After advising caution regarding generic medications for ADHD here and here, I’m now hearing that Concerta is recently available in a generic form in the United States. (A generic has been available in Canada for some time, but it is a different type of generic.) The question: Does this generic perform as reliably as Concerta? Maybe. In fact, it might be the exact same medication.
Original Concerta, 54 mg
The details are hard to come by in a field swimming with lingo: co-licensed product, single-source generic, authorized generic, bioequivalent and clinically equivalent. My conversations with pharmacists and the manufacturer’s scientific liaison leave me thirsting for straight talk with no tricky qualifiers. Internet searches and first-person reports in online forums are made murky by the apparently marked difference between Canada’s generic Concerta and that in the U.S.. (Forum participants seldom specify where they live, presumably because most don’t realize there is a difference between the two countries’ generic versions of Concerta.)
The U.S. generic for Concerta is methylphenidate hydrochloride extended-release tablets. It is a co-licensed product by exclusive agreement — that is, a deal between the original manufacturer (Ortho-McNeil) and the pharmaceutical marketing arm of Watson Laboratories.
Both brand-name Concerta and the so-called “authorized generic” are manufactured in the same plant, said the Ortho-McNeil spokesperson by phone. And, this authorized generic is both bioequivalent and clinically equivalent. Does that mean it’s the exact same medication? I think so, but I cannot be absolutely sure at this point, as I am battling a persistent cold and very busy readying for the CHADD conference in Orlando.
According to this FTC report on generic drugs, it does appear to be virtually the same product:
An authorized generic is a lower-cost, generic-label version of a brand-name drug that is already sold by the same manufacturer. The Hatch-Waxman Act is designed to ease the introduction of generic drugs by, in certain circumstances, granting a 180-day period of marketing exclusivity to the first generic competitor of a brand-name drug, known as a “first-filer.” During that exclusivity period, no other generic company can receive FDA-approval to sell its product. However, this marketing exclusivity period does not prevent brand-name companies from introducing their own authorized generic versions.
According to a press release from Watson Laboratories, the first patent for Concerta is set to expire in 2018. Thanks to a legal settlement between two pharmaceutical manufacturers, however, a generic version became available much earlier, in May 2011. Due to the settlement, Watson Laboratories is allowed to sell an “authorized generic” version of Concerta.
Here is the apparent bottom line: The original manufacturer, Ortho-McNeil. supplies Watson with brand-name Concerta tablets; Watson packages and sells the tablets as a generic drug. That means the generic version is exactly like the brand-name Conceta in every way, except in price. For example, our mail-order pharmacy was charging $120 for a 90-day supply of Concerta; for this authorized-generic version, the charge is $20. Quite a savings if the results are the same.
If you have solid information to share on this topic, please do! Just scroll down; no registration or annoying codes!
Tags: ADHD medications, generic Concerta
-
Hi Gina,
My son has been on Concerta 36 going on three years now and has been doing extremely well. He has diagnosed ADD with the major component being impulse control. He is an identified gifted child making A’s in all advanced classes, currently he is in the 7th grade. Last summer all of a sudden we noticed the impulse control issues were back. It was as if he needed a higher dose of Concerta. I became concerned that the pharmacy mistakenly gave us the wrong dosage so went to check the bottle. It was the generic… we had not known we were given the generic before I checked halfway into the month (I know, irresponsible on my part for not double checking) Anyway, I called the pharmacist who assured me it was the same med. I called the doctor who said it is supposed to be the same so she was also at a loss as to why. We got a new script written expressly for brand and things have been fine since… UNTIL…. this year my insurance is now making brand Concerta financially difficult for us. We asked for the generic this month, with immediate changes in behavior. This time I know its generic so some people might say its the placebo effect, but given our previous experience I truly believe the generic does not work as well as the brand for MY son. I don’t know why and definitely would never say its the same for everyone but for my child, the brand works better. With or without prior knowledge of generic, his behavior is different. I’m going back to brand Concerta even at $109 compared to $25 for generic… my sons future depends on it.
Hope you find out something to help those of us who do notice a difference when nothing is supposed to be different….
Donna
-
Hi Donna,
I don’t know what to tell you. If it says Alza and looks like the images of brand Concerta that you can find on the Internet, it IS the brand.
There is apparently no way that could be copied and sold through a pharmacy.
You sound emphatic, though, so I just have no idea what could explain this.
There is another “generic” coming out….I’m still researching it, because I can’t see how the delivery system is anything close to Concerta. It’s just a pill. No osmotic pump. So, when insurance companies see that cost-savings, I’m afraid it will get worse for people who can afford only the (true) generic.
I will post about it soon. Still waiting for info from the company.
-
Donna could be describing my son exactly. He’s also 7th grade, gifted, A-student who has been doing well on Concerta Brand and also the Watson Generic. Last month our pharmacy switched to the Mallinkrodt manufactured brand and everything changed. His impulse control & focus issues were back with a vengeance. He noticed a marked difference in the effects of the medication throughout the day, and told me to PLEASE find the old medication.
I’ve done some other research and according to the press release for the Mallinkrodt product, “the FDA found that our long-acting technology delivers a dose which is therapeutically equivalent to what is currently on the market.” I disagree completely with their statement. If you have found similar issues with their product, please notify the FDA here: https://www.accessdata.fda.gov/scripts/medwatch/. It is the only way we (as consumers) can have an impact. -
Thank you, Julie.
-
-
Sorry… adding on to my previous comment… we are in the US and my generic DOES say alza36…
Donna
-
We got my 12 year old son his normal 30 day prescription of generic Concerta. Worked great last month. Got a 90 day prescription recently from Watson Pharma. It’s as if the medication no longer works. It’s as though he had stopped taking it. But, we’ve been adminstering it daily. The psychiatrist indicated that sometimes the dispensing mechanism(osmotic pump in the capsule) doesn’t work and providing a new prescription can solve the problem. Does anyone know which of the three generic manufacturers(Mallinkrodt/Methylin, Sandoz or Watson Pharmaceuticals) works the best?
-
Doug, if you received the Watson “generic,” you received the brand. It’s “generic” only through a marketing agreement. You might want to read my posts on the subject.
If it did not work, I would return it to the pharmacy and ask for another. But I’ve never heard of the osmotic pump not working. Could be true; just never heard of it.
The Mallinkrodt “generic” is in no way anything like Concerta. It’s basically Ritalin LA. I am trying to get information so I can write up the details on this. Needless to say the companies aren’t forthcoming.
I don’t know about Sandoz. If they make the generic Concerta in Canada, I’d avoid that one, too. It’s not anything like the brand.
-
Four days ago, my pharmacy gave me a generic (Mallinkrodt ER 27mg) instead of Concerta for my 11 year old. It does not seem to be working, or working inconsistently.
My child has become very forgetful, difficult to deal with and is unable to fall asleep at night. We did not experience any of these problems with the Concerta.
Mallinkrodt’s ER 27mg tablet is a completely different shape from the Concerta tablet and may not be dissolving properly. I also suspect the formulation is different. I just did some searching on the internet and learned that Mallinkrodt just started manufacturing and selling this medication this year after receiving approval in December of 2012.
I am going to call my pediatrician tomorrow and go back to Concerta.
-
Thanks Jeanne. This is worrying, as many people will not be informed and will simply think that the medication doesn’t work (or worse, it’s not ADHD).
If you can take the time to complain – to anyone and everyone – that might do some good.
best,
g
-
-
Gina, sincere thank you for your quick response. Based on what you said, I’ll ask the doctor for another prescription and see what happens. Thank you so much once again.
-
Good luck, Doug. I just don’t know what to make of these reports about the “Alza” generic not working. I’ve contacted the FDA and other sources to see about the chance of counterfeits. These things are tightly controlled, and the Alza OROS would be hard to duplicate with any kind of authentic look. So, I just don’t know.
I do know that some of us will be in worse shape, when insurance companies start charging an even bigger premium for the brand and forcing people to take the “generic” — especially with this Malinkodt …..garbage…that is basically Ritalin LA. They’ve exploited the letter of the FDA law, it seems to me, in showing bioequivalence with Concerta. Shameful stuff, in my opinion.
-
-
Hi Gina-
I’m glad to have come across your info on generic v. brand or good generic v. bad generic. I have noticed the grades slipping from straight A’s to B’s with difficulty. Still, I am not complaining. I am hugely concerned with the shortage of the Meth 20mg ER. It appears to be a national shortage of raw materials. Any suggestions???
I also want to ask how can I get a 90 day supply by mail when 1) it is a controlled substance and requires a script in person 2) my MD or my mail order pharm (can’t recall which) has said I can only have a Rx for 30 days at a time. I live near Chicago, IL. Am I getting bad info?
-
Hi Tony,
I haven’t kept up with the shortage controversy. Last I heard, it seems that the DEA has decided there will be limits on the “raw materials” for the stimulants, no matter how many people are diagnosed legitimately. Talk to your congressperson.
re: 90-day supply, this might or might not be a feature of your insurance company’s prescription plan. Ask ‘em. We send in my husband’s Rx to Arizona from California (previously, it was Texas, I think). Somehow, mail-order is different. You do have to send in a new script each time; no refills.
-
-
My son just started taking Concerta last month. Today I tried to refill for the first time, and the Costco pharmacy gave me half pills that say Alza 27, and half that say M27. They pharmacist said they are in the process of changing brands. The first time I filled the prescription they looked just like the Alza ones, but since they are gone now, I can’t remember what was imprinted on them. I felt really uncomfortable about the M27 ones. When these were prescribed, my doctor told me that the effectiveness of these pills were because of the pump, so to see the tablets that didn’t look like there could be any sort of pump in them, I felt extremely uncomfortable using these pills. I am not sure what to think of this. I didn’t get a chance to go to a different pharmacy tonight, but I hope that when I do go, that they will be the Alza ones. I am very confused on all this. Are pills marked Alza not generic? Are they sometimes? How can the medicine be just as effective as a tablet when supposedly the pump is what helps create the even dosing throughout the day? So frustrated and confused!!
-
HI Roseann,
Thanks so much for your report from the front lines. This is exactly what I’ve been fearing, this so-called “bioequivalent” substitute for Concerta that is really nothing more than Ritalin LA. It’s an outrage. I will be writing more details about this soon. If it were me, I’d take those M27 pills back to Costco and say that was a mistake; you need the Alza 27. And make a big stink.It is possible that your child will do okay on these Ritalin LA-like generics, but I sure would not bet on it.
Frankly, I’m angry at this manufacturer’s cynical, craven exploitation of people with ADHD for their mining of FDA loopholes. Shameful. I’d like to mount a nationwide boycott.
Stay tuned.
g
-
In response to Gina on May 17 (I can’t see how to respond to your comment)
That’s actually what I did. My husband was the one who filled it, so when he brought them home and showed them to me, I immediately called the pharmacy. They tried to tell me it was fine. I took them straight to the doctors office, and they said to take them back. I did that, and the pharmacist was adamant they were fine, but finally said he would refund my money, but couldn’t take the pills back, but that I needed to take the pills to my doctors office and give it to them. He did reverse it on my insurance too, so I can still go get a new prescription of the correct stuff (in my opinion). I felt extremely stupid, but stuck to my guns because I really didn’t feel good about the M27 stuff. He even called my doctors office while I was there and got after them. He was apparently talking to someone different than I talked to, and he had that nurse talk to me. She was actually quite rude and made me feel even more stupid for not listening to the pharmacist, and that I was costing the pharmacy a lot of money, but in the end I was able to stick to my guns and say that I really wanted to take my prescription somewhere else. Once I left I felt so glad I stuck to my guns, but still felt stupid at the same time. I returned to the doctors office to give them the prescription and get a new written prescription, and the doctor and nurse there that I talked to reaffirmed that I was in the right. They made me feel better, which I was so thankful for!
-
Woo-hoo Roseann – you’re my girl! And you’re not stupid — you’re smart. Very smart!
Some day, we might not have a choice if we want generic Concerta; this poor M substitute might be our only choice, if we cannot afford the brand. In the meantime, the marketing agreement with Watson still holds to sell the brand as generic. So, if Costco is cutting corners already, I’d take my business elsewhere. That Costco pharmacy is simply buying the party line that the the M generic is just as good as brand — and want you to buy it, too. But consumer beware!
We use a mail-order pharmacy, via our healthcare insurance. Might be worth looking into, if your policy features it.
-
-
It took some work, but I did find a pharmacy that carries the Watson Generic Concerta that says alza 27. It was Walgreens that still had it. I tried a Kroger pharmacy, which was the place I used the very first time I filled the prescription, but apparently they too just changed to the M27. The technician or pharmacist that I spoke to at the counter was very helpful, yet not entirely helpful. He looked up on “facts and comparisons” information about the M27. He couldn’t actually figure out what the new delivery system is in this new pill. He couldn’t find anything about the osmotic pump. He did find a chart that showed a pharmokinetic curve nearly identical to what I found on Medscape for Concerta. That’s at least comforting, but I still wasn’t comfortable with going with that option yet. So I told him I would keep looking and fill the prescription somewhere else. I’m curious over the next month or so to see what else I can learn about this.
-
Good for you, Roseann. I’m skeptical of that pharmokinetic curve. Everything I’ve been able to find out tells me this is basically Ritalin LA, which is not as sophisticated a delivery system as Concerta. Not at all.
Stay tuned and subscribe to my blog. I’ll have a post about it soon, and maybe others will weigh in. tx
-
-
My step-son is on Concerta36 (brand) for the past 4 years. He’s been doing excellent on his meds till about 2 months ago. He’s all of a sudden got hectic mood swings, aggressive, depressed, happy – it’s a total roller coaster. Can it be that the mg needs to be increased and not strong enough for him anymore? If yes, why all of a sudden the change?
We’re staying in South Africa, and no generic is available here yet – thus I can’t even say that we’ve been given that.
-
Hi Anina,
There are many possible reasons why the medication might not seem to be working as well.
You don’t mention his age or other lifestyle factors, which are part of the equation.
But there are other factors. I write about medications for ADHD (which has many “traveling companions,” such as depression/anxiety) http://www.amazon.com/dp/B0050JCA7C/?tag=wwwginaperaco-20
Best,
g
-
‹ Previous · 1 · 2
115 comments
Comments feed for this article
Trackback link: http://adhdrollercoaster.org/the-basics/whats-up-with-generic-concerta/trackback/