Ozenoxacin

For the diagnosis and treatment of skin infections caused by sensitive bacteria, quinolone topical drugs have become the mainstream choice for diseases such as bacterial dermatitis and impetigo by virtue of their advantages of strong targeting and low systemic exposure. As a fourth-generation quinolone topical antibacterial agent, ozenoxacin inhibits the activity of bacterial DNA gyrase and topoisomerase IV, blocks the process of bacterial DNA replication and transcription, and has strong antibacterial activity against a variety of Gram-positive bacteria such as Staphylococcus aureus and Streptococcus pyogenes, as well as some Gram-negative bacteria and anaerobic bacteria. It is mainly used for the local treatment of bacterial skin infections such as impetigo and secondary infection of eczema in people aged 2 years and older. Compared with traditional topical antibacterial drugs, it has a lower drug resistance rate, and the regimen of only once-daily administration also significantly improves patients' medication compliance.

The global market size related to ozenoxacin was approximately USD 270 million in 2023, and it is expected to expand steadily at a compound annual growth rate of 4.2% from 2024 to 2030. The growth momentum mainly comes from the release of primary dermatology diagnosis and treatment demand and the expansion of medication options for children's skin infections. At present, the original research products still occupy a dominant position in the market, and many domestic pharmaceutical companies have started generic drug declarations. With the advancement of the centralized procurement policy related to topical antibacterial drugs, the clinical accessibility of this variety is expected to be further improved.

The original research enterprise of ozenoxacin is the Italian Menarini Group, and the original trade name is Altabax. Its core compound patent expires in the United States in 2026, and the core compound patent in China expired in 2023. The main dosage form of the original research product is 1% topical ointment, with specifications of 15g/branch and 30g/branch. It has been included in the FDA Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Preparations for Chemical Drugs (8th Batch)*. Up to now, 3 enterprises in China have obtained CDE registration numbers for ozenloxacin API, all with the status of "A", and 5 domestic enterprises have obtained marketing approval for ozenoxacin ointment. (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 ozenoxacin API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the use needs of pharmaceutical companies in different scenarios such as R&D, quality research, and consistency evaluation.