The Spanish Agency for Medicines and Health Products (Aemps) announced Thursday that the supply of long-acting methylphenidate drugs, used to treat Attention Deficit Hyperactivity Disorder (ADHD), will return to normal in early 2025, following problems since April of this year.
The recovery will be possible because laboratories such as Liconsa, manufacturer of Atenza, and Janssen-Cilag, responsible for Concerta, have significantly increased their production. In particular, Liconsa has increased its supply by 721% in recent months and will double production at its Guadalajara plant during 2025.
Shortage impact and mitigation measures
Since April, the availability of these drugs has been affected due to the global increase in demand and limited production capacity, as reported by the Aemps. Janssen-Cilag, which holds more than 80% of the market, reduced marketing in Spain by 12.6% during 2024, which generated a knock-on effect in other companies such as Rubió, Sandoz and Viatris, which also experienced difficulties with the active ingredient and packaging materials. To mitigate the impact on patients, the Aemps made 18 mg foreign drugs available to the autonomous communities, which can still be obtained at authorized dispensing points. In addition, in collaboration with scientific societies such as the AEPNyA, the AEP and the SEPSM, recommendations were issued for healthcare professionals to evaluate temporary changes in treatments, such as the substitution of extended-release drugs for immediate or modified alternatives.
The distribution challenge
Although the production increase has been announced, the Aemps warns that distribution of the drugs to pharmacies may take weeks due to the time needed to fill the supply chain. “It is normal for punctual tensions to persist in some areas while the pharmaceutical distribution channel is reestablished,” explained the agency, which also stressed its commitment to guaranteeing access to treatments for patients.
