Nepafenac

In the clinical selection of ophthalmic non-steroidal anti-inflammatory drugs, nepafenac achieves differentiated advantages in mechanism of action by virtue of its unique prodrug design. As an amide-class non-steroidal anti-inflammatory prodrug, it has no pharmacological activity by itself. After eye drop administration, it can rapidly penetrate the cornea, and is hydrolyzed by amidase in ocular tissues to be converted into the active metabolite amfenac tromethamine. It blocks the synthesis of prostaglandins by inhibiting the activity of cyclooxygenase (COX), thereby exerting anti-inflammatory and analgesic effects. Clinically, it is mainly used to treat inflammatory reactions and ocular pain after cataract extraction and intraocular lens implantation, and can also be used for the prevention and control of ocular inflammation-related diseases such as allergic conjunctivitis and cystoid macular edema. The applicable population covers ophthalmic surgery patients requiring perioperative anti-inflammatory treatment and patients with chronic ocular inflammation. Compared with traditional non-steroidal anti-inflammatory drugs, it has higher ocular bioavailability and lower risk of systemic adverse reactions.

The global nepafenac market size has maintained a steady growth trend in recent years. In 2023, the market size was approximately USD 480 million, with a compound annual growth rate of around 6%. Benefiting from the continuous increase in the volume of ophthalmic surgeries in the Chinese market, the sales of nepafenac at the terminal of public medical institutions exceeded RMB 300 million in 2023, with a year-on-year growth rate of over 12%. At present, the competitive landscape is still dominated by the original research product. More than 10 domestic pharmaceutical companies have submitted marketing applications for generic drugs, among which 3 companies have their preparation products passed the consistency evaluation. With the entry of generic manufacturers after the expiration of patent protection, the market accessibility is expected to be further improved.

The original research enterprise of nepafenac is Novartis Pharma, and the original research trade name is "Nevanac". The expiration date of its core compound patent in the United States is 2023, and the core compound patent in China expired in 2021. The main dosage form of the original research product on the market is ophthalmic suspension, with a specification of 0.1% (5ml:5mg). This dosage form has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. Up to now, 6 enterprises in China have had their nepafenac active pharmaceutical ingredients (APIs) obtain Class A status through CDE registration, and another 12 enterprises have their APIs in the registration and publicity stage; 3 domestic enterprises have had their nepafenac ophthalmic suspensions approved for marketing. (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of nepafenac impurity reference standards, with most products available from 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 the Chinese Pharmacopoeia and FDA, and can provide stable reference material support for pharmaceutical enterprises in API research and development, quality control, and generic drug consistency evaluation.