Methyldopa

In response to the medication needs of the clinically special population with gestational hypertension, methyldopa, as a central α2 adrenoceptor agonist, is one of the few first-line antihypertensive drugs that have been proven safe for use during pregnancy. Its mechanism of action is to stimulate α2 receptors in the medullary motor center, inhibit the conduction of peripheral sympathetic nerve impulses, and reduce peripheral vascular resistance, while not significantly reducing renal blood flow and glomerular filtration rate. In addition to being used for the whole-course management of gestational hypertension, it is also suitable for hypertensive patients with combined renal insufficiency, and is a key basic drug for the treatment of clinically segmented hypertensive populations.

At present, the global market size of methyldopa is stable at around USD 120 million. Driven by the rising prevalence of hypertension among people of childbearing age and the improvement of maternal health care systems in developing countries, the compound annual growth rate has remained at 3.8% in the past three years. For the domestic market, this variety has been included in the National Essential Medicines List. In 2023, the terminal sales in public medical institutions exceeded RMB 210 million. The competitive landscape is dominated by generic drugs. At present, there are 7 domestic approved preparation manufacturers, and local enterprises account for more than 90% of the API supply end, so there is no exclusive monopoly market pattern yet.

The original research enterprise of methyldopa is Merck & Co., Inc., with the original brand name Aldomet. The core compound patent expired globally in 1980. At present, the mainstream marketed dosage forms include 250mg tablets and 500mg tablets, among which the 250mg specification of the original product has been included in the FDA Reference Listed Drug Catalog and the China Listed Drug Catalog. As of now, there are a total of 6 methyldopa A-status registration numbers on the API registration platform of China CDE, and 11 domestic manufacturers have obtained approval for the marketing of methyldopa tablets, which can meet the needs of routine clinical use. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of methyldopa impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for pharmaceutical enterprises in API quality research, preparation stability study and registration declaration.