Donepezil

Alzheimer's disease is the main cause of cognitive dysfunction in the elderly population. At present, there is still a lack of radical treatment in clinical practice, and the accessibility of symptomatic treatment drugs directly affects the quality of life of patients. Donepezil is a second-generation highly selective acetylcholinesterase inhibitor. It reversibly inhibits the hydrolysis of the neurotransmitter acetylcholine by acetylcholinesterase, improves the signal transduction efficiency of the central cholinergic pathway, and thus improves the cognitive, memory and daily activity abilities of patients with mild, moderate and severe Alzheimer's disease. It is a first-line basic drug for this disease recommended by global guidelines, and the applicable population covers patients in the whole course of the disease from early screening and diagnosis to late home care.

At present, the global market size of symptomatic drugs for Alzheimer's disease exceeds 7 billion US dollars. As the variety with the longest clinical application and the most sufficient evidence-based evidence, donepezil accounts for a stable share of about 12%. With the acceleration of the domestic aging process, the prevalence of Alzheimer's disease among people over 65 years old has reached 5.56%, corresponding to more than 10 million patients. The domestic market size of donepezil has exceeded 1.8 billion yuan, with an annual compound growth rate of 6.8%. After the expiration of the original research patent, the generic drug market has expanded rapidly. At present, nearly 30 domestic enterprises have obtained approval for the marketing of donepezil preparations, among which 17 have passed the consistency evaluation. The market share of generic drugs in public medical institutions has exceeded 90%. After centralized procurement, the cost of a single pill has dropped to 0.3 yuan, greatly reducing the medication burden of patients.

The original research enterprise of donepezil is Eisai Co., Ltd. of Japan, with the trade name Aricept. The expiration time of its core compound patent in the United States is 2010, and the Chinese compound patent expired in 2009. At present, the dosage forms of the original research drug approved globally include conventional tablets, orally disintegrating tablets and sustained-release tablets, covering three specifications of 5mg, 10mg and 23mg. All the above dosage forms have been included in the FDA Reference Listed Drug Catalog, among which the 5mg and 10mg conventional tablets have also been included in the Chinese *Catalog of Reference Listed Drugs for Chemical Drugs*. According to the domestic API registration platform, 24 enterprises have obtained A-status registration numbers for donepezil APIs. Both the original research and local enterprises' donepezil preparations have been approved for marketing in China, covering all conventional dosage forms. (Data as of November 2024, please refer to the official website of CDE for the latest information)

As a professional service provider deeply engaged in the field of pharmaceutical reference standards, CATO can provide a full set of donepezil impurity reference standards. Most products are in stock. Orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API R&D, quality research and registration declaration.