Atomoxetine

In the clinical treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents, non-central stimulant drugs have been a research hotspot in recent years. Atomoxetine Hydrochloride is a highly selective norepinephrine reuptake inhibitor. By specifically blocking the norepinephrine transporter on the presynaptic membrane, it increases the concentration of norepinephrine in the synaptic cleft, thereby improving the core symptoms of ADHD patients such as inattention, hyperactivity and impulsivity. Meanwhile, it can reduce the addiction risk of central stimulant drugs. It is currently the only non-stimulant drug approved for the long-term treatment of ADHD in children aged 6 years and above, adolescents and adults, and is especially suitable for patient groups who are intolerant to stimulant treatment or have a risk of substance abuse.

At present, the global prevalence of ADHD shows a continuous upward trend, driving the steady expansion of the market size of Atomoxetine Hydrochloride. In the past two years, the global market size has exceeded 1.2 billion US dollars, with a compound annual growth rate maintained at around 7%. The growth in the Chinese market is even more significant. The compound annual growth rate of terminal sales in public medical institutions exceeds 15%, and the sales volume in 2023 is close to 800 million yuan. In terms of the competitive landscape, the original research product still accounts for nearly 40% of the market share. More than 20 domestic enterprises have obtained approval for the marketing of their generic preparations, and this variety has been included in the seventh batch of nationally organized drug centralized procurement, with the price of winning bids reduced by more than 70%. The demand for cost-effective and compliant API from downstream preparation enterprises continues to be released.

The original research enterprise of Atomoxetine Hydrochloride is Eli Lilly and Company, with the original brand name Strattera. Its core US compound patent expired in 2017, and its Chinese compound patent expired in 2021. The main dosage forms approved by the original research are capsules, with specifications including 10mg, 18mg, 25mg, 40mg, 60mg, etc., which have been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and the FDA Reference Preparation Catalogue. Up to now, there are more than 30 registration entries of Atomoxetine Hydrochloride API on the API registration platform of China CDE, among which more than 15 have obtained the A status. Many domestic enterprises have obtained approval for the marketing of preparations such as Atomoxetine Hydrochloride capsules and oral solutions. (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 Atomoxetine Hydrochloride, covering process impurities, degradation impurities and isotope-labeled substances, which can fully meet the needs of the whole process of process R&D, quality research and registration declaration. Most products are in stock, and spot orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can be provided with complete structure confirmation and traceability data, helping enterprises efficiently complete quality compliance work.