Loteprednol

For the clinical treatment of ocular inflammatory diseases, there has long been a core demand for "balancing anti-inflammatory effects and hormonal adverse reactions". As a new type of glucocorticoid drug, loteprednol exerts anti-inflammatory and anti-allergic effects by highly selectively binding to glucocorticoid receptors. Due to the introduction of ester groups in its structure, it achieves rapid metabolism in the eye with extremely low systemic exposure. It is clinically mainly used to treat ocular inflammatory reactions such as blepharitis, bulbar conjunctivitis, uveitis and corneal injury, and can also be used for the prevention and relief of postoperative ocular inflammation. Its applicable population covers ophthalmic patients who need long-term anti-inflammatory treatment and have poor tolerance to traditional hormones, which greatly reduces the risk of elevated intraocular pressure and cataract caused by long-term use.

At present, the global market size of loteprednol is approximately USD 320 million, with a compound annual growth rate maintained at around 4.7%. The growth momentum mainly comes from the increasing prevalence of chronic ophthalmic diseases such as dry eye syndrome and allergic conjunctivitis, as well as the continuous growth in the volume of cataract and refractive surgeries. The domestic market size is approximately RMB 280 million. Currently, the market is still dominated by the original research product. With the advancement of the consistency evaluation of generic drugs in China, loteprednol etabonate suspension eye drops from 3 enterprises have passed the consistency evaluation of generic drugs. After the implementation of centralized procurement, the market share of generic drugs is expected to increase to more than 60% within 3 years, and the corresponding demand for APIs will be released rapidly.

The original research enterprise of loteprednol is Bausch & Lomb Incorporated in the United States, with the original brand name "Lotemax". Its US compound patent expired in 2019, and the core patent in China expired in 2021. The main dosage forms of the original research product are 0.2% and 0.5% ophthalmic suspensions, which have been included in the FDA Reference Listed Drug Catalogue, and also included in the *Catalogue of Reference Preparations for Chemical Drugs* of China. As of now, loteprednol APIs from 6 domestic enterprises have obtained CDE registration numbers, among which 3 are in "A" status and can be supplied for the production and use of marketed preparations. Domestic preparation varieties such as loteprednol etabonate suspension eye drops and loteprednol etabonate and tobramycin eye drops 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 loteprednol impurity reference standards. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable and reliable reference standard support for API and preparation enterprises in quality research, consistency evaluation and registration declaration.