this variety. Domestic generic drug R&D is in the stage of rapid advancement, and there is no mature large-scale generic drug on the market. The market supply is still dominated by original research products. With the increase of reproductive health needs of domestic childbearing groups, there is a large room for improvement in the domestic market penetration rate of ulipristal.

The original research enterprise of ulipristal is Laboratoire HRA Pharma, and the original trade name is EllaOne. Its core compound patent in the EU region expired in 2020, and the core patent in the US region expired in 2021. The main dosage form approved by the original research is tablet, with a specification of 30mg. This dosage form has been included in the FDA Reference Listed Drug Catalog, and also included in the EU List of Marketing Authorized Medicinal Products. There is no ulipristal preparation product approved for marketing in China, and no valid A-status registration number has been found on the API registration platform for the time being. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of ulipristal impurity reference standards, support full-process traceability verification, and can meet the quality research requirements under multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most impurity products are in regular stock. In-stock products with orders submitted before 16:00 can be shipped on the same day, which can fully meet the reference standard supply needs of pharmaceutical enterprises in the process of generic drug R&D and quality consistency evaluation.