Edaravone

In the clinical treatment of nerve injury diseases such as acute ischemic stroke and amyotrophic lateral sclerosis, oxidative stress injury excessively mediated by free radicals is one of the core pathological mechanisms. As the first free radical scavenger approved for neuroprotection, edaravone belongs to cerebral protective drugs. It can reduce oxidative damage to nerve cells and delay the degeneration of nerve function by scavenging hydroxyl free radicals and inhibiting lipid peroxidation. In addition to being clinically used to improve neurological symptoms, activities of daily living and functional disorders caused by acute cerebral infarction, it is also approved for the treatment of patients with amyotrophic lateral sclerosis, providing an important option for delaying the course of disease for patients with ischemic cerebrovascular diseases and neurodegenerative diseases.

The global edaravone market size exceeded USD 1.2 billion in 2023, with a compound annual growth rate maintained at around 8%. The growth is mainly driven by the expansion of demand for the amyotrophic lateral sclerosis indication and the increase in penetration rate in emerging markets. China is the main consumer market of edaravone preparations, accounting for more than 45% of the global demand. At present, the domestic preparation market has formed a pattern of co-competition between original research drugs and generic drugs. In the local centralized procurement since 2022, the average price reduction of edaravone injection has exceeded 60%, which further promotes the improvement of clinical accessibility, the demand for upstream API has subsequently expanded, and the demand for supply chain stability of selected preparation enterprises has increased significantly.

The original research enterprise of edaravone is Japan's Mitsubishi Tanabe Pharma Corporation, with the trade names "Radicut" and "Radicava". Its core compound patent in Japan expired in 2019, the compound patent in China expired in 2022, and the indication patent in the United States was extended to 2031. The main dosage forms of the original research drug are injections, with specifications including 20ml:30mg and 100ml:30mg. Meanwhile, an oral suspension dosage form has been approved in the United States. This product has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also included in the FDA Reference Preparations Catalogue. Up to now, nearly 30 Chinese enterprises have obtained A status for their edaravone APIs through CDE registration, and the domestically approved edaravone preparations cover multiple dosage forms such as injection, concentrated solution for injection and oral suspension. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the R&D and quality control requirements of edaravone, 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 compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for pharmaceutical enterprises in generic drug consistency evaluation, impurity research and daily quality release.