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)
• Substitute overseas-registered methylphenidate modified-release capsules in multiple strengths have been approved
• We have convened a Medicine Shortage Action Group   

Pharmaceutical companies (the sponsors) 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.

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. 

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

The TGA’s response to these shortages

Our role in medicine shortages is to reduce the impact on patients where possible. For the methylphenidate modified-release product shortages, we: 

• have approved the supply of multiple strengths of overseas-registered methylphenidate modified-release products under section 19A of the Therapeutic Goods Act 1989 (go to the Section 19A approvals database for up-to-date information about these alternative products; search by the active ingredient ‘methylphenidate’).
• are working with wholesalers to distribute stock fairly when it is available
• are working with the sponsors 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 
• are meeting with medical colleges, health professional organisations and peak body groups to develop clinical management advice about alternatives during the shortage (see below)
• are communicating updates on this webpage and also the Medicine shortage reports database - external site. 

We have convened a Medicine Shortage Action Group (MSAG) with the following health professional groups and peak body groups for input to help us manage the shortage:

• ADHD Foundation
• Advanced Pharmacy Australia (AdPhA)
• Australian Medical Association (AMA)
• Australasian Society for Developmental Paediatrics (ASDP)
• Australasian ADHD Professionals Association (AADPA)
• National Aboriginal Community Controlled Health Organisation (NACCHO)
• Pharmaceutical Society of Australia (PSA)
• Royal Australian and New Zealand College of Psychiatrists (RANZCP)
• Royal Australian College of General Practitioners (RACGP)
• Royal Australasian College of Physicians (RACP)
• Pharmacy Guild of Australia.

Check this webpage for updates with information and guidance from the Methylphenidate Medicine Shortage Action Group. 

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 methylphenidate modified-release products in several strengths. Your pharmacist can order these alternative products by contacting an approval holder, whose details are 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 methylphenidate modified-release products. You can order these alternative products and supply them to patients using existing prescriptions. 

You can call the approval holders, Phero Pharma on (02) 9420 9199 or 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 methylphenidate modified-release products 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 - external site for the most up-to-date information. 

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

Please also note that:

• section 19A-approved methylphenidate modified-release products 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 - external site for updates about the supply of methylphenidate products.

While we can work with pharmaceutical companies to communicate information about medicine shortages to health professionals and patients, 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 - external site.

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.