Biperiden

In response to the clinical treatment needs of Parkinson's disease and drug-induced extrapyramidal reactions, anticholinergic drugs are an important option for symptomatic intervention. Biperiden, as a central anticholinergic drug, can selectively block the cholinergic pathway in the central striatum, improve the imbalance between dopamine and acetylcholine, and effectively alleviate tremor and myotonia symptoms in patients with Parkinson's disease. Meanwhile, it can also be used for acute extrapyramidal reactions caused by antipsychotics and other drugs. The applicable population covers patients with primary Parkinson's disease and patients with dyskinesia during the treatment of psychotropic drugs. Its peripheral anticholinergic effect is weak, the incidence of adverse reactions is relatively lower, and the clinical tolerance is good.

At present, the global market size of biperiden is approximately USD 120 million. Driven by the逐年上升 prevalence of Parkinson's disease and the expansion of the clinical application scope of psychotropic drugs, the compound annual growth rate in the past three years has remained at around 3.8%. China's market accounts for about 12%. At present, the supply side is dominated by generic drugs, and the market share of the original research product is less than 20%. Three domestic enterprises have obtained preparation approvals, but the supply of API has not yet been fully localized, and there is a certain market gap.

The original research enterprise of biperiden is Dr. R. Pfleger Chemische Fabrik GmbH, and the original trade name is Akineton. The core compound patent of it expired around 1980 in major markets such as Europe and the United States. The originally marketed dosage forms include tablets and injections. The common specification of tablets is 2mg, and the specification of injection is 5mg/1ml. The original research product has been included in the FDA Orange Book Reference Preparation Catalog, but it has not yet been included in the domestic reference preparation catalog. As of the search time point, no valid registration number of biperiden has been found on the CDE API registration platform. All the preparations approved for marketing in China are generic drugs, and there is no import approval for the original research preparation. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for biperiden API, covering all known impurities in the synthesis route and degradation process. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and the FDA. Most products are in stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard needs of pharmaceutical enterprises in R&D, quality research and production processes.