Generic Concerta in Canada
By*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?
Not necessarily.
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.
New Updates:
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: Ontario, British Columbia and New Brunswick.
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.
Generic Concerta versus NovoMethylphenidate ER C
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.
Best,
Dr. Kenny
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.
I just started the generic last month. i didn’t know about any of the controversy aside from a quick chat with the pharmacist. I am one of those people who did not find Ritalin SR helpful, and I am finding this new generic to be almost identical to SR. I find it agitating, with a very heavy “kick” when it first gets into my system. My wife says I’m much more irritable in the morning as it kicks in. I notice it wears off 6 to 7 hours later with a noticeable crash (I actually get a bit sleepy in the middle of the afternoon, which I DON’T with concerta.
I gave it a try for more than a month, but have now filed an adverse report to Health Canada (the agitation and irritability) and will be asking my doctor for an early refill specifying real concerta. I’m not a fan of drug companies normally, or of patented medications but Concerta works, and that is not my experience for myself with SR or this new generic.
THIS is BAD now. end the MADNESS.
Dr. What the heck ?
what do we do ?
this is no joke eh …
so …
?????????????????????????
I would like to know the courts reasoning for overturning the patent before it was up.
If it’s all about money I think the people who suffered the consequences should get a share in the money as well.
I also wondered about the ability of a ‘generic’ drug’s delivery system to match that of the ‘original’ since the innovative delayed delivery method of Concerta was one of its marketed superior benefits. I didn’t have to wonder very long if there would be a difference.
A few months ago my Wal-Mart pharmacy refilled my Concerta prescription with the ‘generic’ because that is the ‘law’ in Ontario. They said they could change it if I insisted and that Concerta would pay the difference between the two. I was in a hurry and didn’t have time to wait so I said if the pharmacy was sure that the ‘generic’ worked the same I would take it.
They said that there had been no reports of any ‘differences’ between the two and that they had a few patients on the ‘generic’ who had not mentioned anything. (Well in hind sight, I’m thinking those folks may not really have ADD and need the meds or else my brain is really wired way different than them!)
For me, THERE WAS A HUGE (NEG) DIFFERENCE!
I noticed the difference immediately but thought I might be experiencing a type of ‘reverse placebo’ affect meaning that I was consciously looking for differences and was imagining the following differences:
1.Extreme foggy thinking ( even worse than before diagnosis of ADD) and spaciness.
2. Increased lethargy and tiredness.
3. Stuttering (which I have never experienced in my life!) and difficulty in forming my thoughts into sentences and inability to find the right ‘words’.
I gave the ‘generic’ a fair 4 week trial and the above-noted side effects never relented.
I went back to the pharmacy and explained my situation and offered to draft up a feedback document to give to them but they didn’t need (or seem to want) the feedback.
They switched the remainder of the ‘generic’ for ‘Concerta’ and I noticed the difference immediately +postiively.
It is outrageous that our Government is allowed to mess with our minds like this (no pun intended). I thought maybe I was a ‘rarity’ and perhaps imagining the differences and hadn’t reported anything to the drug regulators.
After reading this blog, I realize I was not imagining my side affects so I will report my stuttering and excessive tiredness due to the extreme level of distress they caused me during the month I was a ‘team player’ and agreed to be guinea pig for an ‘INFERIOR GENERIC”. Never again.
We all need to say NO to generic’s if the orignal, brand name is working for us. Especially if the ‘generic’ has been approved in contradiction to supposed patent protection.
It probably wouldn’t take long to find the ‘paper trail’ ($50′s and $100′s would be my guess as a start) that allowed the generic to be deemed ‘interchangeable’.
Karen
My pharmacist recently gave my daughter the generic instead of her regular Concerta and assured us that it would be the same. I’m finding that it isn’t. It’s not a horrible debilitating difference, but it’s there. The generic doesn’t last as long, and there is a more noticeable rebound when it wears off. For about a half an hour in the evening she is running/rolling around, faking laughter and flapping her arms. She’s having a hell of a good time, but it’s a little annoying for those around her! Thanks for this blog post, I appreciate seeing all the information so clearly presented. I think I’m going to talk to the pharmacist/doctor and ask that she go back on Concerta. We’ve given this generic a fair shot for nearly a month and I just want to be back to what we were originally comfortable with. As you say, we’ve gone through many meds to find one that is just right, and a dosage that works, and I really don’t feel like playing around with it when it isn’t necessary.
now, as sad it is to say,
this may one of the few , if any who is even saying ANYTHING about this in the last months since this bull has been started.
lets be real about this now ok.
1) these are “controlled-substance” medications … ( no matter who you are, they always make a face …. on top of our current problem, they [ the pharmacists ] will never care, nor budge to do anything about it.
2) Doctors ( MD’s ) are even lucky to give you your medication as it is… even, yes !.. for your children or perhaps yourself who actually DOES NEED the HELP !…
3) After that, … with this new information, its so out of whack for our Doctors to even think of such things… ( Insurance, pharmacists giving you to work-around,.. ) etc …
– when all they have been doing and we have been even luck at this point for any of that all to this point .. provided the medication that we so desperately need to help with our every day life .
Its hard to explain this in simplest terms but.
1. not enough information has come out since these ridiculous and radical changes with medication costs and generic bullsh*t …
2. most doctors, the few that even care to help for people that really DO need this help and prescribe stimulants ( thank goodness ) … would not know any quicker than we would in a one website such as this.
ok I will. stop ranting.
but let me just say my OWN personal latest experience.
my girlfriend who has been trying to take Concerta ( name brand ) consistently for not even 6 months yet ..
NOW .. she has been covered 80% from college … for ANY medication.. Ontario Works, does not cover Concerta ( because it is new, etc )
anyway.
but NOW… she had Concerta covered 80% for 4 months now, and out of NOWHERE … the pharmacist now said , well we can cover it, except, you just need the doctor to said ” NO SUB ” on it.
I mean, she was able to get name brand without no sub. but for the INSURANCE company .. for whatever STUPID reason, they had to see “NO SUB” on the prescription, for it to be processed.
now, im sorry, we have heard many stories from different pharmacies stating they had to have no sub just to have the name brand prescribed, that is simply not the case. now just to have it covered.
her Doctor argued about it.. with HER … and I dont blame her, because she probably does not know what happening herself.
and it should NOT be the patient and doctor arguing about something silly like this.
and for what ?
to get the medication she should have expected all along ?
ok look politician screwheads. If you want to allow things like this.. generic brands of something.
you better get something placed and planned for the contingency throughout all the actions in this Country after the decision made from one silly court ruling.
Dr. Kenny.
what do you have to say about this now ?
obviously this is getting worse.
what do we say to our Physicians ? we should not even HAVE to complain. its not our place. but we would feel compelled to disclose all this information if they have not known this going on in the last year.
it makes me sick, and I for one do NOT feel I have to be the patient to explain these things to my doctor, when all my doctor should be doing is understanding my condition/symptoms, and continue helping me through our treatment and prescriptions.
so…
what can we do. ( thinking outside the box )
this IS going to get worse.
we could be the people to begin speaking out and doing SOMETHING.
could we ? can we ? please ! may we.. before I throw up
thank you friends
Dr. Kenny? =-)
This comment thread has grown quite a bit, and I wanted to chime in.
Thank you to all of you for sharing your experiences. As DJ just pointed out, often times, Doctors don’t know what is happening, and it may fall to you to explain these issues. I am honoured that my blog post can inform you, and also give you the forum to share your experiences, which are arguably more important and significant.
As of today – August 27, 2010, there is no progress to reverse the decision.
I have provided education and talks/speeches to many parents and many doctors (and many pharmacists). The fact that DJ’s girlfriend got the brand name because the pharmacist offered the card – suggests that the education that is being done is starting to work. Not completely, because the doctor didn’t know about it, and the patient had to educate the doctor.
In so far as what we can do?
Consider getting active with CADDAC (www.caddac.ca) the Canadian Centre for ADHD Advocacy. They are working on this issue.
While I would love to say that there is a fast and easy solution – I don’t know that there is, and I just advocate for education so that people can know what is going on, and know their options!
Thanks to all of you for your contributions.
Dr. Kenny
Thank you Dr. Kenny.
1. they are making changes every day it seems, every month we go for a refill its something new from these pharmacies.
now, for the first time, our College Insurance plan would not cover the prescription ( 80% ) like it has for years… UNLESS the prescription specifically stated NO-SUB.
yes people have said the same already here, but this was never an issue for us EVER. until one recent refill, they came out of nowhere to say that.
what does a good patient do ? call the Doctor and hope that he/she can be merciful and simply call in to the pharmacy to add the NO-SUB in real quick.
( yes, and for me at least, I know most Doctors never call in controlled-substances ever.. to a pharmacy )
but for my gf at least, she did though. BUT .. upon calling her and explaining it, she , surprisingly, turned completely the other way. as if she could not be bothered with such things, and then .. yes, even questioned why my gf could not just deal with the Generic ?
now, that is not acceptable though.
I know my Doctor will understand all this once I see her next in a few days to get another 3 month prescription refill
but when I explain this, she will tell me exactly what is happening. My Doctor is ok, Ive been with with them long enough.
but thats me, and 1 our of … 1000+ ??
and everybody lets please not forget that we are actually dealing with controlled-substances ( narcotics ) .
It has taken so many years just to alleviate a little bit of stereotype or what have you … to even begin with the validity concerning Adult ADD. at ALL .
and NOW, we were getting this.
thank you Dr. Kenny. We will check out that website you mentioned.
but I still feel this is a great resource to continue discussion.
this is new and going on every day as we speak ( or type
)
so we need to have this place here.
[ I am 28 yr old, use to be on 4 x 20mg Methylphenidate and then 1x 54mg Concerta + 1 x 36mg Concerta ] for over 10 years.. yes I am at the max dosage, currently slowing down to quit finally
my levels are ‘thank goodness’ evening out so I can stop finally 
but you can understand that I have known and researched myself and with my Physician as much as I could to know what we, as patients have to deal with. at least for this one, simple lack of one’s brain main function element 
anyway.
this has gotten me excited, and I hope all here will now follow or push more effort into getting involved. ( this is LIVE, happening NOW… so NOW we can start trying to do something )
btw, I am in Canada. Concerta just came here years ago. still not covered with government. but anyway.
now lets get busy
thanks friends =-)
- DJ
Today I went to the pharmacy to fill my son’s Concerta order from his Doctor. The pharmacist gave me generic pills and I questioned this.The pharmacist informed me that the generic and the original versions are identical in drug content and in mechanism of delivery.That we all know is nonsense. The pharmacist was completely uninformed about the trilayered Concerta pills which have worked brilliantly for my son and there is no way I am going to mess with something that took a long time to figure out. There is more at stake than saving a few pennies, his education, his life, his attitude, everything, will be thoroughly disrupted by changing his medication.
Thanks for the info
and that is basically the entire issue at hand right now.
they can do the Generic stuff with other meds, but for this medication… because it Is a stimulant, it is so dangerous and must be taken very very carefully.
only because this medication is considered a “narcotic” or “controlled-substance”, after all these years to overcome a lot of the challenges for decades from everybody’s bias views towards not only the medication, but ADD in General.
and NOW, we are given this bull. ( Generic medication substitutes ) . and with pharmacists who never know anything anyway but are actually trying to tell us things that we obviously know is a complete lie.
so. 1. who is making them tell us this ?
2. what is the big deal.
3. Dr. Kenny gave us a reference, and I will be checking it out this week, so I hope you will all join me then. this is just too serious to ignore, and Sue, you really hit the nail on the head about your son’s condition ” his education, his life, his attitude, everything ” . this is why this can not continue.
at least not for these meds.
every patient needs to live their life and changing medication, again, especially with stimulants such as these, are never suppose to be changed so abruptly as it is. ( Ritalin to Concerta or vice vera.).
so the fact that pharmacies will just next month give you a Generic brand as if it is the same, when its already established to be even worse…
its not safe. its not tested. its cheaper. but, its – NOT – THE – SAME !
forgive me if I sound like a ranting rampage, but we are going to have to start somewhere. this has just blown up lately. so we can try to do something ..
http://www.caddac.ca
lets get it going now
now is the time
=-)