Benorilate

As a classic prodrug of antipyretic, analgesic and anti-inflammatory class, benorilate is absorbed through the gastrointestinal tract and then hydrolyzed by esterase into aspirin and paracetamol, which not only retains the analgesic, anti-inflammatory and antipyretic effects of the two, but also greatly reduces the risk of gastrointestinal irritation caused by the single use of non-steroidal anti-inflammatory drugs. It is clinically mainly used for fever caused by common cold or influenza, and can also relieve mild to moderate pain such as headache, arthralgia, migraine, toothache, myalgia, neuralgia and dysmenorrhea, especially suitable for elderly patients and people who cannot tolerate the gastrointestinal adverse reactions of aspirin and paracetamol.

The overall market size of benorilate tends to be stable, with an annual global sales of approximately USD 320 million, an annual domestic market demand stable at around 600 tons, and a compound annual growth rate maintained at 2.1%. The competitive landscape is dominated by generic drug production, with domestic enterprises accounting for more than 70% of the global production capacity supply, mainly concentrated in pharmaceutical and chemical industry clusters such as Jiangsu, Hubei and Shandong. The terminal preparation has an affordable price and is classified as an OTC Class B drug, which can be purchased by patients themselves, so centralized procurement has little impact on the overall market landscape.

The original research enterprise of benorilate is Roche, with the original research brand name Benorilate. The core compound patent expired globally in 1982, and there is no core patent under research at present. The main dosage forms marketed in China include tablets and granules, among which the common specifications of tablets are 0.2g and 0.5g, and the specification of granules is 0.4g per bag. The original research product has not entered the Chinese market, and there are a total of 7 product specifications of domestic generic drug preparations that have been included in the Reference Listed Drugs in the *Collection of Chemical Drug Catalog*. Up to now, the CDE API Registration Platform has included a total of 16 benorilate API registration entries, among which 11 are in status A and can be legally marketed and sold in China, corresponding to more than 30 approved preparation varieties. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of benorilate impurity reference standards, most of which are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products meet the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can meet the full-process R&D needs such as impurity qualitative and quantitative research, quality standard establishment, and generic drug consistency evaluation, effectively shortening the R&D cycle of pharmaceutical enterprises and reducing compliance risks.