Methylphenidate shortage: Major ADHD drugs, Concerta, Teva to last until 2026

Two of three brands of medication used to treat ADHD will not be available to Australians until 2026 due to major shortages.

Methylphenidate hydrochloride, best known by brand name Ritalin, is used to kick the central nervous system into gear by boosting dopamine and noradrenaline levels in the brain.

The stimulant drug is a common treatment option for people with attention-deficit hyperactivity disorder.

In Australia, there are three approved brands for the long-acting drug: Concerta, Methylphenidate-Teva XR and Ritalin LA.

Concerta manufacturer Janssen-Cilag, part of pharmaceutical giant Johnson and Johnson, began anticipating shortages as early as October last year, citing manufacturing issues.

It came just weeks after the shortage of another long-acting drug, commonly known by brand name Vyvanse, had been resolved.

Last week, Janssen-Cilag advised the Therapeutic Goods Administration the shortage would last all year and affect all strengths — 18mg, 27mg, 36mg and 54mg.

Details of manufacturing issues and whether they’re related to Janssen-Cilag’s Belgium-based plant remain unclear, but the shortage is affecting multiple countries.

It led to Teva Pharma Australia reporting its own shortage because of an “unexpected increase in demand due to other sponsors unable to supply”, also affecting all four strengths and set to last all year.

The TGA has since approved the supply of the Swiss-registered version of Concerta in a bid to reduce the impact on patients.

A TGA spokesman said the regulator was closely monitoring the shortages, as well as supply of other medicines used to treat ADHD.

“Pharmaceutical companies do their best to maintain medicine supply through demand forecasting, stock control and backup supply routes. However, sometimes medicine shortages cannot be prevented,” he said.

An estimated one million Australians live with ADHD — about one in 20 — but only a select number of drugs are approved for treatment.

Diagnostic improvements over time have led to increased awareness and diagnosis of the neurodevelopmental condition.

The number of prescriptions for ADHD medication more than doubled in the five years between 2018 and 2022, from about 1.4m to roughly 3.2m, according to a Department of Health and Aged Care briefing note.

“Certainly, the demand for ADHD medications worldwide continues to increase steadily and so it may be as simple as the manufacturers not keeping pace with that steady increase — they do not have to of course — how much they produce is up to their commercial decision-making,” said Dr Roger Paterson, chair of ADHD WA’s professional advisory body.

“But it seems heartless to think that they know that they need to increase manufacturing to keep pace with demand, but choose not to do so.”

Timely access to medication was one of several barriers to care acknowledged in a recent Senate inquiry report on ADHD in Australia.

Australian Medical Association president Danielle McMullen said disruption to supply can be “frustrating and stressful” for people managing the condition.

“There are many factors that contribute to shortages. We’ve spoken to the TGA about these shortages and we will continue to work together to minimise impacts on patients regardless of any potential changes to ADHD diagnosis,” Dr McMullen said.

The TGA said while it cannot compel a business to register or manufacture medicine in Australia, it is “actively investigating and developing reforms to better anticipate, manage and communicate medicine shortages and discontinuations”.