Modafinil

As an innovative variety of wakefulness-regulating drugs, modafinil selectively acts on the hypothalamic orexin neurons of the central nervous system to promote the release of wakefulness-promoting neurotransmitters, while avoiding the common side effects of traditional central nervous system stimulants such as overexcitation and high addiction potential. Clinically, it is mainly used to treat excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea-hypopnea syndrome, and can also be used to improve symptoms of idiopathic hypersomnia. The applicable population covers adult patients troubled by chronic sleepiness who need to maintain daytime wakefulness. Due to its high safety and good tolerability, it has become the first-line drug for the treatment of sleepiness disorders worldwide.

The global modafinil market size has maintained steady growth for a long time. In 2023, the market size was approximately USD 480 million, with a compound annual growth rate maintained at around 3.2%. With the improvement of the clinical diagnosis rate of sleepiness disorders and the expansion of indications such as shift work sleep disorder, the market demand still has room for continuous growth. In terms of the competitive landscape, after the patent expiration, generic drugs have rapidly occupied the market. Currently, generic drugs account for more than 75% of the global market share, and India and China are the main suppliers of active pharmaceutical ingredients (APIs). The modafinil APIs produced by domestic enterprises have occupied nearly 40% of the global supply of generic drug APIs due to their cost advantages and stable quality.

The original developer of modafinil is Cephalon Inc., and the original brand name is Provigil. The core compound patent in the United States expired in 2011, and all relevant patents in China have also expired. The main dosage form of the original drug is tablets, with two specifications of 100mg and 200mg, which have been included in the FDA Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Preparations for Chemical Drugs*. At present, the modafinil APIs of a number of domestic enterprises have completed registration with the Center for Drug Evaluation (CDE) and obtained A-status registration numbers, and domestic modafinil tablets have also been approved for marketing. (Data as of September 2024, please refer to the official website of CDE for the latest information.)

CATO provides a full set of modafinil impurity reference standards, most of which are available in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products can meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and provide stable reference standard support for API research and development, quality research and consistency evaluation.