Ritalin

Attention-deficit/hyperactivity disorder (ADHD), a neurodevelopmental disorder with high incidence in childhood and adolescence, has long lacked clinically intervention regimens with both safety and long-term efficacy. Methylphenidate is currently the first-line central nervous system stimulant for the treatment of ADHD. It blocks the reuptake of dopamine and norepinephrine to increase the concentrations of these two neurotransmitters in the synaptic cleft, thereby improving core symptoms such as inattention, hyperactivity and impulsivity. In addition to pediatric ADHD patients, it can also be used for the symptomatic treatment of adult ADHD and narcolepsy. It is the first drug worldwide approved by the FDA for ADHD treatment, with sufficient clinical evidence.

In recent years, the global market size of methylphenidate preparations has been stable at more than 3 billion US dollars, among which long-acting sustained-release formulations account for more than 65%, and the compound annual growth rate is maintained at around 4.2%. Driven by the increased diagnosis rate of ADHD and the popularization of awareness of adult indications in the domestic market, the growth rate in the past three years has reached 8.7%. Currently, the market is dominated by the original research product. Generic preparations from 3 domestic enterprises have passed the consistency evaluation, and another 7 enterprises are in the declaration stage. As the relevant indications are included in the outpatient reimbursement scope for chronic and special diseases, the demand in the primary market is expected to be further released.

The original research enterprise of methylphenidate is Johnson & Johnson of the United States, with the trade name Concerta. Its core compound patent expired in 2004, and the patent for the sustained-release formulation in China expired in 2023. The main dosage form of the original research product is methylphenidate hydrochloride sustained-release tablets, with three specifications of 18mg, 36mg and 54mg. It has been included in the *Catalogue of Chemical Reference Preparations* published by the NMPA, and is also collected in the FDA Reference Preparations Catalogue. At present, more than 20 methylphenidate-related active pharmaceutical ingredients (APIs) have obtained CDE registration numbers in China, among which 8 are in Status A, and 7 methylphenidate hydrochloride preparation varieties have obtained domestic marketing approval. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full range of methylphenidate impurity reference standards. Most products are in sufficient stock, and spot orders paid before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API R&D, quality research and consistency evaluation work.