Entacapone

As a common degenerative disease of the central nervous system, Parkinson's disease is prone to motor complications such as "wearing-off phenomenon" and "on-off phenomenon" in patients after long-term treatment with levodopa, leading to urgent clinical treatment needs. Entacapone is a catechol-O-methyltransferase (COMT) inhibitor. By reversibly inhibiting the activity of peripheral COMT, it reduces the metabolic degradation of levodopa and prolongs the half-life and duration of action of levodopa. It is often used in combination with levodopa/benserazide and levodopa/carbidopa to improve the motor fluctuation symptoms of patients with Parkinson's disease, and is a core adjuvant drug in the combination treatment regimen for middle- and late-stage Parkinson's disease.

The global entacapone market size has been stably maintained at more than USD 1.2 billion, and the growth rate of the domestic market has been maintained at around 8% in recent years. The domestic market currently presents a pattern of coexistence of original research drugs and generic drugs. Entacapone generic drugs from more than 20 enterprises have been approved for marketing, and this variety has been included in the 7th batch of nationally organized drug centralized procurement. The price drop of the selected products exceeds 80%, which significantly improves clinical accessibility and also drives the continuous expansion of the market demand for upstream active pharmaceutical ingredients.

The original research enterprise of entacapone is Orion Corporation of Finland, and the original trade name is Comtan. The expiration time of its core compound patent in Europe and the United States is 2013 and 2014 respectively, and the expiration time of the compound patent in China is 2014. The original dosage form is film-coated tablet with a specification of 200mg, which has been included in the reference preparation list of the China Listed Drug Catalogue and also included in the FDA reference preparation catalogue. Up to now, there are more than 30 pieces of entacapone API registration information on the CDE API registration platform, among which nearly 20 are in the status of "A" (approved for use in marketed preparations). Many domestic enterprises have obtained marketing approval for preparations such as entacapone tablets and entacapone and levodopa and carbidopa tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

As a professional supplier deeply engaged in the field of pharmaceutical reference standards, CATO can provide a full set of impurity reference standards for entacapone API. Most of the products are in stock, and spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of the whole process including drug research and development, quality research, production quality control, etc.