*This article has been updated on May 30, 2010.
Concerta is a long acting preparation of Methylphenidate. It was launched in the US in 2000, and in Canada in 2003.
When a new medication is released, the company which produces it has a patent for a certain number of years. This allows them to market the medication exclusively until the patent runs out. This is important for the company to recoup the money invested in research and development of the new medicine, as well as to earn a profit.
I understand that it is reasonably regular that the generic pharmaceutical companies petition the courts to create a generic version of the medication BEFORE the patent runs out. Companies that create generic medicines are able to take the formula of the medication, and produce it. They then sell it at a lower price than the original medication. Often times, the generic is at a price point that is only 20-30% better than the original medication.
For background on generic medication, I want to point you to these resources:
- An Article on generic medications in ADHD – Are They The Same?
- An Article on Adderall XR going generic in the US. Take note of the comments that people share – many of them explaining the side effects and difficulties with the generic version, as well as frustrations with their pharmacies and insurance – Generic Adderall XR in the US; and Generic Adderall XR – New Formulations
Concerta Going Generic In Canada:
Concerta was brought to market in Canada by Janssen Ortho. In mid January 2010, Novopharm won a lawsuit in Canada, to be able to start to produce a ‘concerta like’ medication in Canada. The courts essentially overthrew Janssen’s patent on Concerta. Novopharm is planning to market Novo-Methylphenidate ER C, as a replacement for patients taking Concerta.
N.B. In early summer 2010, the name of the generic medicine will change from: Novo-Methylphenidate ER-C to Teva-Methylphenidate ER-C. This article will be updated when the product’s name is fully changed over.
Let’s Review the Pros and Cons of Novo-Methylphenidate ER-C:
Cons of Generic Concerta:
1) Does this medication work equally to Concerta?
Unfortunately, no one knows the answer to that. For a generic company to get approval for a new medication, they simply have to prove that their medication is absorbed within the range of 80% – 125% of the original compound. That is a huge variance.
The problem with that range? This means that the original Ritalin SR could likely meet criteria to be a generic for Concerta.
If you’ve been around long enough to remember Ritalin SR (or if you have not had insurance so it was the most cost effective medication option), you’ll know that Ritalin SR was widely found to be a very ineffective long acting medication. It often did not last longer than short acting methylphenidate in most of my patients. Most of the doctors in the field considered adding Concerta to the medications available in Canada to be a huge improvement, because we could get away from Ritalin SR and its poor efficacy.
I have been unable to get any scientific data (and neither have any of my colleagues) to demonstrate how Novo-Methylphenidate ER-C works. For all we know, it could work like Ritalin SR – which essentially means that it won’t work very well at all.
Concerta has a lot of technology in each little pill. Each pill has a laser drilled hole in it. There is short acting Methylphenidate on the outside of the pill, and then there is an osmotic capsule (meaning that water can come into the capsule from the gut). The water from the gut comes into the capsule, and expands a polymer, which then pushes the medication out of the pre-drilled laser hole – in a researched process which delivers the medication in a fashion which has been shown to work best for people.
Has Novopharm invested what is needed to develop this complex a medication delivery system?
No – they haven’t.
2) Will you be able to control which medication you get?
Let’s say a member of your family is doing very well with Concerta as a treatment for their ADHD. Now that there is a generic product – can you guarantee that you can keep this product as your monthly medication?
As of late April 2010, the Ontario government has deemed Novomethylphenidate ER-C interchangeable with Concerta.
When a medicine is deemed interchangeable, then pharmacists have an obligation to automatically substitute the generic form of the medicine for the brand name version. in other words, your pharmacist will have to substitute your Concerta with Novo-methylphenidate ER -C.
There are a couple of factors which can impact whether you get Concerta or the Generic:
- Your insurance: your third party medication insurance may decide that to save cost, they insist that you take the generic Concerta, and they may not cover the real Concerta. If the generic doesn’t work for you, you may have to either pay for it out of pocket, or just stick with the generic.
- If you are on a government provincial drug plan – they may insist on the generic version, and not cover the name brand Concerta any more (Ontario has just forced automatic substitution on their plan).
- What your pharmacy carries: some pharmacies may order in ONLY the generic version, and stop carrying the name brand Concerta. In this case, you may have to go to another pharmacy to get the medication you need.
- How your doctor writes the prescription: If your doctor just writes the prescription for ‘Concerta’, the pharmacy can substitute it automatically for the generic. If your doctor writes the words: NO SUBSTITUTION on the prescription, then the pharmacy will have to give you the name brand Concerta.
Pros of Generic Concerta:
- If this generic works well, then this means there will be a lower cost long acting medication option for people who can’t afford the more costly brand name Concerta. It seems that the price reduction is in the range of 50%.
Overall, as you might have gathered, I feel very uncomfortable with the Generic Concerta at this time (Novo-Methylphenidate ER-C). Most people that I see in my office have had a long and/or challenging road to get to the diagnosis and treatment of ADHD. Often taking a medication for ADHD is a huge decision, and arriving at a medication which works well with few side effects is beneficial and often a relief for concerned parents and family. To have that medication changed and become less effective would be very detrimental to my patients – and create a huge disruption to their lives.
Will Novo-Methylphenidate ER-C work well?
I don’t think anyone knows right now. Where is the scientific data?
I don’t know anyone who has seen it yet. And despite this, pharmacies across Canada can start stocking this and replacing it for regular Concerta (and they don’t even have to get your permission).
What do I recommend you do if you or a family member take Concerta?
- Ask your doctor to write a prescription for Concerta NO SUBSTITUTION (it doesn’t have to be capitalized – I am adding that for emphasis). Your doctor can even write: No Sub (which is faster!). It has to be in handwriting. If it is a stamp, or some other form of automated process, then the pharmacist can ignore it.
- Talk to your pharmacist about this – to check if you can still get the name brand medication
- Look closely at your prescription bottle – to see if the medication is: Concerta, or ‘Novo-Methylphenidate ER-C’
- If needed, check with your third party insurance for medication – to see if you are still able to get the name brand Concerta covered
- If you start to notice that Concerta isn’t working as well as it used to – look closely at the bottle, and realize that your prescription may have been substituted for the generic.
As this is a significant change to medication for ADHD in Canada, and one which came as a surprise – I wanted to provide you with some background. I’ll be happy to update this blog as more information comes out, and I know more about this.
One of the things that has been very helpful to many people on this blog – is that readers like you share their stories in the comments below (as you saw with the link about Adderall XR going generic in the US). So, I ask you to share your thoughts, experiences and comments below. Let’s help one another figure out how this new medication works, as well as what is going on in pharmacies, and with insurance coverage, etc. Thanks in advance for your contribution to this post.
Janssen Ortho Releases A Program To Help To Keep You on Brand Name Concerta:
Janssen Ortho is the company making Concerta. They have invested a lot of resources into developing Concerta, as well as educating doctors, educators, and patients and their families about ADHD and its potential impact on people’s lives.
The acceptance of the generic medicine as ‘interchangeable’ is leading to people being taken off of Concerta and being put on the generic very quickly.
Janssen has created a program which can help you to stay on the brand name product. It is called the: “Concerta Co-Pay Assist Program”.
What happens is this:
- You get a prescription from your doctor that says: Concerta No Substitution
- You go to the pharmacy, and give in the prescription – and insist that you get the brand name product.
- If the pharmacy says that your insurance will only cover the generic product, and you have to pay the difference – then you give the pharmacy a ‘Concerta Co-Pay Assist Card, and then Janssen Ortho will pay the difference between the generic medicine and the brand name medicine.
In other words, when you give one of these cards to the pharmacist – you won’t have to pay any extra above the costs of the generic medicine. This applies whether you are on the Ontario Drug Benefit Card, or whether you are on private insurance (i.e. from your work), or even if you are a cash payer.
Here is an image of the card:
You’ll notice that the card says: ‘Multi Use Patient Co-Pay Assist Program’.
This means that you can use the card over and over again, as long as you are taking Concerta (and as long as Janssen continues to run the program – which seems to be for the duration at this time). Logistically, you can either leave the card at your pharmacy, or take it with you – just make sure you still have it when you need to refill your prescription.
Now the big question you may have is: where do you get these cards?
These cards are being give out to doctors, as well as to pharmacies. So, ask your doctor if he or she has a card for you. If he or she doesn’t, you can either ask at your pharmacy, or ask your doctor to contact his or her representative from Janssen Ortho to get a card for you.
Hopefully, it will be easy for you to get a card to continue on the brand name Concerta.
***Please note – that at this time – these cards are only available in the following provinces: British Columbia, New Brunswick, Newfoundland, Nova Scotia, and Ontario,.
Another Update: Potential For Abuse:
One of the risks with Methylphenidate medicines is that the medicines can be abused. Kids in school yards can sell ritalin (or short acting methylphenidate medicines) for $5 per pill. Many people will take the tablet – and crush it, so that they may snort it. When they change the route of delivery to the brain (i.e. when the medicine is absorbed via the nose vs. via the stomach), it can increase the speed of the medicine getting to the brain and it can then increase the abuse potential – i.e. people can get a ‘high’ from it when they snort it.
Concerta has a polymer inside, and a hard outer capsule. When it is crushed, there is no powder which can be snorted.
However, the Novo-methylphenidate ER-C can be crushed easily.
Look at the picture below which shows two 54 mg capsules – Novo-Methylphenidate ER C on the left, and Concerta on the right.
You can clearly see that the Generic medicine is easily crushed into a powder which could increase the chances of the medicine being abused.
There are studies done which show that with Concerta, there is less risk of abuse. There aren’t any studies done on Novomethylphenidate ER C yet, but, as they say – a picture is worth a thousand words. This picture shows that it can be crushed into a fine powder – thus increasing the risk of abuse.
p.s. regarding dosing – Novo-Methylphenidate ER-C will be available in the same doses as Concerta:
- Novo-Methylphenidate ER-C 18 mg
- Novo-Methylphenidate ER-C 27 mg
- Novo-Methylphenidate ER-C 36 mg
- Novo-Methylphenidate ER-C 54 mg
p.p.s. A comment from me about this blog post: I am not being reimbursed by Janssen Ortho for this blog post. I do not own any of their stocks. I use this blog to post my opinions and to share updates to science, research and general ‘goings on’ in the field of ADHD. That is what is happening here. I happen to feel very strongly about the generic Concerta not working as well as the brand name product – and that is why I am working hard in my office to support people staying on the product, and using this blog to get the information out to a broader audience as well.