What is the status of dexmethylphenidate (Azstarys) on the market?

Dexmethylphenidate (Azstarys) was jointly developed by the American pharmaceutical company KemPharm and Corium. It was officially approved for marketing by the U.S. Food and Drug Administration (FDA) on March 2, 2021, for the long-term management of ADHD in children and adults aged 6 years and above. This approval marks another step forward in the research and development of stimulant drugs, and also reflects an important breakthrough in the pharmaceutical industry in "the coexistence of long-acting treatment and low risk of abuse."

Dexmethylphenidate received widespread attention in the early stages of its launch, mainly due to its unique drug delivery system and dual active ingredient design. Compared with traditional methylphenidate preparations (such as Concerta and Ritalin), it uses serdexmethylphenidate, an innovative prodrug, for the first time, which is slowly converted into active dexmethylphenidate in the body, effectively controlling the drug release rate and extending the duration of the drug effect to more than 13 hours. The American Psychiatric Association and several ADHD research institutions believe that this mechanism can help reduce the risk of abuse and dosage fluctuations, especially for adolescent patients who need to concentrate throughout the day.

Currently, dexmethylphenidate is widely available in the U.S. market, but it has not yet entered the drug registration catalog in mainland China, so it cannot be purchased in domestic pharmacies or hospitals. According to public information from the China Food and Drug Administration (NMPA), the drug has not yet submitted a marketing application, and has not been included in the National Medical Insurance Drug List.

In terms of overseas drug prices, dexmethylphenidate is a prescription drug and is relatively expensive. Generally, each bottle of 100 pills sells for about US$350 to US$400, depending on the dosage specification. Partial reimbursement is available under some U.S. insurance plans. After the drug was launched, it was welcomed by doctors and parents, and its market share continued to increase among long-acting ADHD treatment drugs. Since 2024, many school districts and pediatric institutions in the United States have included dexmethylphenidate on the list of recommended drugs.

Reference materials:https://azstarys.com/