Roxatidine

Acid-related diseases such as peptic ulcer and reflux esophagitis have long plagued more than 10% of the global population. Although traditional H2 receptor antagonists can inhibit gastric acid secretion, they generally have the problems of short duration of action and insufficient tolerance. As a third-generation selective H2 receptor antagonist, roxatidine competitively blocks histamine H2 receptors on gastric parietal cells, effectively inhibiting basal gastric acid, nocturnal gastric acid and gastric acid secretion caused by food stimulation. It has no anti-androgen effect, has minimal impact on liver drug enzymes, and has a lower risk of drug interactions. Clinically, it is mainly used for the treatment of gastric and duodenal ulcers, anastomotic ulcers, and reflux esophagitis, and can also be used as pre-anesthesia medication to prevent aspiration pneumonia. It is especially suitable for elderly patients and people with multiple underlying diseases who need long-term medication.

The current global market size of roxatidine-related preparations is approximately US$1.2 billion, with a compound annual growth rate of 4.2% in the past three years. The growth momentum mainly comes from the rising prevalence of acid-related diseases in the middle-aged and elderly population and the clinical replacement demand brought by its low adverse reactions. In terms of the domestic market, the overall size of roxatidine preparations has exceeded RMB 1.8 billion, of which oral preparations account for approximately 62% and injections account for 38%. At present, 12 domestic enterprises have obtained preparation approvals. After the centralized procurement, the price of generic preparations has dropped by more than 75%, the supply gap of upstream API has gradually widened, and the bargaining power of suppliers with compliance registration qualifications has continued to increase.

The original research enterprise of roxatidine is Astellas Pharma of Japan, with the original brand name "Altat". Its core compound patent expired globally in 2010, and the compound patent in China also expired in 2010. At present, the main dosage forms of the original research marketed products include 75mg roxatidine acetate hydrochloride sustained-release capsules and 100mg roxatidine acetate hydrochloride for injection, which have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, 8 enterprises have completed the A-status registration of roxatidine acetate hydrochloride API in CDE. A total of 17 roxatidine acetate hydrochloride preparation approvals have been approved for marketing in China, covering oral and injection dosage forms. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of roxatidine impurity reference standards. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API and preparation enterprises such as quality research, stability study, and registration declaration.