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.
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.
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Tags: ADHD medications, generic Concerta
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My husband has been on the exact pill, same dosage and everything, and I haven’t noticed any changes. He seems to have not noticed that he’s taking anything different either, he didn’t know it was a generic. So I don’t know when it changed. He’s doing really well and has been working very hard as of late.
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Whoops, he’s on the exact pill you used to illustrate the blog post with…
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What’s up with stimulants?
Good article, and important too. I need to get my Rx changed from Adderall (generics OK) to Concerta. I haven’t been able to get my “amphetamine salt combo” prescriptions filled at any local pharmacies in Raleigh, NC since last Spring. Without the Adderall I feel like I’m swimming in peanut butter! My pharmacist said “the manufacturers didn’t make enough pills to satisfy the demand” and “the raw materials to make the medicine is are in very short supply, across the country, hence the shortage”.
I’m not blaming my pharmacist, but I wonder if you know anything about a nation wide shortage of stimulants, and also drugs for several other categories of health issues, like cancer/chemo drugs.
PS – I’m in the Triangle Adult ADHD MeetUp Group, the largest Adult ADHD MeetUp in the world, and everybody I’ve talked to has this problem.
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The generic, in this case, is only different in classification. The generic “Methylphenidate ER capsules” sold by Walgreens in California are the identical drug to the name-brand– they both carry the Alza brand, and my pharmacist assures me they are identical. (He knows about the differences between generics and name-brand due to an unfortunate issue my wife had with generic Allegra)
Unfortunately, even though the generic is a tenth the price, we still pay the non-generic copay on it because the drug is still “non-formulary”. Feh.
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I gladly went to the generic as soon as it was available (MA). Saved $30 a month in copay, and no apparent difference in effectivity!
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I’m happy to find someone talking about this on-line.
My 8 year old was on Concerta 18 MG for one month for ADHD and the second month the pharmacy gave me the generic and assured me I would see no difference.
Day 3 and 4 of the generic meds (after the weekend) and he’s having issues in school. Not getting along with friends, crying over spilled water, not having as much self control, etc.
It’s so hard to know if this is a blip in his treatment, if he needs a higher dosage or if it has to do with the generic.
I called his doctor and she’s writing him a new prescription for Concerta (the real deal) but after reading this, I feel like we’re in a loophole of sorts Can you give me any perspective on how to advocate for my son?
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sally,
I had the same problem with my 9 year old boy. He was on concerta and we tryed the generic. He didn’t like it, said he could tell the difference and it didn’t work as well. Now his insurance said they wont cover anything other than the generic. Now I need to find another medication to put him on. I hate to do that because concerta works so well for him.
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Thank you, Gina, for your reply.
The pill says alza 18 and looks identical to the Concerta he was on last month. And we’re in the U.S.
So it’s sounding like what I need to do, is go ahead and fill the “real” Concerta (even though it’s the same) – and then we can rule out that his issues at school are not “generic” related but rather dosage related. Hopefully in a couple weeks we can get him on the right track.
Thankfully my insurance company has no problem with me refilling it, and my co-pay is the same.
It’s never easy, is it? Thank you for your thoughts, even though your primary focus is adults. I truly appreciate it.
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I met you at last years Atlanta Conference. I wish there were many many more people like you who have a good grasp on what it’s like to be
ADHD and also how it relates to interactions with others.My past experiences with medications have been horrible. Through many “Professionals” I was constantly being told I was depressed, and went through the list of antidepressants, every few years, dealing with a frustration in life that I had no clue, as to the cause. Finally, after a nephew was diagnosed, I was encouraged to get tested (at age 52). Even after being diagnosed, I went through cartwheel inducing Adderall, followed by a dizzying drugged down feeling ending with my first and only panic attack under Wellbutrin.
After reading more about ADHD, I suggested I try Ritalin. It was not immediately clear if it was working, but slowly I noticed that I was getting more done in less time, with less emotional effort. Much like I did when I was running 6-10 miles a day. (another story). I was on the short term (about 4-5 hours for me) generic Methylin. I later moved to the longer lasting generic Methylin ER. Both it worked great. Then the pharmacy switched over to the Metadate version. I found myself, struggling a bit more in the morning, ok near lunch, but in the afternoon, I found myself getting very talkative and often somewhat agitated. I went through about 20 days before I said “this isn’t right”. I explained what was going on and struggled to be believed. It was an awful feeling to be told that what I was saying couldn’t be happening, because it was the “same medication”. I firmly refused the Metadate version and even had to go out of state to get the Methylin ER when there was a shortage. I have now tried the Methylphenid ER version which seems to act identically to the Methylin ER. From your information and the conference last year, I now know so much more about myself and that how things affect me, may not affect others in the same way and that’s just the way it is.
One of your best analogies, to help others understand how ADHD is for me, was from a video you did regarding cookie cutters. There is no one description or cookie cutter that fits us all.
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I’ll add another data point for not even noticing when I got switched to the “generic”. It’s so nice to pay less and not get screwed at the same time!
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Has anyone had any trouble filling either Brand name Concerta or Generic version. I was just curious as what to expect on my next prescription. Thanks
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Thanks so much, I guess if I call the pharmacy about a week before hopefully that will be enough time to see if they might have Generic Concerta or not.
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Hi my 9 year old son had been on concerta for the last 2 school years and this year he started out fine in October and November he started acting weird, he was always scared even in the day time he wouldn’t be in a room by himself and was always hearing things and seeing things and his Pediatrician told me to take him off for the holidays and it made a world of difference, he is still afraid to sleep alone but he is functioning like a normal 9 year old. He is now on Intuniv and all it does is make him tired he has only been on it for 3 days so Im hoping it will eventually work for him. He has been home sick this week and when Im helping him with makeup work he gets very depressed and says that he is stupid cause he can’t concentrate…
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I’m wondering if maybe there was something different in the generic brand concerta that made him feel paranoid.
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> Hi thanks for your quick response and no nothing changed in November other
> than him having to get rid of his puppy due to allergies. His pediatrician
> had put him on Periactin to help with his appetite but I’m not sure if that
> had anything to do with it. It was really scary to see him like that, he’s
> never been a fan of the dark but this time he was seeing someone jump on my
> porch at 3:00 am with the curtain closed, he was hearing screams in the
> night and wouldn’t even go to the bathroom alone during the day, woldn’t go
> to his room to play video games or watch tv, he stayed right next to me at
> all times. I am really thinking that I need to take take him to a
> neaurologist and have him tested and stuff, I don’t want to keep trying new
> meds. Thank you so much for your input and advise… -
Hi Gina well yes I got the book and it is very interesting, but I have to read sentences over and over cause I have ADD and I just can’t comprehend what Im reading and not to mention I think of other things when Im reading…LOL…Due to no medical insurance I don’t take any meds for it, but I do take zoloft 200mg for depression….
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I realize this is sort of an old post, but thought I would chime in in case someone (like me) is looking for info on generic Concerta. My 9 year old has been on Concerta for several years. We switched him to generic Concerta in June and I didn’t notice any change. Looking back now, I think this is because he was out of school and his days were just composed of fun activities and free time and he didn’t really have a lot of opportunities to get frustrated over work.
When school started, we put him in a private school that specializes in kids with learning differences. At first we thought he was just taking a while to adjust to a new school, but his behaviors only increased in severity. He refused to do any work, would run out of the classroom, screaming/crying/fits, and eventually started attacking the other kids. He was asked to leave the school in November. I home schooled him for a month while I worked with our local elementary school to get his services back in place. He has been in this school since he was 3 and we’ve had a great team of aides and support people. Right before Christmas, he started going to school for just half of the day. We all agreed that since his behaviors had been so much more intense than they were in the past, that a half day was probably all he could manage.
The team at the school has been documenting every outburst/whine/tantrum and keeping a detailed spreadsheet. We have probably 4-5 weeks worth of sheets now and every day he has an average of about 10-12 behaviors that require the team’s attention. (in four hours) He spends a lot of time by himself in the resource room, by choice.
Last week, a friend gave me her son’s leftover name-brand Concerta that he was not going to take and it was the same dosage as normal for my son. (Yes, I know this is probably frowned upon, but we do what we can to save money.) He took the first one on Saturday. On Monday and again today (Tuesday) at school, he stayed in the regular classroom the entire time and did not have a SINGLE issue. This is a child who at times has three adults with him at school to help manage his behaviors and he made it through two days without a single whine, cry, anything. His team was amazed and asked about any changes in his routine. The ONLY thing different has been the name-brand Concerta. I realize that 2 days is not enough time to establish that this is a definite behavior change that can be attributed to switching meds, but after having every day at school be a disaster since August, getting kicked out of a school that specializes in helping kids like him, and reducing the length of his school day by 50%, this is truly miraculous for him.
I’m sticking with name-brand and hoping that my gut instinct is correct. I had just brought up the possibility of the generic Concerta being part of the problem with his psychiatrist last week. She said that it “wouldn’t be unusual” and wrote a new script to be name brand. Hoping that when our freebie pills run out, our insurance will let us get the name brand again without too much of a hassle.
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Yes, the medication contained within each pill is exactly the same for the Concerta and the Generic. The DIFFERENCE is the time release coating/structure of the pill. This is the part of the medication that is under patent and cannot be copied by the Generic. This is what causes the drastic differences in the effects of the Concerta and it’s Generic. So those of you parents that are seeing the drastic change in your child… Name brand Concerta has a wax coat that has 22% of the medication contained in it and a hole is placed on the end by a laser to create an osmotic effect (water enters through the hole and releases the medication in a stable, balanced fashion). Because the generic is not designed in the same fashion, it releases differently and thus the difference in effect.
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My 8 year old duaghter’s teacher informed me that her behavior had turned defiant again, like before her concerta, and wanted to know if she had been forgetting to take it. After looking into it, I realized the last refill had been generic. I found out that, yes, the medicine may be the same in Concerta and the generic but the capsule is made different which causes different delivery amounts and times. Something as small as this made a big difference in my daughter’s behavior.
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No, Ky. From what I’ve read the concerta capsule and generic capsule are not the same, even if medicine inside are the same. This difference in capsules effects how the medicine is delivered into the child’s system.
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The months of June and July were causing me to think to myself, “What is wrong with me?” In August I noticed on the Concerta bottle it was GENERIC!! No one told me. The pills are no different. What I went through to get the med changed to name brand was unbelievable. I don’t think anyone believed me that there was such a big difference. Finally in September, I took my first brand name Concerta. I thought it might take a few days to notice the difference. Then the same morning I took the correct pill it dawned on me, “I am doing more and feeling much sharper.” Who would have thought? I was on my way back to being productive and useful again. I might add the reason for taking Concerta is a TBI. I was going merrily on my way then….I had the script refilled. Sunday morning was the first time. I thought this day is a loss because I can’t get anything accomplished and am so tired. Oh well, it’s just one of those days I decided. But it wasn’t! The next day was worse and the next day even more so. I grabbed the bottle to see if it was generic. It wasn’t. This has gone on for a month feeling that I’m feeling like a dud, can’t think things through and so so tired. It’s odd this started when I started a new bottle of Concerta. What I would like to know is how can I tell if I am getting the brand name. They look exactly alike and who would ever know which is which? Also, it would be so easy to get them mixed up at the pharmacy. The pharmacy I called was a bit touchy that I would even think I was getting the generic instead of name brand. She came right out and said “They are not switching one for the other on me.” Yikes. They have assured me the brand name and generic are exactly the same. They are wrong. I’m the one taking the pills not them. There is a big difference. After a month of despair about this, I have analyzed everything I do, everything I eat, everyone I talk to and everything I do. Everything points back to the day I took one pill from the new bottle of brand name Concerta. What is your opinion of the sudden change and also of the difference between the brand name and generic.
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Ian having the EXACT Same problem. My doctor the wrote for brand name only and last night when I filled my prescription they gave us the generic. Brougght it back, they said they switched the pills to the brand name but now in not sure. Took my morning dose today and feel anxious, almost speedy. Called the pharmacy back today and asked them if they have Concerta 36 mg in stock. They stated no they only have generic, they would have to order them. At 7 pm last night(2 minutes after closing time) they supposedly replaced our generic with name brand but after being open for 1 hour this morning they have no brand name? Something is Definitely fishy. I understand why the pharmacy insists they are the same pill, but my daughter and I take them and we both independently feel anxiety and headache and irritation after taking them. This is NOT in our heads. I am a nurse and have been on this medicine for years.
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I’ve been taking Concerta 54 (USA) for 10+ years with great success, until the generic came out. I’m usually happy to take generics because I can’t tell any difference, but not so with Concerta. I don’t care what they claim, generic Concerta is NOT the same. It’s not only weaker, but wears off much sooner. It should last 16 hrs but after 8 hrs it feels like I haven’t taken anything at all. This is not my imagination. I didn’t even know I was getting generic, or even that there WAS a generic, when I started noticing a difference. (My ins requires substituting generic if available).
To those who insist it’s made by the same manufacturer as brand-name Concerta, ergo exactly the same: that’s only in theory. Think about this: If the same company is making thier own product AND their competitor’s product, might they not have a vested interest in NOT making their competitor’s product quite as good as their own, whether “accidentally on purpose” or not? It’s an absurd business arrangement, come to think of it. Technically they may follow the same procedures and use the same formulation, but probably cut corners by using cheaper, lower-quality ingredients, looser quality control, lower-skilled workers etc etc.
Whatever the reason (and I’m sure we’ll find out – eventually), nothing will convince me that they are identical.
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Thanks, Gina, for believing me! – I’m in the US, btw.
I agree it doesn’t seem logical. Maybe only some of them are bad. Maybe a bunch got overheated sitting on a loading dock in the sun … something accidental like that. All I know is, what I got isn’t working. So for now I’m having my Dr write the Rx so I don’t get the generic any more (tho my co-pay will more than double)
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I, too, had a bad experience the first time I tried the identical generic. I went back on the name brand and it worked again. That was last summer. Now, due to the fact that I forgot to specify, I am taking the generic again, with no apparent difference in effect (and at a much lower copay, I might add).
Could it be there is a QUALITY CONTROL problem with the Watson version? We have pretty much established they are the same drug, made on the same production line, with the same markings. So maybe the problem is with quality control during the Watson production runs, or with handling or temperature or humidity post-production?
This is the only theory I can come up with that would explain the apparently random and occasional differences between the two sources.
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Yes I am in the USA and this is the case in the USA…
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I just wanted to chime in on this, I was web surfing about this and found you all.
I noticed I had received the generic’s about a couple months back at Walgreen’s when my script copay dropped in price from like 30 to 5 dollars. I asked if they made a mistake, and they replied no, so I let it slide figured they made a mistake in my favor. Later I did notice on the bottle it was not Concerta anymore this concerned me, after all this stuff does who knows what exactly??… and it does it in the brain! I don’t want any mess ups in there so I had compared to some older pills I had in the cabinet, and they looked identical but, I did notice it was not working as well. So on my next refill I requested Concerta instead of the generic, and I definitely noticed a difference. It did cost more but in my opinion they are different. If you have any doubts try switching back and see if you have the same results.
It was funny when I requested the non generic Walgreen’s took like a week to get order filled.
I live in the US near Chicago
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My 7-year old son was diagnosed with Inattentive ADD a little while back, maybe in September. He has been on Concerta since about week after his diagnosis – the first med caused heart palpitations. He is now on 27mg Concerta. Recently, we went back to the psychologist for further testing (learning disabilties) and the psychologist told me that my son should NOT take the generic form of Concerta, that is an inferior product. (We are in California). He went on to say that the FDA does not set standards for generic medications like they do for the brand name medications, and that the generic form is substandard. We started my son out on Concerta, but then I read the generic was the same med so for the past few months I filled the Rx with the generic.
That was a mistake. My son stops focusing about 8 hours in instead of the duration he was able to focus on the Concerta. My proof was that in his after-school martial arts class he had been able to focus, but on the generic he was not able to focus because that is later in the day.
I just filled his Rx today and have a few of the generics left. I cannot tell one iota of difference in them in a side-by-side comparison, but I see the differences in my son when he takes both types.
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Thanks so much for all of this voluminous information. My son was just diagnosed with ADHD (he is 8) and I live in USA. Just filled his first script for Concerta (18mg), and they gave me the generic. He’s been on it for only two days, and his impulsiveness seems to have decreased, however, his teacher still needs to redirect constantly. I’m hoping that with increased dosage (as his doctor suggested might be necessary after a trial period), we will have his issues under control, but after reading all of these posts, I may bite the bullet when his next script is due and pay the $120 for the brand name.
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Hi Deb,
It took my son months to acclimate himself to ritalin/concerta. His brain needed to adjust to the drug. Now, for him, what a help it’s been! Give it a little time before changing it around. And good luck! Incidentally, my son now uses generic and doesn’t feel a difference.
Best, Beverly
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I bought the generic concerta a couple days ago because I have no insurance and the “real” would have cost $265 (36mg, 30 pills). So far I hate the effects I am feeling! I can’t focus or remember a thing! My brain is racing (opposite of real concerta!) so bad I’m combining words,can’t finish a sentence or grasp a thought! Physically I feel uncomfortably wired and my ears are ringing. Anybody else have this happen to them? Right now I wish I paid the extra $85 for Concerta. I can’t imagine taking this stuff for a month!!!
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Hi Gina,
I my child is 21 now, and I find myself without coverage for his meds, which for asthma and ADD are expensive! I just had to pay $185.00 at CVS, in L.A., California for generic Concerta (Methylphenidate ER 36). All this year, each month we’ve been paying more and more for his prescription. I wish I could find the sort of savings you write of. Any source suggestions would be VERY appreciated.
Thanks!
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I just switched back to Concerta fom the generic and did notice a difference in the Alza stamp size and the pill shape. The ends of the pill are not exactly the same so how can the generic be the same exact pill as the branded one if the stamp looks different and the shape is slightly different. I will keep you posted as to whether I notice a difference over the next two weeks. I just know that I felt great until about six months ago and that is when I was switched to the generic. I live in the U.S.
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Stumbled across this board and thought I’d throw my two cents in. I’m in my forties and have been using Ritalin and/or Concerta for over ten years. I live in the US. Last summer, I noticed that the Concerta wasn’t working. I was hesitant to up the dosage and my MD advised that that I’d been using generics. I switched to Focalin with limited success and then back to Concerta – non-generic. The difference was immediate and noticeable. Now, unfortunately, I was given a generic brand again and, while I notice from above that there shouldn’t be any difference, I can’t help but notice that the drug isn’t working as well as it has when using the non-generics.
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Okay….I have taken concerta for several years I was off of it for the past year bc I was pregnant, etc…. when I filled my first scrip my copay had gone to $60.00….UGH!!!! So I talked w my pharmacist, who informed me that there was a “generic,” but my Dr would have to write a new scrip by that exact name, because…..the FDA does NOT recognize the “generic” as a generic so the pharmacies CANNOT fill a concerta scrip w the methylph…..whatever it is. Make sense?? So, the I paid my $60 and went on, the next two months I requested the generic from my Dr….went to my usual Target pharmacy, they weren’t stocking it???? So I drove to CVS, got it no prob, looked exactly the same….but only cost $30, I thought they screwed up, same thing the next month….then about two weeks ago I started to realize that I was so off task, not finishing things, remembering things, being impulsive w all kinds of things…..so I mentioned to my Dr, reminded her I have a 3 yr old and a newborn….maybe that’s it, she laughed and said let’s go back to the concerta…so ibid, headed to Target, discussed my feelings w the pharmacist again…..and she totally confirmed that the methylphenidate or whatever is NOT a generic.for concerta, the FDA has not Approved it…..hence why i cant fill my concerta scrip w the generic, its NOT a generic. Anywho….I have my $60 scrip and hope it works like it should…
And I’m in the US….so confusing, but I will say they are NOT the same, wish they were….. -
My 6 year old son has been on the Daytrana patch 15 mg for the past 9 months and it has worked great for him in school. However it’s been starting to get really hot here in Mississippi and the patch delivers more of the meds when it’s hot, and he’s been absolutely a zomby when trying to play baseball and this is 2 hours after removal of the patch. So his dr has changed him to Concerta 18 mg, which he started today, and I really can’t tell he’s even on meds now. His dr didn’t mark generic or namebrand when he wrote the prescription, but did explain to me that his reasoning for choosing Concerta was because of the advanced delivery system it has. The pharmacy have us the generic, and now after reading today, I’m wondering if this wonderful delivery system isn’t the same in the generic. Not sure what I should do. Wait, try to exchange at pharmacy (IF even a possiblity), or what. Any suggestions?
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I have been requesting the generic concerta since it became available for my son in 2011. So far, nothing has changed, still the same positive results. The only that has changed this year: the cost. $157 for the generic. I realize this is because of our insurance, but this is the full cost we are having to pay since we no longer are able to have copays allowed (we have to reach a high deductible). At this point, I am considering stopping it. It has been the script that has worked the very best, but at $157 a month, more than $5.20/pill, along with another $150 every 3 months for a med check, I just don’t know if we can afford it anymore. That’s the cost of a high end coffee that I also stopped buying years ago because I couldn’t afford it.
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I just googled and found goodrx.com/concerta wow! I am really feeling deflated right now about the cost of this medication. I’m thinking that concerta must be in high demand for that price for a generic.
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Hello Gina and everyone. I’m chiming in on behalf of the pharmacists out there. Just a little background on me, I live and work in Florida at a Walgreens pharmacy. I’ve been in the profession for 8 years now and have a large base of ADHD patient and we keep a large stock of every one in for a large population. After reading all of the posts here, I am sorry that everyone has experienced the problems they have put in here. I’m going to give a little bit more information that may help some people though some others may not accept it. The first thing is about the markings and the tablets found in the US. When a generic medication is approved by the FDA for distribution, if it is not made with the same exact process and ingredients, the manufacturers are required to change the markings on it and often the shape or colors are also changed. This is to signify who the manufacturer of it is for identification purposes. If they change one iota of the process or they change one ingredient such as a binder or filler or anything else, this holds true. Therefore, the medication that is being dispensed as the generic Concerta is in fact the brand because it looks exactly the same (assuming there aren’t any counterfit medications going around) and has the same exact markings. Now, to say that there is less medication in there or that it is being changed for the generic, every company has to follow strict quality control procedures and medications are a lot stricter than other types of manufacturing facility. The batches are all numbered and they have to give consistent results otherwise, we would get a notification of a recall due to whatever the problem was that they found. So, I do not believe that there are any problems with the generic medications before they get to the watson plant for packaging. That brings us to the bioequivelance part. For a generic to be approved, it has to expose the body to 80-125% of the same medicaion compared to the brand (not other generics) as referred to by Gina earlier. This is calculated as the AUC or area under the curve. This means that as the body breaks it down, you can measure blood levels of it every hour until it reaches clinically insignificant levels. Add all those levels up for the brand and then multiply it by 80% and 125% to give you the range of what you need to see. The medication can give exactly the same curve, higher at times and shorter length of effect, or longer effect and lower curves or whatever combination that gets it within that range. For most medications, this isn’t significant like ciprofloxacin whose dosages are 250 and 500mg. But medications like synthroid that have very small increments, this can give a very significant response. But, that’s not a reason to not use the generic medications either. That just means that you usually have to go up to the next higher dosage or sometimes 2 higher to get the same result.
I do NOT claim to know all the laws in all other states, but florida does have what is called a negative formulary. On this formulary, medications that the generics do not show similar pharmacokineitcs are deemed to be NOT SUBSTITUTABLE based on the AB rating found in the orange book. Synthroid was on this list in the past, but has been removed. Some things on our list are conjugated estrogens and Extended release theophyline. There are 6 drugs on the list now for us, but other states can have these which would be possible as to why someone said their pharmacy told them that they needed the prescription wrote a certain way. Yes, Mail order is an effective way to get any of them cheaper for you if it is available. All mail order facilities have to comply with the laws of their state and the ones that they are distributing to. The controlled substance act (CSA) does not state an expiration date on any Schedule II medication or C-II medication, nor does it place limitations on the quantity that can be wrote for. Some states do put limitations on these, for example, in Florida, all C-II prescriptions expire one year after they are wrote. But all other prescriptions do that too, with the exception of C-III to V expire 6 months from the date that they’re wrote. So, your doctor could in theory write you one script for a years supply of the medication, but I doubt that anyone would fill it or an insurance company would pay for it. Good general practice guidlines would be that if it’s older than 3 months ago, contacting the doctor to see if it’s still appropriate and the current dosage should be done. Another thing that should be noted that people have commented about is that it is actually Illegal according to the DEA for a pharmacy to accept any controlled substance back from patients for ANY reason. I was at a conference that the DEA hosted and discussed this topic with us because there were many questions about it in March. Therefore, I always suggest before paying for your medications to ask to look at it and ask what it is and what it is for and if brand or generic was dispensed, etc. That way, you don’t get something incorrect and get stuck for a month without the medication. There was another commenter above that said something about getting methlyn ER and then being given Metadate CD instead one month. These are 2 very different formulations which should not have been interchanged unless the prescription states it. Methlyn ER is a tablet and Metadate CD is a capsule. This is not an acceptable interchange as they are different dosage forms and have some different pharmacokinetics and would have definitely seen a difference in effect. For that person, I’d suggest visiting that pharmacy and ask for a copy of the prescription. If it says a dosage form on it (like ER), I’d bring it up to the pharmacy manager and ask for a refund for a mistake that was made. Our policy is to make ammends for mistakes like that. We have an internal review process that protects us legally to errors because everyone can make a mistake, but as long as you learn from it, it shouldn’t happen again. Normally, we just refund your copayment so there would have been no cost to you, and even if there wasn’t a cost out of pocket, they need to know about the error so it doesn’t happen again.
And the last topic that I’d like to talk about is switching and the response to which one is taken. When any study is performed to evaluate the patient’s response to a medication, they do what is called a double blinded study. That means that neither the person taking the medication nor the person distributing the medication know which one they are receiving. This is done to make sure that there isn’t a bias involved in the effects. When you are taking it or are giving it to your child, you know what you’re giving them so you are always biased on the effects. Whether good or bad. I do understand that there is inter patient variation and not everyone responds the same way. But to say that the same tablet manufactured by the same company coming out of 2 different bottles that are labeled differently is along the lines of the placebo effect. Another example of this is when I have patients come in and say that claritin doesn’t work for them, but alivert does or motrin works, but they get no relief from advil. It’s the same medication with a different brand name (loratidine and ibuprofen respectively), so if one doesn’t work, the other one can’t either. That’s also like saying you don’t get any nutrients from a granny smith apple but you do from red delicious ones. Yeah, they may taste and look different, but getting nothing from one just won’t happen. This again is something that the FDA wouldn’t allow to happen through regulations and monitoring. If it’s made to go into one bottle, it’s the same stuff to go into another bottle.
I will say that I am open to all criticism and questions. I do have an open mind for most things, but with all of the regulations the FDA has in effect and the quality control measures in place to prevent changes to the formulation and process for the drug to be made and then distributed by the 2 different companies, I don’t think my view on the fact that there isn’t a difference in effectiveness will change.
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For what it’s worth, my doctor, who is a bit anal about “details”, also told me that the coating on Concerta is different than the generic. He talked about the holes drilled in the pill as well. The way he explained it to me is that the patent is for the coating. The coating has short-release ritalin which kicks in immediately; once the coating is dissolved, the inner part of the capsule starts taking effect. My doc said the manufacturer did that because it takes about 45 minutes for the drug itself to kick in. The coating was added to get more of an immediate effect. The patent also differs in terms of time-release. Same drug but the patent is for the time-release. So yes, a generic version will time-release differently.
When I took generic ritalin, it felt like a sudden “burst”, then it would level out and I would “crash” when the medication was starting to wear off. 2nd dose during the day, same thing.
I have taken concerta for over 10 years and it has been exceptional for me. My pharmacist changed it over the generic concerta about a year ago and I absolutely can tell a difference. Not necessarily bad but it does not feel AS effective as Concerta. Concerta was solid in terms of time release and it feels like the generic wears off much sooner. That has just been my experience but I know there are differences. I think it doesn’t effect some people and some people it does.
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1) As a 42 year old diagnosed with ADHD in my mid-30′s, my experience is that the efficacy of the generic is virtually identical to that of the brand name. The only difference I’ve noted is that the side effects seem to have hit me a little differently and it may not last quite as long through the day.
2) If a pharmicist tells you there is no approved generic for Concerta, go to the next pharmacy down the street. I was given the brand name at a big box store. When they charged me $45 (vs. $0 for the generic), I was told that there was no FDA approved generic for Concerta. The next day I drop my prescription off at another location of the same chain and get it filled with a generic.
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My daughter was on name brand Concerta for 10 years. The first day she was on the generic Concerta I noticed that she was cranky in the afternoon. During the past few months of daily generic Concerta, her anxiety level grew, and she has had angry outbursts, always in the evenings. It was like switching on a lightbulb, how quickly she became upset or angry. I asked her doctor if it could be the generic Concerta as the cause. He assured me that the two drugs were the same. After a particularly bad evening last month, I contacted him, and although he did not think it would make a difference, he agreed that she should go off of Concerta completely. Since then, she is calm, and it has been three weeks now, with no anxiety or angry outbursts. Reading this blog suggests to me that some people, like my daughter, are sensitive to some type of change in this drug when it became generic.
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We are going to discuss her options with her doctor in the next two weeks. Right now, she remains off of the med, and is doing well.
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I have been on concerta (generic) 36 for about 7 months and felt it working. I needed to increase my pill due to new changes in my life and started Concerta (generic) 54, this is the first month but I can not feel anything. Is it unusal that I can feel the 36 work right away and not even feel the 54?
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I have a question… as an uninsured parent, my family has been paying full price for my son’s Concerta 36 mg cr tablets. Obviously as being uninsured it means that my family cannot afford ‘family health coverage’ which would be over $1100 a month.
So… my question is simply this. Where/what is the best resource for getting the “U.S. generic for Concerta methylphenidate hydrochloride extended-release tablets”? We’ve been going to Costco pharmacy and every month the cost goes up and the non-generic has been $180 for each 30 days supply ($540 for 90 days supply). My son needs these meds to be academically successful in school, but we can’t seem to get any local pharmacy to be forthcoming with anything other than name brand Concerta.
My son’s Dr just rewrote a 90 day prescription for Concerta 36 mg and then told us to shop around and that a generic should be available for about $60.
Where do I start? Calling random local pharmacies or some online mail-order site or what?
I want’ my son to be successful, but not at the cost of not eating meals.
-Bill
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g.
Thanks for your timely reply.
1) Family Health Care: We’ve not been eligible for coverage through work as my wife’s company only has 2 employee’s (boss and her) and the cost’s for a 2 employee company are too high. I work 2 part time jobs. A local public school and a bus company. The bus company only has coverage for me if I pay 100% of it and the school’s ‘family coverage’ would be $1100 per month, which is more than I make as a part time employee. So I’d end up paying the school district to permit me to be an employee if I went with their program. As for government assistance, since my wife and I both work and make ‘Too Much’, thus far we’ve not ‘qualified for any government health aid program. I too had opted to have health care insurance be coverage for catastrophic illness, not routine doctor visits. Hence we’ve paid out of pocket for the last 6 years all our health care costs. In the end, compared to the other ‘health care’ options we have we’ve copme out on the paying end. However, my son’s meds costs are crazy. If people who have insurance realized the ‘real costs’ they were paying there would be a revolution in the streets. Yet everything is masked by 3rd party payment systems. I’m a sceptic about the newest program … ACA. I’ll only believe in real change when I see it in my pocketbook.
2) Concerta at less $: I found a coupon program at ‘GoodRx’ site for $78.73 at a local pharmacy (not Costco). I’ll call the direct numbers you listed for Watson. I’ll also check if Costco has the mail order program. My son’s Dr wrote three prescriptions each for 30 days for the next consecutive 90 day period. We’ll also check your other recommendations for the manufacturer’s $ assistance program as well as the pharmaceutical clearinghouse for financial-assistance programs too. As well as CONCERTA® phone number being 1-800-JANSSEN.
I’ll update you on our results.
Thanks
-Bill -
My insurance will change in January 2013 to a straight 20% coinsurance for all covered expenses including drugs. We’ve been used to pharmacy by mail co-pays for 15+ years. I am taking Methylphenidate ER 36 mg 24 hr Tab (Concerta generic) and we currently pay a $10 co-pay for 180 pills which is a 90-day supply. My husband called the pharmacy to check on the actual cost for my 90-day supply and we were completely shocked to be told that it will cost us $908.00 for 180 pills. How can this be a generic? Why on earth would the cost be so high? Mind you, I’m not taking Concerta, I’m taking the GENERIC drug!
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My son was on the name brand Concerta for a few years and just recently switched to the generic (US-California). I could definitely tell a difference! He is was so sensitive and just wasn’t himself anymore :/ I couldn’t joke with him or play…he took everything so serious. All he wanted to do was play video games or watch TV. He was not like this before the generic came out. I argued and argued with the pharmacist who assured me it was the same. I eventually took him off of it and hes going un-medicated right now. But guess what….? I have my boy back…he jokes around and plays like a normal kid
He is having trouble in class and I’m really working with him at home to make up for that. We may have to eventually home school him, I’m not for sure. I just wanted to “side” with the other parents on here, there is a difference. -
It is so interesting to read these posts as I have been on the generic Concerta go round for six months. My 14 year old daughter had no idea she changed to generic but her behavior was similar to many others, added anxiety, evening outbursts, etc. I switched a few times and even tried a new drug, but to no avail. So we are going back on Concerta non generic to a tune of $167.00 a month. I know this is still a good deal, but my co-pay used to be $25.00. Hard pill to swallow, so I wouldn’t be doing it if it wasn’t essential…
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My son has been on brand name Concerta for over two years (manufactured by Jenssen Pharm). His focus improved tremendously as did his grades. We are very happy with the product. In the last month my son has been telling me it isn’t working any longer. He is unable to focus and his mind wanders. It recently dawned on me that the only change in his life has been the switch from Concerta to generic Concerta (manufactured by Watson Labs) – no change in dosage. He is now back on Concerta, no longer using the generic version and his ability to focus has returned. I myself have taken generic versions of medications in the past with no problem so never thought twice about putting him on generic when the pharmacist asked if that would be okay. I assumed the generic would work exactly as Concerta had. I am at a loss to explain, but it appears the generic form is ineffective for my son, which is very unfortunate as Concerta is quite costly by comparison.



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