The supply shortage of the ADHD drug Concerta OROS (Osmotic controlled-Release Oral delivery System) extended-release tablets (methylphenidate hydrochloride) has been going on for a long time with no clear solution in sight.
Its supplier Janssen Korea says the “timeline is uncertain due to supply and demand issues,” and the government hasn't taken any real action to address the shortage. In the meantime, healthcare providers are being forced to consider prescribing alternative medications, and patients are feeling anxious about having their familiar medication changed.
According to data submitted to the Ministry of Food and Drug Safety (MFDS) by Janssen Korea, which supplies the drug in Korea, all dosage forms of Concerta (18 mg, 27 mg, 36 mg, and 54 mg) will be in short supply sequentially throughout the first half of 2025. The 18mg product is expected to be in short supply starting March 3, and the 27mg product is in short supply starting April 7. The 36mg product has been in short supply since Jan. 13, and the 54mg product since Jan. 17.
Worse yet, this is not a one-off supply disruption but a continuous problem. The 18mg product had been out of stock once before Jan. 16, and the 27mg product experienced two shortages last year alone (in June and September).
Despite the recurring shortages, the supplier has not offered concrete measures to address the shortages.
“We deeply recognize the importance of a stable supply of Concerta, and we are committed to maintaining consistent supply and minimizing the impact of shortages,” Janssen Korea said in a statement. However, the company added, “Due to uncertain market conditions and increasing demand, it is difficult to predict when supply will normalize.”
According to the shortage report, the supplies of 36mg and 54mg products are scheduled to return to normal on March 28, 18mg on May 8, and 27mg on May 26. However, based on previous experience and responses, a delay cannot be ruled out.
Of course, the cause of the Concerta shortage can be viewed from different perspectives.
According to data obtained by Rep. Kim Yoon of the Democratic Party of Korea from the MFDS and the Health Insurance Review and Assessment Service (HIRA) last year, the number of prescriptions for ADHD (attention-deficit hyperactivity disorder) medications in 2023 increased 3.3 times over the previous four years, and the average prescription volume for unreimbursed patients was 1.4 times higher than that of reimbursed patients.
The surge can be attributed to changing social perceptions of ADHD, which has led to more normalized diagnosis and treatment. On the other hand, the pattern of unreimbursed prescription, which is concentrated in patients from their teens to 30s, especially teenagers, has led people to suggest that Concerta is being misused as a "study pill.”
The government has tightened methylphenidate prescribing criteria in 2022, but there is still no real solution to the shortage.
What’s needed now is responsible behavior from the government and the pharmaceutical company.
The supplier must do more than just announce a timeline for normalization. It must stick to the promised schedule and remain transparent about the reasons and alternatives for any delays. The government must take practical steps to protect ADHD patients by securing alternative treatments and diversifying the supply chain.
For people with ADHD, access to medication is critical to maintaining quality of life. Long-term solutions are needed to ensure patients do not experience treatment gaps due to simple supply and demand issues.