Lisdexamfetamine

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder with a high incidence among children and adolescent groups globally. Without standardized intervention, it will severely affect the cognitive development and social functions of patients. Lisdexamfetamine is an active pharmaceutical ingredient (API) of central nervous system stimulant category. As a prodrug, it is converted into dextroamphetamine through enzymatic hydrolysis in vivo. It promotes the release of dopamine and norepinephrine in the synaptic cleft and inhibits their reuptake to regulate neurotransmitter levels, thereby improving the symptoms of inattention, hyperactivity and impulsivity in ADHD patients. Some of its indications also include adjuvant treatment of binge-eating disorder in adults, and it is one of the mainstream drugs for long-term clinical management of ADHD at present.

The global market size of lisdexamfetamine-related preparations had exceeded USD 2.8 billion in 2023. In recent years, with the increase in the diagnosis rate of adult ADHD, the market maintains a compound annual growth rate of around 6%. In terms of competitive landscape, the original research product still occupies the major market share in the world, with the United States and Europe as the core consumption regions. No generic preparation of this variety has been approved in China yet, which is still in the early stage of market introduction, and the potential clinical demand has not been met.

The original research enterprise of this variety is Celgene Corporation of the United States, and the original research trade name is Vyvanse. The core compound patent expires in 2023 in the United States, and the indication extension patent expires in 2029. At present, the main dosage form approved by the original research is oral capsule, with specifications including multiple levels of 20mg, 30mg, 40mg, 50mg and 70mg, which has been included in the FDA Reference Listed Drug Catalog. As of the retrieval time point, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China has not publicized the registration information of domestic or imported lisdexamfetamine APIs, and no preparation of this variety has been approved for marketing in China for the time being. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of lisdexamfetamine impurity reference standards, which can cover the impurity research needs of this variety throughout the process from API R&D to preparation declaration. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable reference standard support for the R&D and registration work of relevant enterprises.