Oxymetazoline

As a commonly used drug in the field of nasal and ocular decongestion therapy, oxymetazoline is an α-adrenergic receptor agonist. It can rapidly constrict local mucosal blood vessels, reduce vascular exudation, and relieve mucosal congestion and edema by activating the α1 receptor on vascular smooth muscle, thereby alleviating symptoms such as nasal congestion and conjunctival congestion. It is mainly used clinically to improve nasal congestion caused by allergic rhinitis, acute and chronic rhinitis, and sinusitis, as well as to relieve ocular congestion caused by allergic conjunctivitis and visual fatigue. It is applicable to adults and children over 6 years old. With rapid onset of effect after local administration and a duration of action of 6 to 8 hours, it is one of the first-line options for clinical symptomatic treatment.

The global market size of oxymetazoline preparations was approximately USD 870 million in 2023, and it is expected to grow steadily at a compound annual growth rate of 3.2% from 2024 to 2030. The demand growth is mainly driven by the rising prevalence of allergic diseases and the improved accessibility of over-the-counter drugs. The domestic market is dominated by generic drugs. At present, more than 30 enterprises have obtained preparation approvals, with nasal drops and sprays being the main circulating dosage forms. Since 2022, provincial-level centralized procurement in multiple regions has included oxymetazoline nasal preparations in the procurement scope, with an average price reduction of approximately 46% for winning bids, which has further driven the continuous expansion of upstream API demand.

The original research enterprise of oxymetazoline is Novartis, with the original brand names "Ocuclear" (ophthalmic preparation) and "Otrivin Oxy" (nasal preparation). The core compound patent of oxymetazoline expired globally around 1970. At present, the main dosage forms of the original research product on the market include 0.025% and 0.05% nasal sprays and nasal drops, as well as 0.025% eye drops. Relevant dosage forms have been included in the FDA Reference Listed Drug Catalog, and no original research preparation has been approved for marketing in China yet. According to the domestic API registration platform, 5 enterprises have obtained A-status registration numbers for oxymetazoline APIs, which can meet the requirements of associated review for domestic preparation production. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for oxymetazoline API, and most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can cover the reference standard use needs in the whole process of API R&D, quality research and registration, providing stable material basis support for the R&D and production links of relevant enterprises.