Midodrine

For patients with orthostatic hypotension, dizziness, blackout and even syncope when getting up daily are high-frequency risks that trouble their lives for a long time. As a selective α1 adrenoceptor agonist, midodrine is currently the core first-line drug for clinical management of such symptoms. It acts by agonizing α1 receptors on peripheral blood vessels, constricting small arteries and veins, increasing peripheral vascular resistance, thereby raising upright blood pressure and reducing insufficient cerebral blood supply caused by postural changes. It is mainly used for the treatment of primary orthostatic hypotension and orthostatic hypotension secondary to autonomic nerve dysfunction, and can also adjuvantly improve dialysis-related hypotension symptoms. The applicable population covers adult patients and some adolescent patients evaluated clinically.

The global midodrine market size has maintained steady growth in recent years. In 2023, the overall market size was approximately USD 320 million, with a compound annual growth rate maintained at around 4.7%. For the domestic market, with the acceleration of population aging and the gradual increase in the diagnosis rate of orthostatic hypotension, the domestic market size of midodrine preparations exceeded RMB 360 million in 2023, with an annual growth rate of 8.2%. The current market competition is dominated by generic drugs. More than 10 domestic enterprises have obtained approval for the production of midodrine tablets. After the implementation of centralized procurement, the price has dropped significantly, and the accessibility has been remarkably improved. The supply of APIs is mainly from domestic manufacturers, with the supply share of leading enterprises accounting for more than 60%.

The original research enterprise of midodrine is Nycomed Pharma, with the original brand name "Gutron". Its core compound patent expired globally in 2008. The original midodrine hydrochloride tablet is mainly in 2.5mg specification, which has been included in the FDA Reference Listed Drug Catalog, and is also included in China's *Catalog of Reference Preparations for Chemical Drugs (29th Batch)*. In terms of domestic API registration, 7 enterprises have obtained A status for their midodrine hydrochloride APIs after registration with CDE, which can be associated with preparation declaration for marketing approval. 9 domestic enterprises have obtained approval for marketing of midodrine hydrochloride tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the demands of midodrine generic drug R&D and quality control, CATO provides a full set of impurity reference standards for this API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They are compliant with multiple regulations including Chinese Pharmacopoeia and FDA, which can effectively help enterprises shorten the R&D cycle and reduce compliance risks in the quality research stage.