Dorzolamide

Glaucoma is the leading irreversible blinding eye disease globally, among which high intraocular pressure is the core risk factor inducing optic nerve injury. Long-term intraocular pressure control for patients with open-angle glaucoma and ocular hypertension in clinical practice is the focus of clinical treatment. Dorzolamide is a carbonic anhydrase Ⅱ inhibitor, which reduces aqueous humor production and thus lowers intraocular pressure by selectively inhibiting the activity of intraocular carbonic anhydrase. It can be used alone for patients intolerant to β-blockers, and can also be combined with β-blocker eye drops to improve the hypotensive effect. Local administration can avoid adverse reactions such as electrolyte disorders caused by systemic carbonic anhydrase inhibitors, with higher clinical safety.At present, the global anti-glaucoma drug market size has a 5-year compound annual growth rate of approximately 4.2%, among which local carbonic anhydrase inhibitors account for about 8% of the overall market share, and the growth rate of dorzolamide as a segment in this category is higher than the average level. In terms of the domestic market, after the patent expiration of the original research product, the number of generic drug declaration enterprises has gradually increased. At present, 5 domestic enterprises have obtained the approval documents of dorzolamide-related preparations. The market size of grade-A hospitals covered by centralized procurement on the API supply side exceeds 200 million yuan. Moreover, with the increase in the prevalence of glaucoma, the market size is expected to maintain a growth rate of about 5% in the next 3 years.The original research enterprise of dorzolamide is Merck Sharp & Dohme, with the original research trade name Trusopt®, and the core compound patent expired in the United States in 2008. The main dosage form of the original research product is eye drops, with a specification of 2% (5ml:100mg). The original research product has been included in the Catalogue of Marketed Drugs in China and is the reference preparation for this product. At present, there are 6 approved approval numbers with the registration status of A for domestic dorzolamide APIs, and dorzolamide timolol eye drops from many enterprises corresponding to the preparations have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)CATO can provide a full set of dorzolamide impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and fully satisfy the reference standard requirements for the whole process of API R&D, quality research and quality control, helping enterprises to rapidly advance projects, reduce R&D risks and accelerate the declaration efficiency.

当前全球抗青光眼药物市场规模已超5年复合增长率约4.2%，其中局部碳酸酐酶抑制剂占整体市场份额的8%左右，多佐胺作为该细分品类增长速度高于平均水平。国内市场方面，原研产品专利到期后，仿制药申报企业数量逐步放量，目前国内已有5家企业获得多佐胺相关制剂批件，原料药供应端集采覆盖等级医院市场规模超2亿元，且随着青光眼患病率提升，预计未来3年市场规模将保持5%左右的增速。

多佐胺原研企业为默沙东，原研商品名为Trusopt®，核心化合物专利美国到期时间为2008年。原研主要剂型为滴眼液，规格为2%（5ml:100mg，原研产品已列入中国上市药品目录集，为该品参比制剂。目前国内多佐胺原料药已有6条登记状态为A的获批文号，对应制剂已有多家企业的多佐胺噻吗洛尔滴眼液获批上市。（数据截至2024年10月，最新请以CDE官网为准）

CATO/佳途科技可提供多佐胺全套杂质标准品，大部分产品现货供应，现货产品16:00前下单当天发货，全面符合中国药典、FDA等多法规合规要求，充分满足原料药研发、质量研究、质量控制全流程的对照品需求，助力企业快速推进项目，降低研发风险，加快申报效率。