卡巴拉汀

Alzheimer's disease is a neurodegenerative disease with high incidence in the elderly population, and cognitive decline caused by cholinergic neuron degeneration is one of its core pathological manifestations. Rivastigmine is a second-generation long-acting carbamate cholinesterase inhibitor, which can simultaneously and selectively inhibit acetylcholinesterase and butyrylcholinesterase in the brain, delay the degradation of cholinergic neurotransmitters, and enhance cholinergic nerve function. It is mostly used clinically to improve cognitive symptoms in patients with mild to moderate Alzheimer's disease, and can also be used in patients with mild to moderate dementia associated with Parkinson's disease, making it one of the basic medications in the field of senile cognitive impairment.

The current global market size of rivastigmine is approximately USD 1.2 billion, with a compound annual growth rate maintained at around 3.2%. The growth momentum mainly comes from the continuous rise in the prevalence of Alzheimer's disease amid the global aging process. In terms of the domestic market, the sales volume of rivastigmine at public medical institution terminals has exceeded RMB 900 million. With the gradual improvement of the coverage of dementia medications in the National Medical Insurance Catalogue, the growth rate is expected to reach 4.5% in the next three years. In the competitive landscape, the original research product still accounts for nearly 60% of the market share. Generic drugs from 3 domestic enterprises have passed the consistency evaluation, and the average price reduction of this variety in the provincial centralized procurement in 2021 reached 62%, further promoting the improvement of clinical accessibility.

The original research enterprise of rivastigmine is Novartis, with the trade name "Exelon". The core compound patent expired in 2012 in Europe and 2013 in the United States respectively, and the Chinese compound patent expired in 2009. The currently marketed original research dosage forms include capsules (1.5mg, 3mg, 4.5mg, 6mg) and transdermal patches (4.6mg/24h, 9.5mg/24h, 13.3mg/24h). Both dosage forms have been included in the China Listed Medicines Catalogue and are officially recognized reference preparations. In terms of domestic API registration, rivastigmine APIs from 6 enterprises have passed the review of the Center for Drug Evaluation (CDE) and obtained A-status registration numbers, and multiple domestic varieties of oral preparations and transdermal patches have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the R&D and production quality control needs of rivastigmine, CATO can provide a full set of impurity reference standards for this API. Most products are available from stock, and stock products ordered before 16:00 can 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 fully meet the needs of multiple scenarios such as impurity research, quality standard establishment, and release testing.