Oxolinic Acid

Urinary tract infection is a clinically common bacterial infectious disease, and quinolones are one of the mainstream treatment options for this type of disease. As a representative of the first-generation quinolone antibacterial drugs, oxolinic acid exerts a bactericidal effect by inhibiting the activity of bacterial DNA gyrase and blocking the process of bacterial DNA replication. It is mainly used for the treatment of urinary tract infections and intestinal infections caused by Gram-negative bacteria, and the applicable population is adult patients with no history of quinolone allergy. It is an important variety in the early antibacterial treatment system that fills the medication gap for infections caused by sensitive bacteria such as Streptococcus and Proteus.

At present, oxolinic acid has been gradually replaced by subsequent iterative quinolone varieties. The global market size has shrunk to less than 20 million US dollars, with an annual growth rate of less than 1%, and it is generally in the decline stage of the product life cycle. The market supply is dominated by generic pharmaceutical companies. Due to the limited clinical usage, no domestic enterprise has included it in the centralized procurement declaration catalog for the time being. Only some manufacturers focusing on characteristic antibacterial APIs maintain small-scale mass production to meet the niche clinical needs and the veterinary medication market.

The original research enterprise of oxolinic acid is Warner-Lambert Company of the United States, and the original research trade name is NegGram. The core compound patent expired globally in 1982. The main dosage form approved by the original research is tablet, with specifications including 0.25g and 0.5g, which has been included in the FDA reference preparation catalog. Up to now, no valid and listed registration number of oxolinic acid API has been found on the platform of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, and no preparation of this variety has been approved for marketing in China. (Data as of October 2025, please refer to the official CDE website for the latest information)

In response to the needs of oxolinic acid quality research and compliance declaration, CATO can provide a full set of impurity reference standards for this API. Most products 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, which can effectively shorten the R&D cycle and reduce the research cost.