About the shortage of methylphenidate hydrochloride products

Summary

• Concerta and Teva-XR modified-release tablets are expected to be in shortage until the end of December 2025
• Ritalin LA and Rubifen LA capsules are expected to be in shortage at various intervals until the end of December 2025 (see table below for dates for individual brands and strengths)
• Rubifen LA 40 mg capsules are in shortage

Pharmaceutical companies Janssen-Cilag and Teva Pharma have notified us about the shortages of their methylphenidate hydrochloride modified-release tablet products Concerta and Teva-XR (see table below). 

Novartis and AFT Pharmaceuticals have also notified us about current and anticipated shortages of their methylphenidate modified-release capsule products Ritalin LA and Rubifen LA (see table below). 

The shortages of Concerta and Ritalin LA products are due to manufacturing issues and are affecting multiple countries. The shortage of Teva-XR and Rubifen LA products has occurred due to an increase in demand caused by the unavailability of other methylphenidate products.

We are working with the pharmaceutical companies to minimise the impact on patients, prescribers and pharmacies by closely monitoring the supply of all products and updating this page with new information as soon as it becomes available. 

These methylphenidate hydrochloride products are used to treat attention deficit hyperactivity disorder (ADHD). 

We acknowledge the concerns and difficulties caused by shortages of these medicines, especially due to the specific requirements for prescribing and dispensing them. 

Other medicines approved to treat ADHD are available. 

We urge patients who will be affected by these shortages to speak with their pharmacist about supply. They should also consult with their prescribers early about their treatment plan, as new prescriptions may be needed to access alternate treatments. 

We have approved the supply of overseas-registered Concerta tablets under section 19A of the Therapeutic Goods Act 1989 to reduce the impact of these shortages. Go to the Section 19A approvals database for up-to-date information about these alternative products (search by the active ingredient ‘methylphenidate’).

You can go to the Medicine Shortage Reports Database- external site (search for ‘methylphenidate’) for the most up-to-date information. 

Information for patients

We understand how crucial it is for patients and their caregivers to have consistent access to their methylphenidate medicine.  

Your pharmacist can tell you about the best way to get your medicine during these shortages. To help with supply, we have approved access to several overseas-registered strengths of Concerta modified-release tablets. Your pharmacist can order these alternative products by contacting the approval holder, Medsurge. Further information is available on the Section 19A approvals database.

We understand it can be frustrating when you are unable to get your preferred brand of a medicine, but using other brands, including overseas-registered products, may at times be unavoidable during these shortages. 

If your pharmacist offers you an overseas-registered alternative medicine, they should explain any differences between the products.

Please note that certain medicines a pharmacist can substitute may cost you more, and in some cases you may require a new prescription. The pharmacist will tell you about this.

If you are having difficulty getting your regular medicines, speak to your doctor about alternative options for your situation. 

Information for pharmacists

We have approved the supply of multiple strengths of overseas-registered Concerta methylphenidate modified-release products. You can order these alternative products and supply them to patients using existing prescriptions for Concerta. 

You can call the approval holder, Medsurge Healthcare, on 1300 788 261 for details about ordering these products. Go to our Section 19A approvals database for more information.

Overseas-registered section 19A Concerta tablets are not PBS-subsidised. Please advise patients to contact their doctor if their prescribed medicine is unavailable and substitutable alternatives are either inappropriate or unavailable.

Information for prescribers

Your patients may want to discuss ongoing treatment options while methylphenidate products are unavailable.

Pharmacists, patients and carers may contact you to authorise use of alternative strengths or formulations of methylphenidate substitute medicines. We acknowledge the difficulties involved in the prescribing of controlled medicines and the extra administrative workload these shortages cause. We understand that knowing about shortages early enables you to review and change prescriptions and treatment for patients if needed. 

You can check this webpage and the Medicine Shortage Reports Database for the most up-to-date information. 

We have approved access to several strengths of overseas-registered Concerta methylphenidate modified-release tablets. Pharmacists can order these alternative products and supply them using existing prescriptions for Concerta. Further details are available on our Section 19A approvals database. 

Please also note that:

• section 19A-approved Concerta medicines are not PBS-subsidised and your patient may prefer a new prescription for a medicine that is subsidised on the PBS
• pharmacists will advise patients to contact you if their prescribed medicine is unavailable and substitutable alternatives are either inappropriate or unavailable.

General information

Please note that the dates given for these shortages may change and we encourage you to check the Medicine Shortage Reports Database for updates about the supply of methylphenidate products.

Also keep in mind that we can work with pharmaceutical companies to communicate information about medicine shortages to health professionals and patients, but we cannot compel companies to increase supply or apply to have their products subsidised on the PBS.

While we can suggest approaches to manage the supply of medicines during shortages, we do not have the power to regulate the clinical decisions of health professionals.

We will continue to monitor the supply of methylphenidate-containing products and work with the suppliers and relevant health professionals to update this advice if needed.

Please also know that there is always someone to talk to about mental health and behavioural concerns. If you or someone close to you is experiencing an emergency, or is at immediate risk of harm, call triple zero (000). To talk to someone now, call Beyond Blue on 1300 22 4636 or Lifeline on 13 11 14. 

The HealthDirect website has a full list of mental health resources at www.healthdirect.gov.au/mental-health-resources.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to our monitoring of these products.

We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.