Latanoprost

Glaucoma is the world's leading irreversible blinding eye disease, and clinically, about 70% of patients with primary open-angle glaucoma take elevated intraocular pressure as the core pathogenic factor. Latanoprost is a prostaglandin analogue intraocular pressure lowering drug. By activating the FP prostaglandin receptor on the ciliary smooth muscle, it promotes the discharge of aqueous humor through the uveoscleral pathway, and can reduce intraocular pressure by 20%-40%. It is currently the first-line therapeutic drug for open-angle glaucoma and ocular hypertension recommended by clinical guidelines, especially suitable for patients who are intolerant to or have poor response to β-receptor blockers. It has good long-term medication safety, and its ocular irritation is significantly lower than that of traditional intraocular pressure lowering drugs.

At present, the global market size of anti-glaucoma drugs exceeds 14 billion US dollars, of which prostaglandin analogues account for nearly 50%. As a classic variety of this class of drugs, latanoprost maintains an annual market size of more than 1.2 billion US dollars. The annual sales of latanoprost preparations at the terminal of public medical institutions in China have exceeded 1.2 billion yuan, with a compound growth rate of 8.2% in the past 5 years. With the advancement of the consistency evaluation of generic drugs, the share of domestic preparations has increased from less than 20% in 2018 to 47% in 2023. The market competition between original research and generic enterprises has gradually entered a stalemate, and the demand for upstream API supply continues to rise with the expansion of preparation production capacity.

The original research enterprise of latanoprost is Pfizer, and the original research trade name is Xalatan. Its US compound patent expired in 2011, and the core compound patent in China expired in 2013. The original marketed dosage form is eye drops, with the mainstream specification of 2.5ml:125μg. This product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. At present, the latanoprost APIs of 12 domestic enterprises have been registered with the CDE with the status of A, and more than 30 latanoprost-related preparation varieties have been approved for marketing, covering dosage forms such as eye drops and ophthalmic gels. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for latanoprost, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the impurity benchmarking needs of pharmaceutical enterprises in the process of API R&D, quality research and production, and provide stable and reliable support for the consistency evaluation and compliance declaration of related preparations.