Naphazoline

Mucosal hyperemia diseases such as allergic rhinitis and conjunctivitis are high-incidence common respiratory and ophthalmic diseases, and there has been a long-term lack of targeted drugs for rapid relief of local symptoms, while the clinical application of naphazoline has filled the demand gap in this market segment. As an α-adrenergic receptor agonist belonging to imidazoline derivatives, it can directly stimulate the α1 receptors on blood vessels, rapidly contract blood vessels in the nasal mucosa, conjunctiva and other parts, reduce local hyperemia and exudation, so as to quickly relieve discomfort symptoms such as nasal congestion, eye itching, conjunctival redness and swelling. It is clinically mostly used for the symptomatic treatment of allergic rhinitis, acute and chronic rhinitis, inflammatory ocular hyperemia and other diseases, and the applicable population covers adults and pediatric patients under compliant dosage.

At present, the global naphazoline market size is about USD 120 million, and the compound annual growth rate from 2023 to 2028 is expected to remain at around 3.2%. The growth momentum mainly comes from the demand expansion of retail channels such as over-the-counter nasal sprays and eye drops. In the domestic market, this variety has been included in the Class B medical insurance catalog, and the preparation side is dominated by generic drugs. The supply of API is currently mainly concentrated in characteristic API enterprises in North China and East China, and there is no monopoly pattern of a single dominant enterprise. With the increase in the allocation rate of nasal and ophthalmic drugs in primary medical institutions in recent years, the domestic demand for API maintains a stable growth rate of about 4% per year.

The original research enterprise of naphazoline is Novartis, with the original brand name Naphcon, and its core compound patent expired worldwide in 1980. At present, the mainstream approved dosage forms include nasal drops and eye drops, with common specifications of 0.05% and 0.1% concentrations, and the original research preparation has been included in the FDA Reference Listed Drug Catalog. For the domestic market, 11 enterprises have obtained CDE registration numbers for naphazoline API, all of which are in activated status (Status A). More than 30 approval documents for the corresponding generic nasal drops and eye drops have been approved for marketing, and no imported original research preparation has been approved in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

For the impurity research needs in the process of generic drug development and consistency evaluation of naphazoline, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia and FDA, and can directly support impurity qualitative and quantitative research and submission of declaration materials.