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What’s Up With Generic Concerta?

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You can read updated details about generic Concerta in this 12/12/13 post; please subscribe to this blog to stay apprised of developments.

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?  Yes, according to this FTC report on generic drugs, it is 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 through 2014.

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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  1. Ryan Stewart’s avatar

    Hello,

    I I’m glad to see that this thread appears to still be active. Hopefully, I can get some useful information from here. I am a grad student, and have been on Concerta for a very long time. After trying many different brands and doses, somewhere around 5th or 6th grade (I think, it’s been a while), I was started on two 54mg Concerta capsules every day. This worked significantly better than other brands and doses. I have been on the exact same dosage since then (~12-13 years). A few years ago I switched to the generic. It looked the same and I didn’t really notice a difference. I had been warned by my doctor to avoid the generics, because there were various problems with them.

    Today, I went to pick up my medicine from the pharmacy as usual. On my way back to campus (I was home for the weekend) I noticed that the pills looked different. At first I was concerned that they might have made a mistake as both would be described almost the same way. I was wondering if anyone had any experience with the Kremers Urban generic Concerta. Not much of a difference at first, but I feel more jittery than I used to, and I’m finding myself more distracted. (I’m here instead of studying for my last final) I wouldn’t have minded trying a different manufacturer over the break, but a trial by fire in the middle of finals was not something I wanted.

    If I remember to, I will update in a couple of days when I get back home. Maybe I’ll be able to give a better analysis when I don’t have papers and finals causing their own interfering signals.

    Thank you,
    -Ryan

    Reply

    1. Ryan Stewart’s avatar

      Sorry to reply to my own post. I am in the US.
      And I also apologize for not proofing before I posted. Error in the first word=not a good start.

    2. Gina Pera’s avatar

      No grades on blog comments OR posts, lucky for both of us! :-)

    3. Gina Pera’s avatar

      Ryan, I’m sorry to hear this. And what lousy timing. It just shocks me that pharmacies are allowed to do this, without any warning to the consumer.

      Yes, I have updated this information with a more recent post:

      http://adhdrollercoaster.org/the-basics/a-recap-consumers-guide-to-generic-concerta/#.Uq-2kI1UjZo

      Good luck on the finals!
      g

    4. Rose’s avatar

      Ryan ……I just picked up mine yesterday…..they are pink and look totally different than the old white generic version which used to look exactly like the brand name ones. At first I did some research and found out that this is NOT the same company that used to manufacture the original generic concerta….which I have used and had no problems with. This new and very cheap version (obamacare fallout) is NOT the same drug. It is crushable and does not have the same delivery system. I am prescribed two 36mgs in the morning which normally would last all day or 7 hours max…..not now….I am unfocused after 3 hours and feel as if I am taking an IR form of Ritalin now…. which is fact it basically is…..

      Next time BEFORE you refill ask for BRAND NAME. My insurance has a much higher deductible now(thanks again obamacare)…..this is a another way the insurance companies are trying to cut costs. This is a VERY dangerous practice and these companies are going to regret doing this…..

    5. Gina Pera’s avatar

      I would not be so quick to blame Obamacare, Rose, for your troubles.

      Has it occurred to you that many companies are using Obamacare as a pretext to raise prices (as they have annually for decades, before Obamacare) and have people blame it on Obamacare (aka, better regulation of an out-of-control healthcare and insurance industry)?

      If you want to support better consumer protection, you will think about blaming poor regulation in these issues.

      Clear thinking is required on this topic and many others.

    6. Tom’s avatar

      Same thing. I had to go back to my doctor and get at new script and junk the rest of the Kremer Meers medicine. Kremer Meers should not be allowed to qualify as a substitute for Concerta. The difference in effect is compelling enough to make me question how this drug made it through testing as a qualifying substitute for Concerta. Don’t be afraid to tell your doctor. You should not be penalized for the FDA’s screw up on this. I was able to get my usual script and was able to work with my insurance to minimize the cost of the Brand name I replaced the Kremer Meers garbage with.

    7. Gina Pera’s avatar

      Hi Tom,

      Congrats for being a smart consumer.

      Please consider filing a complaint at the FDA’s MedWatch. This is the ONLY way to change this situation:

      https://www.accessdata.fda.gov/scripts/medwatch/

      I will devote a post solely to the Medwatch form soon. Lest it be lost in all the other details.

      Best,
      Gina Pera

    8. Heather’s avatar

      So glad to have found all of these experiences. My son is 13 with ADHD. When we picked up the generic Concerta a few days ago, he noticed that it looked different from the previous generic. I checked the bottle and decided that they must have switched manufacturers but told him to go ahead and take it. With the Kremers pill, he is having problems with black spots in his vision, dizziness, headaches, & numbness in his fingers.
      Thankfully, our doctor is great and told us to discontinue for a few days to ensure the reaction goes away and can for sure be linked to the Kremers generic. After that, she will make sure that we only get the brand name and will write the insurance if needed.

      It’s amazing to me that pharmaceutical companies can get away with subpar work such as this.

    9. Gina Pera’s avatar

      Hi Heather,

      I congratulate your son on his attention to this important detail. :-)

      Yes, the generic manufacturers are a different breed, compared to the major brand manufacturers. They come in with these inferior products (for ADHD, at any rate) and make them so cheaply the drugstores are lured to the greater profits.

      So much for caring for the consumer. Then again, consumers must be smart and vigilant, not passive.

      Best,
      Gina

    10. Ann’s avatar

      Ryan,
      Thank you for your comment. My son has also been on a dosage of 2 36mg Concerta tablets daily for over a decade without incident. In December he got the Kremers Urban generic and for 4 straight days had a dizzy-headache effect at the 4 hour mark. He stopped taking the drug, return to the pharmacy, notified his doctor, and reported the adverse effect to Kremers Urban and to the FDA. It is only through reporting these issues to the FDA that a database on the issue can be maintained and the manufacturer is forced to dig deeper into the performance of his product. My son has returned to using only Concerta which for him ends up being $490/month. Thank you for telling your story. I suspect that you two are not alone.

    11. Rebecca’s avatar

      I had the same thing happen to me. I was concerned but decided to see what happened if I took this generic instead. I noticed a marked increase in my impulsivity and my tolerance for stimulation lowered dramatically. I am a teacher and it really started to cause problems for me, especially in the afternoon. It seemed to wear off more quickly. After research, I found one post that says your doctor has to put OROS on the scrip which is the patented time release system used by the people that make Alza. My doctor was no help. She simply put time released and all the pharmacies told me all generics were time released. I explained yes but not in the same way. They weren’t interested and acted like their hands were tied with the statement they have to prescribe whatever is sent by corporate. I did find a local pharmacy that still has alza and switched there but they too said that they aren’t sure how long they will keep this type of generic. One thing I started to do was to wait until lunch to take my medicine. This allowed the medicine to start kicking in during the most stressful part of my day. Good luck with this very frustrating change! :(

      Reply

      1. Gina Pera’s avatar

        Hi Rebecca,

        Thanks for sharing your experience. I hope you will report the problems you found with this generic at the FDA’s Medwatch website. I provide the link at the end of this recap of the best current information on these generics of Concerta:

        http://adhdrollercoaster.org/the-basics/a-recap-consumers-guide-to-generic-concerta/#.Ur3IAfZUjZo

        You probably the suggestion about having the MD write “OROS” on the script on my blog. I’ve written that advice in several blog posts since this original one.

        Your doctor doesn’t know her stuff, obviously. If she would not write OROS, then she is ignorant. Period. I understand if you don’t want to change doctors, or there’s not a better option. But I will just tell you, that is embarrassingly ignorant of that MD. Shame on her.

        Good luck!
        g

      2. Rose’s avatar

        ugh…….looks like my Concerta is going to cost a whole lot more…..thanks OBAMACARE…..what a mess this is making of our healthcare !!!EVEN with insurance I don’t HAVE insurance anymore.

      3. Gina Pera’s avatar

        Rose,

        These generics were LONG into play before Obamacare was even passed.

        If you want to look for scapegoats, look to purely-profit-driven companies who want to foist inferior products on you. Look to greedy politicians who are bought and sold by entire industries to subvert government institutions that are meant to protect us.

        Even stores such as CVS have much to gain by selling these generics, because they make more profit on them than they do in selling brand or the authorized generic. These stores are making choices about the quality of product their customers are receiving. Trouble is, customers in many areas have very little choice.

      4. Marcus’s avatar

        Gina and Rose both, in this case it’s not about Obamacare or “greedy companies”. Both statements are rather offensive and take the focus off the real issue:

        It’s the FDA deciding that a non-OROS generic from companies like Kremers Urban is bio-equivalent to Concerta. That’s the crux of it.

        Anecdotal evidence, including my own experience, shows that they’re not equivalent, and all anyone can do at the moment is hunt for the Watson generic (try Wal-Mart, as of today they still distribute it as confirmed by a Watson rep) and log a complaint with MedWatch.

        Reply

        1. Gina Pera’s avatar

          Thanks, Marcus. In fact, I think it is greedy companies. We know how public policy is over-influenced by lobbyists, and it’s hard to believe that’s not happening with the FDA as well in the case of these generics. I suspect that scientists at the FDA are as upset about these problematic generics as the rest of us.

          I interviewed a patent attorney on this topic the other day, because some reading on the topic was leading me to question if in fact Mallinckrodt overstepped some legal boundaries. This attorney said, “No, actually, they’ve been very wise in how they took advantage of opportunities.”

          “Wise,” he said. I said that in my opinion, it was not wise but socipathic to turn people’s lives upside down in the interest or profits. This attorney had no clue; he has completely bought the line of bioequivalence.

          And I believe we can do more than what I’ve suggested thus far: Ask the MD to write “OROS only” on the script and log a complaint with MedWatch. We can complain to our representatives in Congress, and we can pay attention to political campaigns.

        2. Marcus’s avatar

          You raise a fair point: if FDA scientists are able to show, and have reported, that non-OROS generics are not as effective as OROS, there must be some sort of undue influence hiding the science, incompetence in the FDA, or some other reason. If so, then it’s quite possible that lobbyists are at least partly responsible.

          However, your comments seem to make it feel as though there were some “dirty” CEOs conspiring together in a dark room plotting the doom of every patient. I doubt this is the case. No doubt companies like Kremers Urban are looking at the huge opportunity for a generic Concerta and coming up with a formula and delivery system that fits the FDA requirements. They’re just trying to make a profit (as a public company) and are under regulatory guidance. Luckily for us in the USA we’re talking about delivery effectiveness, not the fact that the drug is actually methlyphenidate or something else (like talcum powder) as you might find in China.

          If the law is faulty, however, such as using terms like “bio-equivalence” when that means 80-125% the same as the original when plotted on a chart, then it’s not strictly the company’s fault who produces medicine that fits the profile. Unfortunately for those with ADHD, having a “bio-equivalent” drug may not be good enough, even though it may be fine for some other drugs, like an antibiotic.
          Perhaps there needs to be rules that for drugs with unique delivery systems such as Concerta it’s not a generic until and unless the delivery system is matched. After all, Concerta isn’t Concerta without OROS – it’s just methylphenidate otherwise.

          I would also add one other step that people can take. If the generics don’t work as well (or at all), ensure you tell everyone about it – the pharmacist, the drug company, the distributor, people at the doctor’s office, and so on. And, of course, write “OROS only” and log a complaint with MedWatch. Won’t argue with you there.

          Reply

          1. Gina Pera’s avatar

            It’s not the FDA scientists’ job to do that (show that non-OROS are not as effective). Their job is to make sure all regulations are followed.

            As far as telling the pharmacist, etc. that’s all well and good, but many pharmacists don’t understand the problems with some “bioquivalence.” Smart MDs understand, but some will argue with you.

            You know how laws are….there’s always some clever legal mind that exploits the language and loopholes.

            Call it what you like, I find it unconscionable to make money from people’s misery.

            As far as alternatives, that’s the point: MANY people no longer have the alternative of getting the OROS. Their insurance companies and pharmacies will not carry it, because the “true” generics are cheaper.
            g

          2. Marcus’s avatar

            I hear you, and feel other’s pain. My formulary no longer covers brand-name Concerta and we’re facing the same issue with the Kremers generic that many other people face. I’d bet, though, that there are others who aren’t as sensitive to the non-OROS generics. I can only hope that there are enough MedWatch reports logged that the FDA looks into it.

            It does bring up a question – if the drug companies are manufacturing in line with the regulations, and the FDA scientists only job is to compare dots on a chart to make sure it’s adhering to the regulations, how does anyone really determine if these regulations are appropriate and effective? I wouldn’t trust my Congressman or Senator to know, nor their staff. This will be hard to change, at least until OROS goes generic and perhaps the delivery systems improve.

            So like many others I’m spending time hunting for pharmacies that carry Watson or will have to pay over $200 out of pocket every month for a DAW script not covered by my plan. I’m lucky enough that I’m in an urban area where there are many pharmacies (big and small) in a 20 mile radius. I feel for those who are remote and have little choice.

          3. Gina Pera’s avatar

            Hi Marcus,

            My general understanding is that the guidelines have not kept up with the novel delivery systems (OROS, etc.).

            g

          4. Alicia’s avatar

            Thank you for posting/

            I thought I was given the wrong med. that is how I found your post. I thought I would do some research before going back to the pharmacy. The generic I was prescribed is exactly what is posted Lbir: Kremers Urban / Methylpenidate ER 54 MG Tab.

            I picked up my refill and today was the first time I took it. There is no point in taking this generic medicine it does not work. I will contact my doctor to see if there is an alternative.

            I will print out your website for him to check out, and to see others are having the same issues.

            Reply

            1. Gina Pera’s avatar

              Hi Alicia,

              I’m glad you found my blog, too!

              I would try to return that medication. Even if they won’t give you your money back, you can register that as a voice of protest.

              If the pharmacy knows they are going to be dealing with problems on an ongoing basis, they might think twice about not carrying the authorized generic.

              Good luck!
              Gina

            2. nancy’s avatar

              My daughter also noticed that the generic was not as effective as the brand name. I use the generic, but have a few of the brand name still left, for when I need to really concentrate. This past refill I asked the doctor to do a Brand Name Only Rx.

              Reply

            3. Mark T’s avatar

              Gina, I came across your site by accident while looking for Concerta price deals. I have recently been diagnosed with Adult ADHD and my insurance company has just refused to cover me because I’m over 25 years of age.
              I managed to get a 30 day trial and it changed my world. Now I’m left in a dilemma because my local pharmacy is asking $180 for 30 54 mg tablets. I just don’t have the extra cash to do this every month. I was interested to know were you got the 90 days supply for $120 and $20 for generic.
              Thanks in advance for your advise.

              Reply

              1. Gina Pera’s avatar

                HI Mark,

                Are you in the U.S.? That will make a difference as to insurance guidelines.

                The FDA has approved Concerta for adults, so the insurance company cannot use age to deny you.

                I would try to fight that restriction. Talk to customer support (for the insurance company) and explain your situation. Ask for your options or ways you can appeal this. There is almost always a way to appeal.

                It might be that the insurance company objects to the brand name, and wants you to take generic instead. Sometimes what happens is that you have to try the generic and report the adverse effects (if indeed they are adverse) and then you can get the brand.

                In other words, I wouldn’t take this lying down.

                But maybe I am misreading; you say “my insurance company has just refused to cover me because I’m over 25 years of age.” Do you mean you “aged out” of your parents’ policy?

                As for the 90 supply I wrote about, that is from my husband’s insurance coverage, with the Rx mail-order option.

                Gina

              2. Mark T’s avatar

                Hello Gina, Yes, I am in the USA. I live in Massachusetts and in this case I am the parent with the policy. In fact, Im 50 years old and have gone un-diagnosed until I read a very good article on a recent American Airways flight which defined every symptom I have had all of my life. I was tested and came in high. On checking today, because the denial is as recent as yesterday, I have discovered that it is my company who are refusing to cover ADHD medication for Adults over 25 and my insurance is simply doing as my company says.
                Im not sure how they can do this if the Government have approved it? As we live in MA, Im also told that I can not have more than 30 days on one prescription. Is this true?
                If I decide to pay myself, what is the cheapest option for me?

              3. Gina Pera’s avatar

                Hi Mark,

                I don’t know the applicable rules. It just doesn’t sound right that your employer can stipulate this restriction.

                My understanding is that the Affordable Care Act (Obamacare), among other reforms, prevents the insurance companies from discriminating against “mental” illness — as if the brain were not an organ and the most complex organ of all!

                I would think that, by state law, there should be some kind of information on that denial letter of how you can appeal this.

                Have you asked your prescribing physician?

                As for the 30-days prescription, yes, this is a standard limitation with prescriptions covered by insurance when filled at the local drugstore. But most policies offer a 90-day or 60-day supply by mail-order.

                As for cheaper options, you should check with the patience-assistance program for Concerta. Here is their customer service info:

                For more information, please call CONCERTA® toll-free.The CONCERTA® phone number is
                1-800-JANSSEN, and we are available from Monday through Friday, 9:00 am – 5:00 pm ET.

                Meanwhile, I would encourage you to read my book: http://www.amazon.com/dp/0981548709/tag=wwwginaperaco-20

                Sometimes the stimulant medications cause problems over time because most adults with ADHD have another condition, such as anxiety, depression, etc. Those conditions can be exacerbated by the stimulants. So, often there is a pairing of medications to treat both conditions (e.g. a stimulant and an antidepressant). My book covers in detail how to get better results from medication.

                Good luck!
                g

              4. Mark T’s avatar

                Thank you Gina, I feel reassured after reading your good guidance. Next stop Amazon.

                Regards,
                Mark.

              5. Gina Pera’s avatar

                You’re most welcome. Stand up for your rights! :-)

                g

              6. Jeff Kreines’s avatar

                I was delighted to get the Mallinkrodt generic because I saved $80 on my co-pay. Then I tried it. I was not looking for problems, but noticed a day in that the drug was not working as the Alza version did. Now I am working to get my pharmacist to switch his generics to the Watson version.

                Reply

                1. Barbara’s avatar

                  Thank to everyone who figured out there was a problem. January 2013 ish, after having never been on ADHD medication before (I am 46 yr Old female, just graduated college 2012 & now have a stumbling block in grad school), I was prescribed concerta and was given a generic, I’ve continued to have problems and concerns about my medication. Earlier in the year I received a letter from my insurance company they are re-evaluating if concerta will be a covered medication and would have a final answer in August. I called my Dr and he was going to switch me to Ritalin, I’ve been taking 2 36mg per day. I decided to wait to hear what my insurance company came back with before changing even though the cost for the prescription was very expensive. When it came time to refill, I called my insurance company and the cost was actually going to be significantly lower from before. The pharmacy said my insurance required only the name brand and does not permit or will not cover the generic.
                  I’ve just started the name brand and will see how it goes. I had gotten to the point I’ve been raising such a fuss over asking if I am on the right medications after so many medical problems my dr. did a DNA test. He said that rather then guessing and messing around with anything now the test will show what medications metabolize best in my system.
                  I’ve been relentless trying to figure out what’s been going on. Now finding out that it could have been because of a generic drug, I am hoping that things will get better in some way. I don’t think they could get any worse at this point.
                  Barbara

                2. Tiffany’s avatar

                  Hi all!

                  It is definitely not the same as the Concerta with the OROS release. 6 years I have used Concerta. I was prescribed the new generic and had to go back as well. 1. It hits you hard all early in the day and makes you gittery and then you hit a wall and it is like a caffeine high falling off a cliff. I get to 3 or 4 pm and could pass out and nap anywhere. And I am not a napper.

                  Ask your Dr. to make sure to not allow a subsititute and makw sure it is Alza with the dot on the side.

                  Good luck!

                  Reply

                3. Donna’s avatar

                  I am having a hard time finding Concerta brand or the generic from watson. My son has issued with generic and all I can get is the pink. My question to the pharmacy was “if its pink does it have red dye 40 which a lot of children have issues with. I specifically request Watson and they told me it has not been available. I also had the dr go back to do not substitute and still received the generic (which I sent back) I had to go to a different state to find the brand because not one pharmacy had it. This is getting ridiculous.Does anyone know whats up?? With our plan I can only go to cvs or rite aid.

                  Reply

                  1. Gina Pera’s avatar

                    Hi Donna,

                    Sorry to hear you’re having so much trouble. My best advice is to avoid the local pharmacies, if at all possible. If your health insurance policy includes a mail order provision go with that. Other than that, Walgreen is the only store I’ve heard that regularly carries the Watson generic.

                    tx
                    g

                  2. Helen’s avatar

                    Is there any information on whether or not Watson will continue making their generic in the same form they have been making it after the legal agreement is no longer valid in 2014? We have just started my daughter on Concerta. We got the generic (Watson brand) the first month and switched to the brand name the second month. It was only after getting the brand name that I realized that the prior months prescription was exactly the same as the brand name. My concern is that if we switch back the to generic (Watson) that they will start to manufacture it differently (more like the other generics) and we’ll be back where we tarted with paying the full price for the brand name.

                    Reply

                    1. Gina Pera’s avatar

                      Hi Helen,

                      I’ve written about the various types of generics several times on my blog. I encourage you to use the “search” function and read all the posts about generics.

                      In short, the Watson/Actavis Concerta IS the brand. It is simply marketed as a generic, price-wise. These are called “authorized generics” but it’s not a generic at all; it is the exact same Rx.

                      Best,
                      g

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