Brinzolamide

Glaucoma is the leading irreversible blinding eye disease worldwide, and high intraocular pressure is the core risk factor for its progression. Traditional systemic administration of carbonic anhydrase inhibitors is prone to cause adverse reactions such as electrolyte disturbance, so there is an urgent clinical need for safer options for local intraocular pressure reduction. Brinzolamide is a selective carbonic anhydrase Ⅱ inhibitor with high affinity. It reduces aqueous humor production by inhibiting the activity of carbonic anhydrase in the ciliary body, and can effectively lower the intraocular pressure of patients with open-angle glaucoma and ocular hypertension. It can be used as a monotherapy regimen for patients intolerant to β-receptor blockers, and can also be used in combination with other intraocular pressure lowering drugs to improve the pressure control effect. The applicable population covers adult and adolescent patients. With the advantage of low incidence of local ocular adverse reactions, it has become an important drug option in the stepwise treatment of glaucoma.

The continuous increase in the number of glaucoma patients worldwide has driven the steady expansion of the market for brinzolamide-related preparations. In 2023, the global market size was approximately USD 1.28 billion, with a compound annual growth rate of 4.2% in the past five years. The growth rate of the Chinese market is higher than the global average. In 2023, the terminal sales in public medical institutions were approximately RMB 870 million, with a compound annual growth rate of 7.1% in the past three years. At present, the domestic preparation market is co-occupied by original research drugs and generic drugs. Since 2020, brinzolamide eye drops from 6 domestic enterprises have been approved for marketing. After the implementation of centralized procurement, the market share of generic drugs has gradually increased, driving the continuous rise in demand for upstream API. There is no publicly verifiable data on the segmented share of the global competitive landscape.

The original research enterprise of brinzolamide is Novartis, and the original trade name is Azopt®. The core compound patents expired in 2015 and 2017 in the United States and China respectively. The main dosage form approved for the original research drug is eye drops, with the conventional specification of 5ml:50mg, which has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA reference preparation catalogue. In terms of domestic API registration, as of the retrieval time point, more than 10 enterprises have obtained A-status registration numbers for brinzolamide API, and a number of domestic brinzolamide eye drops have been approved for marketing, which can fully meet the domestic preparation production demand. (Data as of July 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of brinzolamide 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. They meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully support the full-process research needs such as API R&D, quality research and preparation consistency evaluation.