Levobunolol

For glaucoma, the world's leading irreversible blinding eye disease, β-blockers are the cornerstone drugs for clinical intraocular pressure-lowering treatment. As a non-selective β-adrenergic receptor blocker, levobunolol reduces aqueous humor production by blocking β1 and β2 receptors, which can lower intraocular pressure by 20% to 30%. It has definite efficacy in primary open-angle glaucoma, and is also suitable for the auxiliary pressure lowering of ocular hypertension and some angle-closure glaucoma, especially for patients intolerant to other β-blockers. Its long-term use has stable intraocular pressure lowering effect without obvious tachyphylaxis, and it is a commonly used pressure lowering option in ophthalmic clinical practice.

The global glaucoma drug market size has exceeded USD 13 billion in 2024, among which β-blockers account for approximately 17%. With a lower incidence of cardiovascular adverse reactions, levobunolol has maintained a compound annual growth rate of 4.2% in the past three years, which is higher than the average growth rate of similar β-blockers. In the domestic market, the original research products still occupy the main share at present, and only 3 enterprises have obtained approval for generic drug preparations. With the gradual expansion of the centralized procurement scope of ophthalmic drugs in recent years, the generic drug substitution space of this variety continues to release, and the demand for API also shows a steady upward trend accordingly.

The original research enterprise of levobunolol is the German company眼力健, with the original brand name "Betagen". Its core compound patent expired globally in 2008. The original dosage form is eye drops, with the common specification of 5ml:25mg. The original preparation has been included in the *Catalogue of Chemical Reference Preparations* of China, and is also listed in the FDA Reference Preparations Catalogue. At present, there is no approved A-status registration number for levobunolol on the domestic API registration platform, and only 2 enterprises have submitted registration applications which are under review. The preparations approved for marketing in China include the original product and 2 domestic generic drugs. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for levobunolol API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully support enterprises' needs in the whole process of API R&D, quality research and registration.