Doxazosin

Benign prostatic hyperplasia (BPH) and hypertension are chronic diseases with high incidence among the middle-aged and elderly population. α1-adrenoceptor blockers are one of the core drugs for clinical treatment of these two types of diseases, and doxazosin is a representative long-acting variety in this category. It selectively blocks postsynaptic α1 receptors, relaxes the smooth muscles of the prostate and bladder neck, and rapidly relieves lower urinary tract symptoms such as dysuria and frequent urination in BPH patients. At the same time, it can dilate peripheral blood vessels and reduce peripheral vascular resistance to achieve a stable antihypertensive effect, especially suitable for BPH patients with concomitant hypertension, and the clinical medication demand is long-term stable.

The global market size of doxazosin has remained at around USD 1.2 billion in recent years, and the terminal sales of public medical institutions in China have maintained a steady growth rate of around 4% for three consecutive years, with the market size exceeding RMB 900 million in 2023. In terms of the competitive landscape, the original research product accounts for about 32% of the market share, and domestic generic preparations have become the mainstream of the market by virtue of higher cost performance. At present, doxazosin preparations of more than 20 enterprises have passed the consistency evaluation, among which both conventional tablets and sustained-release tablets have been included in the national centralized volume-based procurement, and the price reduction of the selected products has exceeded 80%, further driving the continuous expansion of the market demand for upstream API.

The original research enterprise of doxazosin is Pfizer, and the original research trade name is "Cardura". Its core compound patent expired in 2004, and the sustained-release formulation patent in China also expired in 2015. At present, the dosage forms approved by the original research in China include conventional tablets and sustained-release tablets, with specifications covering 1mg, 2mg and 4mg. They have been included in the *Catalogue of Chemical Reference Preparations* of China and also included in the FDA Reference Preparations Catalogue. Up to now, there are 18 doxazosin API registration records on the API registration platform of China CDE, among which 11 have been publicized in A status and can be legally supplied to preparation manufacturers for use, and 23 domestic enterprises have been approved to produce doxazosin related preparations. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for doxazosin API, which fully meet the regulatory requirements of multiple countries such as the Chinese Pharmacopoeia and FDA. Most products are available from stock, and stock orders placed before 16:00 can be shipped on the same day. It can fully meet the full-process needs of pharmaceutical enterprises in impurity research, quality control and registration declaration, and provide stable and reliable support for product R&D and compliance marketing.