Phenoxybenzamine

In the clinical diagnosis and treatment of peripheral vasospastic diseases and pheochromocytoma-related hypertension, α-adrenergic receptor blockers have always been the core category of medications. As a representative long-acting non-selective α-receptor blocker, phenoxybenzamine can form irreversible binding with α-receptors, continuously inhibit the vasoconstrictive effect of catecholamines, dilate peripheral blood vessels and reduce peripheral resistance. In addition to being clinically used for peripheral vasospastic diseases such as Raynaud's syndrome and thromboangiitis obliterans, it can also be used for preoperative preparation of pheochromocytoma and improvement of urinary retention symptoms caused by benign prostatic hyperplasia, and the applicable population covers adult patients who need long-term control of vasospasm symptoms and perioperative patients with pheochromocytoma.

The current global market size of phenoxybenzamine preparations is approximately USD 230 million, with a compound annual growth rate maintained at around 3.2%. The growth momentum mainly comes from the expansion of demand for symptomatic treatment of benign prostatic hyperplasia in urology. In terms of the domestic market, the currently approved phenoxybenzamine preparations are mainly generic drugs, with a total of 12 preparation approvals. The sales volume at medical institutions exceeded RMB 120 million in 2022, and there is no record of this variety being included in the national centralized volume-based procurement.

The original research enterprise of phenoxybenzamine is Reliant Pharmaceuticals, and the original trade name is Dibenzyline. The core compound patent in the United States expired in 1983. The main dosage form of the original drug is 10mg oral tablet, which has been included in the FDA Orange Book Reference Listed Drug Catalog. In terms of the domestic market, there are currently 6 A-status registration numbers for phenoxybenzamine API, all of which are produced by domestic enterprises, and no original research API has been declared and registered in China; the domestically approved phenoxybenzamine preparations include two dosage forms of tablets and injections, both of which are domestic generic drugs. (Data as of July 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for phenoxybenzamine API. Most of the products are in stock. In-stock products ordered before 16:00 will be shipped on the same day. They can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and provide stable reference material support for pharmaceutical enterprises' API R&D, quality research and consistency evaluation work.