UPDATE: Janssen Quietly Ends Authorized-Generic Concerta
Previous posts now contain dated information, but they still provide a good education on generics and unique delivery systems. Here are the most recent, but there’s an entire archive!
—Consumer Q&A on Concerta Generics.
As promised, I’m following up with more details on the various generic Concerta products. Readers wrote a record number of comments and reviews on the post What’s Up with Generic Concerta?. I will try to cover all the bases but keep it simple. Look for more detail in a future post.
Thank you for your patience as I’ve tried to round up the data. It has not been easy to come by!
First A Bit of Background
It can take much trial and error to find the ADHD medication and dosage that works best for an individual. Once we find it, we don’t want it monkeyed with. So, when long-time Concerta users found that their medication had “stopped working” or was working less effectively, most could trace that change to their prescription being filled with a generic. They were understandably alarmed.
It did not help when their pharmacists patted them on the head and assured them that generics are the same as brand. It is true that generic medications generally work as well as brand, but they are not the exact same as brand. Here is an excerpt from a previous post on the topic (share it freely with any doubting pharmacists):
Moreover, as a generics-savvy physician can tell you, generics can wreak havoc with that narrow “therapeutic window” — the dose that works best with the least side effects. A few milligrams up or down can mean trouble, and the FDA allows a wide window of efficacy.
In the U.S., the FDA requires the bioequivalence of the generic product to be between 80% and 125% of that of the original product. Bioequivalence, however, does not mean that generic drugs must be exactly the same (“pharmaceutical equivalent”) as their original product counterparts, as chemical differences may exist.
The Two Categories of Generics
Here’s another big reason why many people are confused about the Concerta generics: There are at least three generics within two distinct categories of generics!
The first offering isn’t a generic in the regularly understood sense of the word. Instead, it is the brand marketed as a generic (the authorized generic). The second is a generic in the true sense of the word (in fact, they are called true generics).
1. Authorized Generic
The Authorized generic of brand Concerta was formerly marketed by Watson/Actavis/Teva; now it’s marketed by Janssen subsidiary Patriot Pharmaceuticals):
This is the brand drug marketed as a generic. The only difference is in price and name. Period.
Backstory: Originally, Watson struck a deal with Concerta’s manufacturer, Janssen: Watson would delay introducing their own generic to compete with Concerta if Janssen would manufacture and supply Watson with this brand-name Concerta. This would allow Watson to market the medication at a cheaper-than-brand price and give Janssen a piece of the profits. This deal was set to last through 2014. (I wrote about this in detail here.) When that expired, Patriot Pharmaceuticals took up distribution.
Name on the Rx: methylphenidate hydrochloride extended-release tablets
Appearance: exactly the same as Concerta. A capsule imprinted with “Alza” (the makers of the unique capsule) and featuring a laser-drilled hole. (see photos below; color will vary with dosage strength)
Bottom line: If your generic Concerta is imprinted with “Alza,” you have the brand medication. Period. Also, look for the little hole at the end; that tells you this capsule contains OROS, the laser-drilled osmotic pump that is the Concerta delivery-system technology.
[advertising; not endorsement] [advertising; not endorsement]
2. “True Generic”
(from Mallinckrodt and Kudco/Kremers-Urban @2013, but MANY more to come in the next few years; see Authorized Generic Concerta Update)
This is a generic in the traditional sense. In other words, this medication is very similar to the brand and ostensibly works as well. But it is not the exact same as the brand. No matter what some physicians and pharmacists might insist to the contrary!
When I originally wrote this post, in 2013, there were two “true generics” for Concerta. (Note: Other products might be distributed in Canada. These generics come from two companies:
1. Mallinckrodt began with only the 27 mg but now also markets its 36 mg and 56 mg generic Concerta.
Name on the Rx: methylphenidate hydrochloride extended-release tablets
Bottom line: This generic does not use brand-name Concerta’s OROS delivery system; you’ll see no laser-drilled hole on the end of these capsules, pictured below. Remember: It is the OROS delivery system that distinguishes Concerta.
2. Kudco (Kremers-Urban)
Name on the Rx: methylphenidate hydrochloride extended-release tablets
Bottom line: As with the Mallinckrodt offering, this generic does not use brand-name Concerta’s OROS delivery system; you’ll see no laser-drilled hole on the end of these capsules, pictured below. Remember: It is the OROS delivery system that distinguishes Concerta.
The box looks like this (the color varies by dosage strength, 18 mg or 28 mg):
And the pills look like this:
Dissatisfied with Your Generic? Your Options
It is possible that, for some people, the generics might be preferable to the brand; the differences in action might actually work to your benefit.
If you have regularly used Concerta to good effect, however, and your insurance pharmacy plan now mandates that you receive generic medication, what do you do? If you have tried the true generics, and found them unsatisfactory, here are your options:
- Ask your pharmacy to carry the OROS authorized generic (same as brand)
- If the pharmacy refuses, call other pharmacies in your town.
- If your health insurance includes a mail-order option (typically, 60- or 90-day supply), see if that pharmacy carries the OROS or how much more the brand Concerta will be. I find the mail-order option much easier; why go through the hassle 12 times annually if you can cut it to four or six?
- Ask your physician to indicate “no substitutions” on the Rx script if the OROS generic is unavailable and you are willing to pay for the brand.
- Ask your physician to write a note to your health insurance company saying that you or your child experienced intolerable side effects to the generic and you must have brand. (Be prepared to pay the brand price, though.)
- Ask your physician to write “OROS only” on the prescription; Watson is in the process of changing names, to Actavis, so there will be confusion if either name is used instead of OROS (the technology that makes Concerta unique).See more recent details at this post: Authorized Generic Concerta Update
Report Adverse Side Effects to FDA
Above all, if you have had adverse reactions to any of the generics of Concerta (and have not had such reactions to the brand/”authorized generic” Concerta), please do everyone a favor: File a complaint here with the FDA’s MedWatch (scroll down to the box that says “consumer”).
If the FDA receives sufficient data that a medication merits investigating, it will do so. A generic of Wellbutrin XL was recently recalled after such an effort (explained in this previous post).
Update: We did succeed in getting these initial generics downgraded by the FDA: Victory! Concerta Generics Downgraded.
Then an election happened in 2017, and an enormous number of inferior generics flooded the market. Again, see more details here: Authorized Generic Concerta Update
I hope this answers some questions and settles the confusion!
Please subscribe to this blog to be notified of updates on this continuing saga.
Gina Pera, author and Adult ADHD educator
For more information on Adult ADHD and its treatment strategies, including how to get best results from your medication, please consult my book‘s three chapters on the topic.
145 thoughts on “An Update on Generic Concerta”
Just a heads up that the link posted above (REMOVED). Etc etc I’ve left the end off) seems to now be going to a page that promotes the sale of injectable steroids. You probably want to remove that.
Thanks, Deanne. So many parasites! It’s almost a full-time job removing them.
Removed!
g
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Hi,
Thank you so much for this information. My son was prescribed 18 mg of concerta during the spring time. I later discovered that this was Kremers. This medication seemed to help, but a month later we felt that the dose needed to be increased. We were given Alza 27s. My son had a huge crash at the end of the day on this med. We ended up going back down to kremers 18. This med is now barely working. I realize Alza 27 is concerta and uses the OROS technology. What I’m not understanding is how often each med delivers medication. Should we try Alza 18? Perhaps the 27 was too much? Or is there another medication like kremers? I am just so confused. I don’t want to change anything until I understand his they work. For example, I have heard a doctor say that on 18 mg the Alza deliver 6 mg around 3 times per day and the kremers delivers 9 mg twice per day so in reality the dosing is completely different. Is this accurate? Thank you so much for your help!
Hi Courtnie,
I appreciate your confusion. It took me quite a while to wrap my head around this one.
It’s very tricky to compare dosages across different delivery systems. Even though the “active ingredient” (methylphenidate) is the same in both medications (Alza and Kremers), the way it’s delivered can make a huge difference.
Also, the release of methylphenidate in the Alza capsule is steady throughout the day, not 6 mg 3 times per day.
So, I don’t know where that doctor is getting that information but I don’t see how that can be correct.
The brand Concerta (Alza, OROS, Actavis…all these names are used to describe it) comes in an 18 mg dose, last I checked. It would be best to start there. Best rule of thumb: start at the lowest dosage and work up slowly.
Also, see my last “round-up” post on the topic of generic Concertas:
https://adhdrollercoaster.org/the-basics/consumer-qa-on-concerta-and-generics/
Good luck!
g
my son has been taking concerta for about 6months. he was 14years old at the time but now is 15years and has stopped taking concerta for about 3 months because it made him feel spacey.. he now has a girlfriend and has confined in me he is unable to get an errection… do u think this is related to concerta he has takin in the past.. he told me he was able to get an errection in the past and i told him maybe yr just nevous when yr with your girlfriend. but now im not sure thats the case.trust me i dont want my son to hav sex at 15 but i also want to know if concerta has harmed him in any way or if it will make him steryl… all advice is need and appriciated thanks
HI there.
Yes, I was wondering….do you WANT him having sex at 15? Especially with untreated ADHD?
The risks are significant for unwanted pregnancies.
You might wish to have him talk with a trusted physician. But in general, it should be determined if he can get an erection when he’s not with his girlfriend. If he can, that might mean a different set of circumstances. Perhaps, his untreated ADHD means he has trouble focusing on his girlfriend, his feelings, etc. Too many “moving targets.”
No, there is no indication that Concerta could have caused this.
Instead, it might be that it’s going without medication that he is having this problem.
If he was “spacy” on Concerta, it might have been too high a dose. If he wasn’t given a trial of the other class of stimulants (amphetamines), it might be that the Concerta class is not the best choice for him.
I really encourage you to re-open the issue of medication.
There might have been other reasons he wanted to stop. Some men with ADHD find that the stimulant curtails their once-raging libido. While that might be better for them in the rest of life (so they can focus on work, study, relationship rather than hypersexual behavior), they feel something’s “wrong” when they don’t have those constant urges any more.
Of course, it’s a bit different with a 15-year-old boy.
Good luck sorting this out.
g
Thanks for yr advice. And no I don’t want him having sex at 15.. I’ve been ignoring what he tells me because in my mind I’m thinking as long as he can’t get an erection he will not be having sex.. But it has become a big concern and embarrassing for him to the point that he has come to me crying. Which frustrates me because I didn’t want him to hav a girlfriend at 15.. but she is making him feel like crap.. Idk i jus told him to tell her she doesn’t excited him…Idk what to tell him, I thought mayb him talking Concert in the past was part of the problem and I didn’t want it to effect his future. Once again thanks
Definitely, I appreciate your conundrum. And his.
But wow, this is a girlfriend? If he’s “feeling like crap” because of his, I really hope you can encourage him to re-consider medication again. This time at a lower dose, perhaps.
If he’s placing his fragile self-esteem in the hands of this girl — and basing it on whether he can get an erection — that is not a promising path to be going down…..
Good luck,
g
Yes it is a girlfriend and he was on the highest dose 75mg. That’s y I’m so concerned. He has an appointment scheduled next week with his pediatrician hopefully this can b resolved… like I said i don’t want him having sex at 15. But he is asking questions why he can’t get an erection. He said mom i used to all the time and I’m young, I should b getting an erection when the wind blows. Jus holding concerta is hasn’t caused any harm. I will keep you up dated after his doctors visit. Once again thanks for your communication i don’t know who to talk to about my son’s situations.
I can understand your concern, Linda.
I know he’s young and male, but should he really be “getting an erection when the wind blows?”
That’s a very subjective thing, I guess.
Is he having any other physical or emotional problems, such as being more sullen or depressed? Sleeping less?
Make sure he is getting a good, balanced diet. Taking a multi-vitamin/mineral is probably a good idea, too.
It might be an interesting experiment to get back on the Concerta, this time at a lower dose, and see if anything changes.
Meanwhile, you might want to check out this discussion:
http://www.addforums.com/forums/archive/index.php/t-74773.html
g
Thanks the site.. It was very interesting, i will keep you posted after his doctors visit…
On those generic concerta pills my son would.have terrible.ticks I would refuse to get the pills from that pharmacy if they could only give me the pink ones..When he takes the white ( real.concerta ) the ticks calm down .. I do notice a big difference
Hi Charlene,
Good for you, for noticing the details and connecting cause and effect!
g
Thnx for this info i had my son on concerta but had change because of insurance. Now the new medicine I can’t get that either. This whole process is so confusing and aggravating
Hi A —
I know….That’s why I wrote a more recent, comprehensive post, in a Q&A format.
Check it out: https://adhdrollercoaster.org/the-basics/consumer-qa-on-concerta-and-generics/
best,
g
I read an article in our local paper about Mallinckrodt’s generic possibly not being as active. I didn’t worry about it because we had not used that version in about almost a year. Then my teenage daughter confided to me that she felt her Concerta wasn’t working as well, and said she much preferred the “other” one we used to get! Differences in delivery do matter and it turns out that the Mallinckrodt version really is more effective for her.
Thanks for sharing your experience, Robin. I’m going to pull these comments into another post.
best,
g
Likewise! The Mallinkrodt version worked well for my 8 year old, and his behavior, handwriting, EVERYTHING is different now that we had to switch to the ‘other’ generic Concerta. His teacher even wondered if he was still taking his medication…it’s so frustrating to not be able to get the other version anymore because that is what worked!
Hi Lora,
Are you sure you cannot get the Mallinckrodt medication now? You might want to contact the company.
I think this is the number for pharmacies to contact for orders. Maybe someone there could tell you which pharmacies might carry it.
Customer Service Toll-Free No.: 800.325.8888
Another option might be to try Ritalin LA, which the Mallinckrodt generic of Concerta resembles more than it does Concerta.
Good luck,
g
The pharmacy changed the type of generic again and things are a mess. The Mallonkradt is really the only one that works for my son so I will have to call all around and try to find someone that has it. Meanwhile my son got kicked out of summer s hill for fighting today. Had been very irritable and sleeping a lot. He has never been much of a sleeper.
Hi Maria,
If you can use a home-delivery pharmacy, there’s typically more choices. You might be able to flag his file with “Mallinckrodt generic only.”
Also, ask the prescriber to specify (though, depending on your insurance plan, this might require pre-authorization).
Also: many people with ADHD “aren’t much of a sleeper.” That’s because most people with ADHD have an ADHD-related sleep disorder.
This is something the physician should be addressing, but few have a clue.
It might be that this generic is actually helping him to focus on sleep. But the irritability…not good.
Good luck,
g
I was wondering if there was any update that you know of as to when the agreement will end. Currently my Walgreens still stocks the OROS generic but I am so afraid they will stop since we are will into 2015 now. I have to check the bottle before leaving the counter every month just to ensure I am getting it for my son. CVS has switched it on me suddenly without my knowing and it was a very awful couple months of trying to figure out it is the meds? Is it the dosage? Not fair to the kids and some pharmacists understand and some don’t care. I’m having his dr put on the RX OROS so maybe that will help me to not have to check the bottle each month.
It’s bad enough my insurance changed and is now categorizing Concerta in general, nonformulary. So now I pay an exaggerated amount just because they changed the formulary category. From $18 a month in 2014 to $90 in 2015. But name brand is still higher than that. Sigh. And in Illinois we are not allowed to order it mail order. This is a controlled substance and we can only get it month to month.
Hi Valerie,
Are you sure about that, that people in Illinois cannot order via mail, through their pharmacy benefit? If so, that stinks!
And YES, you’ll be happy to know that the agreement has been extended. I wrote about it in the latest post on this topic:
Good news! Recently, a new agreement extends the arrangement until December 31, 2017. Janssen will continue to manufacture and supply Actavis with all dosage strengths of the authorized generic Concerta, and Actavis will continue to market and distribute the product in the United States. In turn, Janssen will receive 50 percent of the net sales from Actavis.
You can read a full Q&A on the topic at my latest post: http://wp.me/p5Ilzb-10w
best,
g
Sadly, imho, Blue Cross Blue Shield took this opportunity to switch the Watson generic from a tier 1 generic (which had a $10 max on my plan) to a tier 2 preferred ($60 max). When I got my prescription filled in February 2015 I was shocked to pay a nearly 500% increase. BCBS acknowledged that they never sent any notice to customers about the change. I know that many people pay more than this due to insurance differences, but it is very bothersome that BCBS took advantage of this situation to increase prices.
I hear you, Beth. We anticipated this fall-out.
In the meantime, if you aren’t already using mail-order, it might be worth investigating.
And let’s hope that when the dust settles, the prices are reduced.
best,
g
Thank you for such a detailed explanation! I saw the warnings last year and had our physician move to “brand only”. My son called from college and said, OMG mom …I can FOCUS now. What was going on?
The Mallinckrodt worked for a while, but wore off FAR sooner than an extended release was supposed to and we saw a product release about this and changed.
I salute your vigilance, Amy!
g
I agree that the Watson generic and the Mallinckrodt generic are not the same thing but wanted to alert folks that the reverse issue can happen as well. My daughter did well on Ritalin but needed something longer to get through the day and was prescriped Concerta. The prescription was filled with the Mallinckrodt generic and she did great. We did try Focalin and OCP symptoms and anxiety were terrible not to mention 19 straight hours without sleep. We were very happy with the Mallinckrodt generic for over a year, school was better, home was better, she was happier. Then the FDA ruling came through and her last prescription was filled with the Watson generic and everything fell apart. I thought the change was going to be better for her but she did the same thing as she had on Focalin, nightmares, anxiety, fidgetty all the time. School started calling, home was a wreck, she was pulling out her hair she was so anxious. We jumped through a lot of hoops to get the Mallinckrodt back and four days later we just had our first full night of sleep in almost a month. I just thought I would post so that some folks who might not realize the change from the “old generic” to the newer version can impact kids negatively as well, particularly those who did well on Ritalin but not some of the other stimulants. My heart is with all of you advocating for yourselves and your children. I am a nurse practitioner and it is still hard for me to make our system work for my children. Hang in there and don’t give up!
Thanks, Beth. A few people have experienced similar.
It all drives home the point that stimulant dosing/profile is very individualistic. What works for one person doesn’t work for another. That’s why it’s a good thing we have so many options today: to increase the chance of finding a good fit.
Just to be clear, though: The Watson/Actavis generic is not “new.” It is the brand, marketed as a generic.
This is my most recent post on the topic:
https://adhdrollercoaster.org/the-basics/consumer-qa-on-concerta-and-generics/
I see the date on this posting is old so I don’t know if it is still active. I have been using concerta since 1998. After the generic came out I started to notice that every once in a while I would get a whole prescription filled that just would not work. Believe me when I say that, I do know the difference, but the pharmacy would only say I was building up a tolerance to the drug. But then the next prescription would work just as it always has. As I have always been telling myself, I never want to go back to where I was without concerta. Over the past three years I have been slipping back to the way I was. My insurance company would not let me increase my dosage, and my new doctor didn’t feel comfortable increasing it with the way the dea and news media have been dealing with”addiction”. I believe she believed me, but what could she do. I believed something was going on with the drug, the manufacturer and the insurance companies but who am I to know what. I do know one thing and that is I never buit up a tolerance to it and when it didn’t work it didn’t work for a reason. I have discussed this with my physician at length. Tried switching to Ritalin, but starting out at such a small dosage she started me on, out of panic I went back to concerta. My sleep apnea doctor, after all the years, started to believe me when I told him my theory on depression, adhd,etc. and energy were caused by improper sleep, by not getting into senseless sleep. He has put me on aderal along with nuvigil, another 600 dollar prescription. It works, but in a different way. The dosage of aderal is way to low, but it is the highest they will allow me. I know what is going on is not right, (drug makers, pharmacies and insurance companies), but what, and what can be done about it. I am writing a book started in 2005, about what is not right in the world today and what needs to happen in order for it to change, and it is very simple. If I do complete it the name of it is AM I RIGHT, The Matter of One’s Own Self. Because of these medications now, I don’t even know if I am capable of writing or even living much more. Edward
Hi Edward,
Did you notice that the various prescriptions of Concerta didn’t look the same?
If Concerta worked well for you, for so long, why not try to go back on it?
The main thing is to stick with the brand and the “authorized generic” (same as brand).
Ask your MD to specific “OROS only” (OROS is the novel technology in Concerta’s delivery mechanism; an osmostic pump in the capsule).
best,
Gina
Recently my normal pharmacies were out of generic concerta. So cvs had some. (They looked different)Three days later I’m about to pull my hair out with my daughters behavior. Call the pharmacy and they said they just received an email but their med was approved. So I started researching! The pills they sold me are the controversial pill only listed manufacturer kremers urban! If it wasn’t for your website I would have still Been confused. I think the ones in charge should get a dose of meds that produce the same horrible effect it has had in my daughter!
Thank you for this post. I found this doing a search on the difference between The Watson brand and the Kremers-Urban. What is interesting is that I’ve found the opposite problem. My son has been taking the Kremers-Urban brand for months until last month when we got a batch of the Watson. He has been having major rage tantrums in the afternoons. So much so that yesterday he punched my car window in anger and frustration (after kicking the back of my seat so hard I pulled over and got out of the car to give us both some space from his screaming at me that we were going to be on time – he wanted to be *early* – to his soccer practice BECAUSE I HAD TO PEE BEFORE WE LEFT THE HOUSE). I’m thankful he didn’t hurt himself or break the window. I’m unsure of what to do (just now sent in a report to the FDA) because we still have another 2 1/2 weeks worth of medicine and we can’t handle much more of these rages yet his grades tank and his behavior in school suffers when he’s not on the medicine…
Hi Alissa,
My observation is that yours is not a problem with the quality of medication. The problem is one of dosing. And, there is no reason or basis for complaint to the FDA.
Your son might be one of those people for whom the delivery of medication works better with the Kremers-Urban generic of Concerta.
All of these products (Concerta and its generics) contain the same medication: methylphenidate. The only difference is the rate at which the medication is released. As I recall, Concerta is released at at steadily increasing rate, which fits most people’s needs. It could be that the higher rate in the afternoon is adversely affecting your son.
Whatever the case, please do not insist that he stay on this medication that is obviously causing problematic (if not outright dangerous) behavior.
Call the physician, explain what is happening, ask for a Rx for the generic, and then try to find the Kremers-Urban generic.
Good luck!
g
I simply desired to thank you very much once more. I do not know the things that I might have sorted out without the entire hints shared by you regarding such a concern. It was a very fearsome circumstance in my opinion, nevertheless coming across this expert approach you solved it took me to weep for joy. I am happy for the assistance and in addition hope that you know what a great job you have been accomplishing training people through your web blog. I’m certain you have never met all of us.
Hi Gina,
I just discovered these posts and I’m happy to see all of the work and information you’ve been putting out there. I tried to search this post and do some google searches, but was unable to find any solid information on what exactly happens at the end of 2014. When the deal is complete, will Watson then put out their own generic, which is not an authorized generic and thus not the same?
Thanks,
C
Hi C – That’s the BIG question.
My sources speculate that the deal will probably be extended, as it’s advantageous to both parties.
I will post as soon as I learn anything.
tx
g
I have been taking Concerta for several years. The pill I’m taking now says alza 18 and has a circular indentation on the bottom, so I assume this is the authorized generic.
Periodically I’ve gotten a little too “crazy” and my doctor has me take two consecutive days off, assuming I’ve developed a tolerance. This has helped in the past.
But for the last month, it seems like it’s stopped working altogether whether I take the two days off or not. Do you think it’s possible, since it is now 2014 and the patent is no longer valid, that even though the pill looks exactly the same they have changed something in the compound?
Karen – no, I think your reaction to the medication involves other factors. Perhaps it’s affected your serotonin response (that can happen over time, especially if there is a vulnerability to depression/anxiety). Perhaps your dopamine precursors are depleted (look into the amino acid L-Tyrosine). Perhaps your hormones are fluctuating. Lots of factors. But no, I don’t think the change is connected to the pill itself. These things are tightly regulate. If it says Alza, it’s the real deal.
g
Has any one found a major chain pharmacy that continues to carry the Watson/Alza/Actavis form of Concerta, other than Costco? My local Costco continues to carry it because of the differences, but sadly, they do not accept my insurance. For others, however, try Costco.
Anna
Hi Anna — Some readers have said that Walgreen’s carries the Watson, etc. Concerta.
Good to know about Costco, thanks.
g
Hi Gina,
Thanks for writing about the generic Concerta issue. Have you had any luck with your request for information on the release profile or pharmacokinetics of the true generics?
I’m willing to concede that a generic without the OROS system could be as effective, IF the release profile matches or is even similar to that delivered via OROS. But if they won’t release the information, how are we to make an informed choice?
Thanks again – Allen
Hi Allen,
It’s been an exercise in frustration. Yes, I would be willing to cede the point, too, IF the generics work as well as the OROS Concerta. But there is no data demonstrating that — and plenty of anecdotal reports to indicate they do NOT work as well.
The OROS delivery system, which is inherent to Concerta, results in the medication being delivered in an “ascending profile” throughout the day. In other words, it steadily goes up before starting to decline.
As best as I can determine from reading papers far over my head, the “true” generic manufacturers (i.e. Kremers-Urban, Mallinckrodt) were allowed by the FDA to use Concerta’s pharmacokinetic data and clinical trials as part of their own submission.
In other words, the generic companies were not required to conduct comparison studies and demonstrate that the products work as well as the brand drugs in real people.
My medical/research sources have assured me that the Mallinckrodt product, for example, is little more than Ritalin LA. That’s a relatively simple delivery system, with one bolus delivered at the start and the next delivered about 4 hours later. (Don’t quote me on the hours; I’m going on memory now.) The point is, that still creates a “Ritalin Roller Coaster” effect. Up. Down. Up. Down. Not steady, and steadily ascending.
The irony in all this is that so many people love to rant against “Big Pharma” when really it’s “Little Pharma” that posts larger dangers, as far as I can see. We can protect ourselves from the marketing practices of Big Pharma by carefully deciding with our physicians the medications we need or do not need. But with Little Pharma, all bets are off; we don’t know what we’re getting. And because these generics are more profitable to drugstore chains and less costly to insurance companies, they are foisted upon us without choice.
In short, Allen, the “informed” choice for now means either avoiding these generics or trying them after you already have a baseline with brand, so you can judge for yourself.
best,
g
The generic of Concerta is now on the FDA Adverse events Watch List!
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm391572.htm
Thanks for encouraging people to report their issues with this poorly formulated drug!
Thanks, HC! I’m thrilled to learn this. I will be writing more about it soon.
And thanks for writing a comment on the Medpage story. Those other commenters hadn’t a clue!!
tx
g
We live in Orange County, CA and just received a 90 day supply of generic Concerta made by Kremers Urban from CVS when it has always previously been supplied by Actavis. Needless to say I have been scrambling for 2 days visiting every pharmacy in our area to see if anyone carries it from Actavis. Walgreens is the only local supplier, however, they are at the mercy of their buyer so can’t determine what will be supplied when the current supply runs out. None of the pharmacies can “special order”. As soon as I get the new RX from the doctor I will have to pay cash for the 90 day supply as Insurance has just paid. Has anyone contacted Actavis to find out who they are supplying the drug to or is Kremers going to rule the market? Also does anyone know what the price difference is between the 2 manufacturers? It all boils down to money.
Yes, Cathy, it all boils down to money.
The pharmacies make more money on the generics than they do on the brand. So, make no mistake: The pharmacies’ priority is not your well-being but their bottom line.
As for the price difference between the two manufacturers, I doubt there is a solid number. It’s all in the individual contractual agreements.
The best bet is to avoid local pharmacies and use your insurance benefit’s 90-day mail order supply (if you have such a benefit). These mail-order fulfillment pharmacies are much larger and don’t deal with the constraints of local storefronts, such as worrying about robberies of these medications.
Good luck!
g
I can’t remember if I posted earlier in the comments, but I just wanted to say thank you for this page. 3 months ago my daughter was in a complete tailspin. She had begun going downhill in November of last year when she was changed from the Watson generic to Mallinckrodt. The medication didn’t seem to be working as well but we had JUST had a dose change so we weren’t ready to do it again and it had been working amazingly well for her until that point. Then in January, the pharmacy switched to Kremers…ugh as bad as the Mallinckrodt was, the Kremers was 100 times worse. She started crying ALL THE TIME, was combative and was really struggling after lunch in school (it worked semi well until lunch time but then wore off). My husband had picked up her prescription that month, and I looked at it and realized that they had changed her generic again (that would be the 3rd she was on in less than 6 months). I began researching and found this site. I called her doctors office the next morning and called every pharmacy in the area until I found one that carried the Watson/Actavis. Doctors office didn’t really take me seriously but gave me a new prescription to try it (they wanted to switch her to a new med). The Rite Aid pharmacist told me i was completely incorrect and that they were exactly the same med (and this is why I will no longer have a prescription filled at Rite Aid!!!). Called a small, local pharmacy, talked with the pharmacist who not only agreed with me, but has several other customers having the same issue and finds it appalling. Right now he only stocks Watson/Actavis, and will until it is no longer feasible for him to do so. I am so thankful that I found this pharmacy, and that I now have a pharmacist that not only understands the issue (he told ME it’s not the same delivery system, I didn’t have to argue with him!!) but is doing whatever he can to make sure that he gets what his customers need for as long as he can.
At that point I have absolutely no idea what we will do for my daughter when the time comes that he can’t get the Actavis as she just metabolizes the non-OROS too quickly. I feel like we’re on borrowed time until we have to start all over again as the insurance company will pay 50% of the brand name, but that still leaves us with $125/month which we just aren’t able to do :(.
INCREDIBLE!!!
Sandra, I am so gratified to know that my blog post might have helped to steel your resolve in wading through all this …. what shall we call it…it’s much more than nonsense…it borders on sociopathy. The careless regard all of these people and institutions, from these generic manufacturers to the marketers to the big-chain pharmacies, it’s just mind-boggling.
Where’s the New York Times’ Alan Schwarz when there’s a legitimate news story about ADHD? No, this isn’t sensational enough.
But good grief! Look at the effect on your child! And multiply that time the thousands (millions?) of people enduring the same thing.
This is just outrageous. Please file a MedWatch complaint, as linked in my blog post. This is the only way we can fight this awful trend.
Thanks and kudos to you for being a vigilant mom and consumer!!
Gina
I filed one when I first read this. It is so beyond frustrating to me that they can claim they are the same when the thing that MAKES CONCERTA CONCERTA is missing. I have no problem using generic medications, and generally prefer to do so, but my expectation is (and should be) that they are the SAME, including how they work! My daughter was on Ritalin LA previously, which helped but didn’t last long enough…we switched to Concerta for the delivery system but it was like just being switched back to Ritalin on the non OROS generics. Makes me want to smack someone at the FDA.
Hi Sandra,
I know. I know.
Actually, someone at the FDA has been very helpful to me in trying to sort out these issues. I think the FDA scientists don’t like these problems any more than consumers do. I’m not quite sure how the decisions are made; it seems that the FDA director has a lot of power in establishing policy. I cannot help but think it is influenced by industry. But probably there is also government influence and also health economists (who have done some of the WORST studies on ADHD). Even Consumer Reports got into the act, with this awful article on how generics are just as good as brand and parents should eschew brand!
https://adhdrollercoaster.org/the-basics/consumer-reports-on-vacuum-cleaners-maybe-on-adhd-medications-definitely-not/
It always strikes me how everything about ADHD involves confusion–having it, getting treatment for it, and especially writing about it!
Thanks for filing the complaint. I know it will help!
g
Thank you for posting this; I had no idea this kind of nonsense was even legal. :/ I’ll be pushing for Waston or brand when I go to fill my new script so that I know it’s the Concerta that doesn’t work and not the crap generic that doesn’t.
Smart move, Rudje. Actually, this “nonsense” has been in place for a long time. I was one of the first ADHD experts warning about the differences with generic medications for ADHD. Generics might work well for other conditions, but the stimulants require precise fine-tuning with dosage; it’s not the medication to be all loosey-goosey. 🙂
best,
g
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My Daughter has been struggling with Her concerta for months. Now we know why. I’m now struggling to get her on brand or authorized generic. She was switched to Mallinckrodt and the difference is extremely noticeable. It takes forever to work and lasts maybe 4 hours. Its not fair to my daughter either. Now I have to fight prescription insurance, and pharmacies just to find brand or authorized generic. I don’t know how or why these drugs can be classified as generics. They aren’t generics they are their own drug. This is so disappointing.
HI Justin,
At least you know it’s the medication. I hope you will consider filing a complaint with the FDA, as listed in the post.
best,
Gina
The Mallinckrodt generic was wearing off within 6-8 hours and making my mood unbearable. I have been back on the Alza Concerta for 4 days and I can already tell a difference. My doc’s pharmacy had a tech tell me that she wasn’t even going to try to request authorization from TriCare because they would just deny it. My pharmacy at the Army Hospital was able to fill it but warned me that there is a huge possibility that they won’t have it next month. One of the techs also told me to have the doc put “name brand only” rather than “OROS formulation only”, because “Nobody knows what OROS formulation means anyways”.
Hi Aubz,
Good point about nobody knowing what OROS formulation means. 🙂
I made that distinction because it might mean a huge difference in cost for some people. The Actavis authorized generic is typically much cheaper than the brand (even though they are the exact same medication).
Best,
g
Thank you for this! My son was on the Mallinkrodt generic with fairly good success. My local pharmacy switched us over to the Kudco product. I was hestiant but willing to try it. What a disaster the Kudco product is. His first day back at school on the new medication, he got detention for talking back to his teacher.
It is criminal that the FDA approves generics based upon their chemical compound and not how it actually works. It is worse that we have no advocates for ourselves out there. The Pharmacies go lock step with the drug companies with no regard to the patients.
You are doing a great service here Gina, thank you for everything you have done so far!
Thanks for noticing, Chris!
I’m not sure how the policies regarding generics are established. But I can imagine that drugstores and generic manufacturers have some input; after all, they are the profiteers when it comes to generics. Much higher profit margins for the drugstores with these “knock-off” generics.
Yet, other parties hold responsibility, too. I remember reading a Consumer Reports issue a few years back touting the idea that generic Rx for ADHD were just as good as brand. Oh wait, I wrote a blog post about it. 🙂
https://adhdrollercoaster.org/the-basics/consumer-reports-on-vacuum-cleaners-maybe-on-adhd-medications-definitely-not/#.Uvw2hl6YvZo
best,
g
I talked to the pharmacist at Optum Rx and they only used Mallinkrodt as their generic. So brand name Concerta is the only way to go from the mail order pharmacy. They are now telling us that the doctor must fax an appeal to UHC – the sage continues…
Hi Marcy,
The insurance company might require that the patient try it first, and then allow the brand if there are adverse effects.
g
After researching Mallinkrodt generic, we changed our insurance coverage during open enrollment and verified that brand name Concerta would be covered with Physician authorization through mail order. When we sent our prescription in to be filled (UHC/Optum Rx), they told us it would not be covered – only generic. After finding out the generic is Mallinkrodt, we have been fighting for the coverage they had promised. I’ve spent two weeks back and forth (UHC says it’s covered, OptumRx says it’s excluded), the doctor authorizes brand name, etc. and still no luck. Now I’ve been calling around to find out what pharmacy in our area carries the Watson (now Actavis) generic with the OROS delivery system. So far, I have found Walgreens does carry it and they say it is the only generic they carry for Concerta. Yea!!! I thought I would share this for others and hope that you also have a Walgreens in your area. Thank you, Walgreens! I just hope that they don’t also bow to the pressure of carrying the substandard generic (Mallinkrodt and Kremers Urban) as other pharmacies are. I’m still fight with UHC/Optum Rx to honor the coverage they promised, but I’m losing hope. If you can avoid this insurer, please be advised!
Hi March,
Good for you, for being so persistent. Many people with ADHD find it extremely difficult to be so persistent, so this change is doubly cruel for them.
Did you try, with the mail-order, not asking for “brand” but specifying “OROS” only — that would include the authorized generic from Actavis. Sometimes it’s all in the lingo you use.
Good to know about Walgreen’s.
good luck!
g
I have always gotten the “true generic” of 54mg, but when I filled my prescription at CVS this past week I received a pill I had never seen before, in an odd shape. Thanks to your blog I found out it was the Kudco/Kremers-Urban Concerta generic. It is disturbing for me to take it, because there is literally no information online regarding it… my pills do not even have “M 54” on them, just the number “54”…
Have you heard any updates regarding this generic? Thanks.
Hi Paige,
The Mallinckrodt generics have the “M,” not the Kremers-Urban generics.
Of course you can try it; maybe it will work.
But the reports thus far are not good.
I have scheduled an appointment today to talk with a patent attorney about this mess. Apparently, there’s a lot of controversy about what’s happening re: Concerta generics.
Stay tuned.
g
I also had the Watson/Activis substituted at CVS. I felt bad on it too. Nervous for a few hours then teary and depressed and exhausted after a few hours. After getting a fresh script I tracked down some original compounding again. But I ran out New Year’s Eve. This time I couldn’t find the good stuff. I had to try the Kremers Urban again. Same result and a very uncomfortable New Year’s holiday. With two separate experiences months apart I can confirm its not in our minds. I think it is dangerous with these side effects. How many kids will feel crazy and not be able to express themselves?
I know, Jesse. It’s unconscionable, isn’t it.
Thanks for adding your voice of experience.
Gina
I got the Kudco/Kremers-Urban generic for my son, it is unbelievable that the FDA can approve this pill as a generic for Concerta, it has nothing to do and the side effects on my child were terrible, I didn’t know what was the problem with him until I realized that it may be the new generic ( I always got the Watson generic), now he is much better because he is taking Concerta, I had to pay for brand name because not one pharmacy in my area (NJ) will carry Watson/Actavis generic, I don’t know why the Watson is not available, I called every pharmacy around and they said that their supplier will not take orders for Watson, I had my usual CVS pharmacist order the Watson especially for me but she got more of the junk generic. Of course I already filed a complaint with the FDA and everybody with a problem should do the same.
I know, Bi. It’s outrageous.
Thanks for filing your complaint with the FDA.
best,
g
I have had the new true generic for a few weeks. It is also my first script fill bumping my doese from 54mg to 72mg. I am a wreck and making my husband miserable! My brain has stopped functioning with this switch. I get mine at CVS. They warned me a few months ago that people were having problems with the new generic, but I forgot about it because they kept stocking the original OROS. I have been on the OROS for years and it works beautifully. But now that I have the generic, I’m going to have to hunt around for the OROS. I almost feel like at this point I’m worse on the generic than with no meds. This is so frustrating and upseting. Thank you for this information!
Hi Erinn,
Sorry to hear that you got a double-whammy– dose change AND different generic.
That’s two huge variables to wrestle with.
Nice of CVS to warn you, but a warning at the cash register would have been nicer!
I’m glad this info helped you.
Good luck!
Gina
I was switched out in May of 2013 and have to search every month for a pharmacy that have the OROS medication. I reported it back in May to MedWatch and with current complaints here as well as other sites I am amazed that they can sell this with the claim it’s the same as Concerta. Truly a disgrace to the FDA process!!!!!!!!
I agree, Scott. It’s outrageous.
Why isn’t the New York Times writing about THAT if they care so much about people with ADHD?
(Answer: Because they don’t. They care more about sensationalism that drives web traffic.)
I encourage you to look into any mail-order pharmacy benefit you might have. It makes life MUCH easier. 60- or 90-day refills minimizes the number of times you have to hassle with getting the prescription, etc.
Thanks for reporting your experience on Medwatch!
Gina
This is great information! I encourage everyone to talk to their physicians about it. I am amazed how many pediatricians in my area who don’t know that there are generics yet. Please spread the word!
Great idea, Kristen. I hope this information can save many people a lot of distress.
g
I was actually thinking of uping the dose or switching to different brand due to the fact that I felt it was no longer working for me and in the process stumbled along here. I am glad I came across this, and am feeling frustrated but relieved at the same time that its not just me. I am frustrated because I cannot find this pill anywhere it looks a lot like some of the ones floating around (It’s the solid red pill) but it doesn’t have the ‘M’ printed on it. Just 36. So I am wondering what generic version they are even giving me. I know my doctor writes out “CONCERTA 36MG” and yet I still get the generic version. I started doing redbull in the mornings because it’s just not working for me like it did when I first started taking it. Now I am p***** off because I filled it yesterday (Have the generic one) and I feel like there is nothing I can do until next month. But what are the repercussions until then?
I have often felt like I am just taking a placebo pill and that it is not doing anything at all..
Kimberly – the pharmacy owes you answers — the name of the generic manufacturer, if nothing else.
Also, it doesn’t matter if your physician writes “Concerta 36 mg”- if the physician does not specify “no generics,” you will get the generic.
Instead, ask that OROS ONLY be written on the prescription.
I would not take this lying down, if it were me. I’d take it back and complain. And ask your doc for a new Rx.
good luck,
g
They wouldn’t take it back, I tried. I called my doctor to see if they would just write out a new one, and I am not sure how that will go since it is such a controlled substance. I am waiting to hear back from the doctor.
The only reason I use that specific CVS is because it is a 24 hour one, which fits my work schedule.
I didn’t expect the pharmacy would take it back once you left the store, though at least one reader has reported that experience. But at least you would have registered your complaint.
Also, call your health-insurance company to complain.
I would also encourage you to use the 90-day mail-order feature of your healthcare coverage, if you have it. That makes it a LOT more convenient.
g
Gina,
After years of taking 36 mg of Concerta, last month, my prescription was filled with the Kremers Urban generic. This began my nightmare. Briefly, taking this pill made me feel violently angry, jittery and it was completely ineffective at controlling my ADHD symptoms. I was a total mess, both at work and at home. After about two weeks of this, I ended up getting my doctor to write a new prescription for the brand name and paid out of pocket, since my insurance had already covered my refill for that month. Of course, this immediately fixed my problems and I was back to my old self. My kids and friends were also very relieved, as I had apparently been extremely short tempered with them while taking the Kremers generic.
Anyway, being a research scientist with a PhD in biochemistry and a background in pharmacology, I would like to understand the differences in these drugs, as they are clearly NOT the same. To me, it seemed that the Kremers generic gave me a much higher dose early on and it wore off hours earlier than the OROS Concerta. It seemed that I did not get the same therapeutic blood concentration with the generic, it was either to high (early in dose) and too low (later in dose).
Do you have links to any of the actual data files for how the Kremers Urban generic profiles compare to those for Concerta? I know that you mentioned previously that you had obtained the Mallinkrodt data through the freedom of information act. Also, I noticed in the package insert for the Kremers generic, that the plot for mean plasma methylphenidate concentration over time is IDENTICAL to the plot found in the brand name Concerta package insert. By identical, I mean that it is the exact same data graph except that the figure key was altered to read “Methylphenidate HCl Controlled release tablets” instead of “CONCERTA.” Doesn’t the generic company have to show their OWN product data instead of just copying it from the brand name version?
Hi Sarah,
Apparently, no, the generic company does not have to show their own product data; it’s considered proprietary information. (Yeah, I know….)
I did file the FIFA request for this information, and recently I received the report on the Kremers-Urban/Kudco generic.
Unfortunately, it is entirely over my head! My husband (a life scientist) reviewed it, and he wasn’t impressed with the results. But he’s not qualified to give an official interpretation.
I’ve been in touch with some leading ADHD researchers, and I hope to conduct a Q&A with them on this current spate of Concerta generics. Stay tuned. I know that many are as angry about it as we are.
PLEASE, PLEASE, PLEASE file a complaint with the Medwatch link I provided.
Thanks,
g
I have already filed a complaint with Medwatch a few days ago, thanks to your link. And thank you for keeping up with all this. Information that I have found here has helped confirm that my experience was not unique and/or not just some “all in my head” placebo effect.
Now I guess I will also need to file a FIFA request to get the info that I want on the Kremers generic. What specifically did you ask for? Was it the ANDA application from the FDA and did it take long to get?
Hi Sarah,
If I could, I would share it with you. I’m not sure of the legalities on that. And no time to check today.
It took about 4 weeks to receive the document.
APPLICATION NUMBER:
ANDA 091695Orig1s000
BIOEQUIVALENCE REVIEWS
It looks like the final date is 4/6/12 (though it was originally submitted in 2009).
Here is the concluding comment:
THE OUTCOME OF THIS ANDA IS ON HOLD PENDING THE AGENCY’S FINAL
DECISION ON METHYLPHENIDATE HYDROCHLORIDE EXTENDED- RELEASE
TABLETS GUIDANCE.
I don’t get it. This generic is in distribution.
It’s probably also worth pointing out that I was using CVS because they were the cheapest using GoodRX. I have insurance, but with a $250 deductible and it being near the end of the year, I would have had to pay that all out of pocket. With the CVS Concerta ER Generic, It was only $74.50 so the math worked.
I’m explaining this all to say that you may be able to get a refund and take it elsewhere – but if you’re using REAL insurance and not GoodRX or paying cash I wouldn’t expect your insurance to be as forgiving on processing the claim twice in such a short period as they probably won’t be immediately notified of the reversal of the initial prescription.
That’s great, Jimmy. I have a feeling you lucked out with a very nice manager, too.
And definitely, it is worth trying!!
I will include your point when I write a new wrap-up.
tx
g
Thanks for the amplification.
That’s also smart of you to calculate to see if it would be cheaper WITHOUT using insurance.
That happens a lot, but people don’t realize it.
g
goodrx.com is pretty amazing. The only problem is using it doesn’t hit my deductible – but sometimes it can be worth it because it really knocks the price down (and lets you price shop pretty simply for cash prices).
Good to know, Jimmy! I was unfamiliar with that site.
g
Filled my generic tonight at cvs and got the new non-OROS. I’m going to return it tomorrow morning – walgreens has the OROS generic and is only $20 more. Worth it, in my opinion.
Oh yes, JM. That’s not a hard one at all! 🙂
g
Do you think they’ll let you return it? I was told that once you leave the drugstore with it, nothing can be done. I also just picked up a refill from CVS and didn’t know that I was given the new generic until a day later. I’m figuring we’re (it’s my child’s prescription) going to have to suck it up and try the generic for a month and then move the prescription elsewhere. Glad to know Walgreens will be an option!
No, you cannot return it.
It’s always a good idea to check the prescription receipt, no matter the type of medication. Pharmacies can make mistakes.
g
It’s with the pharmacist now. We will see. Worst case I bought it with my Amex so I have buyer protection and they will refund
Did you try it, JM?
I would think you couldn’t return it unless you try it and have adverse side effects.
g
Just talked to the Pharmacy Manager and she is going to refund it and give me my original prescription back so I can take it to Walgreens. Your mileage may vary – but they were very understanding. I did not take it first – I just explained the them that I was newly put on the medication (which I was a month ago) and I didn’t want to have an adverse experience on it based on what I’ve read about the delivery mechanism differences in the OROS packaging vs the generics.
Tammy — for the future, I list the options you can take in the blog post.
You could try the Kremers-Urban generic and, if it is unacceptable, call your insurance/RX company and say that the switch in manufacturers has resulted in intolerable side effects. Ask for approval to get the Rx re-filled, this time with the authorized generic or brand.
By trying the generic, you will be able to say that you tried it and it didn’t work. If you try to argue that you don’t want the generic, that might be a losing battle.
As for your pharmacist, ask where he/she got his/her pharmacy degree: Google? 🙂 Tell this person that you are simply explaining FDA guidelines around generics. Ask this person to put his/her opinion in writing. 🙂
good luck,
g
I just got a “surprise” prescription of Mallinckrodt this weekend (had been on the alza/Watson/Actavis and was quite happy with it). Took the first pill of my new prescription yesterday, and didn’t feel anything. Today, I am sweating, but have chills in hands and feet, slightly dry mouth, but the biggest problem is that I am “speedy”. Can’t think straight, jittery. A trainwreck if I can’t get this fixed as I’ve been doing very well in school and have finals and end of term papers in the next two weeks.
Yikes, Jules, better make getting a new Rx the top-priority then. Please don’t delay!
Good luck!
g
Yeah, no kidding. The timing is awful.
Yes, it is. Cruel, even. Argh.
But you should be able to take care of this pretty quickly. Call your Rx provider and ask what can be done. Meanwhile, ask your doc to write an “OROS only” script.
g
Yeah, bad thing is I moved out to California, and have been having a heck of a time getting “into the system” out here (I’m a retiree so am eligible for both Tricare and VA). I’ve been relying on the very helpful VA back in Nebraska, but they’re getting uncomfortable with our “long distance relationship”. Worse, both places are now served by Mallinckrodt – who won the latest contract, probably for all of DoD and VA, from the looks of it. I hope to eventually get what I need, but I have a feeling it’s going to cost, and it may take longer than I have.
Darn.
Well, you could let them know that you are working on the transition and appreciate their help for just a short while more.
And, it might be that they can still get the OROS, but that it’s not their primary source.
g
Hi Gina. Any advice on which mediciation doesn’t cause loss of appetite! My 8yr old daughter started on 18mg ‘Watson’ concerta for 3-4 months with weight loss (5-6 lbs) then Dr switched her to Focalin for 1 month and still lost 2lbs. Dr took off and it’s only been a week and school work is starting to suffer!!! Any advice?? He quickly mentioned at last appt to look into Strattera, so I am just starting to now.
Deana,
This is something your physician should be helping with. Does he or she have no ideas?
Some physicians prescribe an antihistamine called periactin:
http://www.addforums.com/forums/showthread.php?t=60038
If your daughter also has depression/anxiety (that is, “serotonin issues”) the stimulant can exacerbate those, perhaps decreasing appetite. Many people with ADHD need both a stimulant and a serotonin-targeting medication.
I’m not familiar with the chemical structure of periactin, but many antihistamines have an anti-depressant effect.
Please ask your MD about it before switching to Strattera.
g
Watson was to change names to Actavis, and I assume already has done so.
If your Dr. is writing for Concerta generic Watson, regardless of name change to Actavis, it might help to have “OROS Delivery System only” on the prescription. Mallinckrodt brand should never be substituted for any drug that specifies this delivery system as it does not use it.
My son had a bad experience with Mallinckrodt, and his physician’s office has had numerous complaints from patients on this generic and will only prescribe the Watson OROS Delivery System for patients. If pharmacies refuse, I would go elsewhere.
Yes, TAG, that is best: specify OROS delivery system only.
mallinkrodt is the only generic brand that works good for my son. This generic has the least side effects. I am not sure why all the complaints?
Hi Susanna,
It sounds like you are comparing generics, not generic to brand. Other readers are comparing the Mallinckrodt generic to the brand.
So, when you say that Mallinckrodt is “the only generic brand that works good for my son,” you’re saying nothing about how it works compared to Concerta brand. You are also implying that he has tried both the Mallinckrodt and Kudco generics, and found the Mallinckrodt works better. Is that what you mean to say?
g
Question: I think I read on the internet that Watson has changed names to Actavis. Should we be asking for Watson or Actavis? So far Krogers and CVS don’t have Watson. Then it hit me should I asked for Actavis Pharmareuticals concerta? Thanks for the great information… Glad I found your blog.
Hi Stephanie,
I haven’t heard of needing to specify Actavis, and I was just talking about this issue yesterday with some US ADHD specialists (psychiatrists), while speaking at an ADHD conference in Mexico City.
If I heard that is the case, I will post about it.
tx
g
Thanks for this info. I reported the Mallinkrodt issues to the FDA this weekend. My 8 year old son actually developed a few tics within a week of taking that brand. We are doubling up on his 27mg leftovers until we talk to his Doctor. The tics and other undesirable side effects stopped when we went back to Watson. So far both Target and Walgreens have switched to Mallinkrodt. CVS still has Watson (for now, at least.)
Good for you, Rona. I hope others will follow suit in reporting the issues.
best,
g
Yeah I hadn’t clicked around yet. I had just found your blog and didn’t want to lose that page! I am subscribed though. The blog looks great. Thanks for the information. It’s bad news and I promise not to shoot the messenger! Part of me says switch to the brand now but if I have time with Watson and my pharmacist will give me a heads up when the pills look different, I can save some money and hopefully not end up with pills that don’t work. A good pharmacist and being informed make such a difference. Thanks for helping with the being informed part.
Hi Danielle,
I understand “shooting the messenger.” I’m pretty ticked about this, too. For my own household and the ADHD community at large. How dare they mess around with our lives in this way.
I’ve written several posts about generics, so you can also search the blog for more background.
I would say the best strategy is to ask your doc to stipulate, “Watson authorized-generic only; otherwise, brand.” But of course your physician will know the best exact wording, given this information.
good luck!
g
Has anyone done ok on the Mallinckrodt generic? I just changed doses from 36mg to 27mg pills and the pharmacy didn’t have enough to fill a whole month so I ended up with some of each. I’m glad they gave me the Watson first…
I have a lot of issues and I’m having trouble with staying on task and I’m not sure if it is the dose reduction or one of the many other things changing as well (would love to change one thing at a time but it’s hard when physical issues creep up 12 hours after the decision to change a psych med). I haven’t seen anything good and 1/3 of my pills are Mallinckrodt. I’m afraid to try them now after hearing pretty much nothing but bad experiences.
This is just a really bad time to be switching brands. The dose changed, I’ve had some physical problems and lots of additional meds since deciding to change the dose and I don’t know what is what because there are too many things changing all at once including my physical wellbeing. Even this response seems scattered (it’s taking forever because Im trying to edit and put matching paragraphs together) and I don’t want to go back up on the Concerta right after deciding it was too much and making me feel bad until I know it is reducing the Concerta that’s causing the problem. Now I have a brand change in the middle of the month and my other issues won’t be worked out by then.
I don’t know if there is anything I can do about the pills I already have. It took a long time to find Concerta and the delivery system seems to be key. Without the OROS, what makes it generic Concerta instead of just another generic time release Ritalin? I thought the word Concerta would get me OROS. Isn’t that what makes it Concerta???? I already can’t stand pharmacists who tell me generic is same and then get annoyed when I give them a 30 minute lecture on binders and transport mechanisms and looser FDA tolerances and fillers that maybe I’m allergic to all being different so I don’t care if the active ingredient is the same, the drug is completely different. They can’t argue because I’m right and they are used to being on the other side of the lecture. I have some issues but that doesn’t make me stupid and uneducated. I think it is the condescending tone that sends me into lecture mode and that seems to only happen at the big chains. OROS is what makes Concerta Concerta in my mind.
Do I now need to pay attention to the methylphenidate interactions with my other meds that don’t apply to Concerta because they have to do with coatings that Concerta doesn’t use? Is it like Ritalin LA? This should be readily available information because it really matters. There should be no need for freedom of information act here. If it doesn’t act like Concerta, it shouldn’t be called generic Concerta especially with medication interaction potential and other such consequences. This is a completely different drug in my mind and I can’t get a monograph? This caught me off-guard. I’ve never seen it before and there’s no way to combine pills to get this dose which is why it is so perfect for me. With the new controlled substances law, I may be stuck with 10 days of this stuff. It treats more than just ADHD for me. You can see why I am afraid to try it. Maybe switching me to the brand will get me around the law? I don’t even care about insurance right now. I just don’t want to mess with an unknown in the middle of a health crisis. The pharmacy I went to is good at least so I may have help there.
On another note, one thing my doctor has done for me in the past with other drugs is specify a brand for a generic, like PAR for Wellbutrin XL AND write DAW in the box because the pharmacy I have to use refused to be consistent with at least Bupropion vs. Budeprion when asked and even would substitute Budeprion when Bupropion was on the Rx instead of Wellbutrin.
I don’t know what the right name is for generic Concerta but this looked like Bupropion HCL XL (dose), PAR brand with DAW in the box for Wellbutrin XL and it works at the pharmacy my insurance requires after pharmacist grumbling and with my insurance for the generic copay. Writing in the format [generic name of drug], XXX generic brand, then DAW in the box has worked for me with many drugs when I need a specific generic and I only pay my generic copay. A large pharmacy with poor customer service seems forced to fill exactly what was written (the mom and pop places often do it because you ask but I only get a fill or two with them). The brand specified is generic, so my copay ends up being the generic copay. I hope this helps someone else. I am going to ask for Watson this way next month and hope it works.
I know something like this was mentioned in the blog post but it was more like reuest that brand of generic and cross your fingers or pay for brand name. But one of my doctors figured out the magic combo of exactly how to try and force the issue when the request is met with “no” and it really does matter (like my dose is different for different generics and I just need to keep getting the same one, not necessarily needing the brand) and tbis works for me at least and my other doctors use it too now so I thought I’d share. It really came about because I needed at least the same chemical with Wellbutrin and a specific pill shape with another drug but I think it would work with Concerta too so I can get the same brand of generic I’ve been taking.
Is consistency really too much to ask for? And why does the law not allow me to request a subset of what was prescribed and have that honored? I’m lucky my doctors understand about generics and will prescribe me EXACTLY what I need. I’m also worried that Watson will come up with their own generic and not use OROS as well at some point and I will be stuck paying for brand for yet another medication because the generic really isn’t the same.
But my most immediate concern is these pills I ended up with. Have the Mallinckrodt pills worked for ANYONE? And interactions are a concern as well too. I did subscribe to the blog but haven’t clicked around yet and maybe this is answered somewhere else. Or maybe if there is no way to find out if these pills are entericly coated before I run out of Watson pills, it’s enough reason for me to be able to get new pills. I don’t know the specifics of the new controlled substance law, just that life was hard enough with the old one. It’s not like I can just choose to pay out of pocket and get what I need here. There are laws not doing anything to stop drug abuse in the way putting my health at risk…
So if anyone has anything GOOD to say about the Mallinckrodt pills, I’d like to hear it. And if anyone is also using Concerta for one of its other FDA approved uses in addition to ADHD, I’m interested in how well the Mallinckrodt pills work for that stuff too.
Thanks
Danielle
Hi Danielle,
I can answer one of your questions: “On another note, one thing my doctor has done for me in the past with other drugs is specify a brand for a generic, like PAR for Wellbutrin XL AND….”
As I wrote in my last post (yesterday), yes, your physician can specify that the Rx be filled with the Watson generic (which is the same as brand). This licensing agreement ends, however, sometime next year.
https://adhdrollercoaster.org/adhd-medication/concerta-generics-dealing-with-the-pharmacy/
best
g
P.S. Danielle, you wrote:
I’m also worried that Watson will come up with their own generic and not use OROS as well at some point and I will be stuck paying for brand for yet another medication because the generic really isn’t the same.
That is exactly what will happen. This marketing agreement was negotiated between Watson and Janssen (Concerta’s manufacturer) when Watson agreed to delay introducing its own generic in exchange for Janssen allowing Watson to distribute brand as generic.
g
Folks, please be sure to subscribe to my blog so you receive updates on this issue. It’s an evolving story.
Gina
G! I am in disbelief… To whatever happened. I know my body, I have adult ADHD, I just picked up Mallinckodt methylphenidate ER for SR!! THIS IS INHUMANE! It is similar (or was similar) to an IR = Instant Release) It worked wonders for ME! I was outgoing, motivated, and HAPPY! If the Rx (med) did it’s job why, am I feeling depressed! Something is not right with the mallinckrodt SR. Labelled ER generic for Ritalin SR… NOW, I have had a flushed face known as ROSETIA, and the inability to focus on anything or anyone! ?? I have a form of MS. TMS, since treated with MY ATTENTION DEFICIT DISORDER, I completely turned my life around! I’m 33 going back to school now on my 5th semester, now broke through to obtain a job in Rx, pharm tech. I also, cognitively learned to run, “literally”… So, I can go work on my cardio at “Planet Fitness” the only issue, or wall, to overcome is being labeled as disabled from low income housing, waiting for or trying to change this. Staying at my folk’s is turning to be the clincher! They see me more calm and happy, not chatty and not saying words before thinking rationally and to them they don’t like it as “I seem doped up?” According to them. My mother and father should see what’s been a MAJOR FACTOR IN MY LIFE! SINCERELY, Looking for a new med! ; )
Hi Gry,
I’m having a bit of a hard time following you.
So, you’d been taking brand Concerta, and it had helped you turn your life around.
Now, you just picked up your prescription, and it is the Mallinckroct generic of Concerta?
Do I have that right?
Please see this later post: http://wp.me/p5Ilzb-10w
Look for this question: Q 12. “Argh! My pharmacy is still substituting the downgraded generics for my Concerta prescription? Isn’t that illegal? What can I do?”
Note this part of the answer, where I instruct readers to download this report from the FDA
Bring it to your pharmacy. Tell the pharmacy that it has acted illegally in substituting this downgraded generic for Concerta.
There is another option: The Actavis (OROS) generic, which is the same as brand but marketed as a generic.
Ask for it!
Good luck!
g
Hi Gina
My son is on 54 mg of the Mallinckrodt generic of concerta. Shaped totally different and I don’t understand how it can be time released cause I see no hole. Do you know how it works then? He won’t be on it very long because I called the drs today to let them know this generic is deft not working for him and has actually made things worse. Poor kid ant even focus in school and he thinks he isn’t doing his work correctly. Never has he had a issue with school work he has always been a straight A student! I blame this on the generic not doing what it is suppose to. Dr is going to write on his script NO GENERICS. Hope Medicaid accepts this.
Hi Cathi,
There are various ways to deliver a medication in a time-release fashion. OROS (the pump with Concerta) is not the only way. But it is the key difference between Concerta and, for example, Ritalin. Same medication, delivered in a very different way.
With all of the modern medication choices for ADHD, the main difference is the delivery system. The medications they contain are actually quite old (and, fortunately, well studied). But the delivery system can make all the difference for a person. Someone who can’t tolerate Ritalin can do well on Concerta or Daytrana (the patch), and vice-versa.
More choices have been a boon for ADHD treatment. The generics now pose to turn back the clock on progress.
Gina
I had a problem with the kremers brand. I ended up in the ER with a migraine accpanied by continuous vomiting 5 hours after I had taken it. I have taken the non generic for almost 10 years with little to no problems
Susie — Holy cow!!!
I hope that you filed a MedWatch complaint. Please let know if you need the link.
I think I need to post again on that, with a step-by-step.
g
I understood concerta to be like Ritalin with a different delivery system (psychiatrist said it’s smoother and more reliable). Do we have any information on the true generics deliver system? My pills still say Alza, so I am probably safe until 2014 but it looks like this is probably something coming down the road. Seems like these true generics should be a product in of themselves.
Hi Andrew,
Well, generics are a product in and of themselves: they’re generics, not brand. And there is a certain variability allowed with generics. So, right off the bat, we know that the generic will be different than the brand.
Concerta contains methylphenidate, the medication that is Ritalin. It is the delivery system that makes all the difference. So, some people that can’t tolerate Ritalin do well on Concerta. And, in some cases, vice versa.
As for the Mallinckrodt generic of Concerta, I had to file a Freedom of Information Act request to see the data on how its profile compares to Concerta. Otherwise, it’s considered a “trade secret.”
But we know that the OROS osmotic pump that makes Concerta Concerta is not used. Without a similarly sophisticated system, it is unlikely the profile will be closely similar.
I will be posting more detailed information, explaining what I mean by a medication’s profile and offering illustrations.
Please subscribe to the blog to be notified when that post is up.
Gina
I have the same problem with Mallinkrap “ritalin.” I have to take 3 of the 20mg SRs to get the necessary dosage instead of the 2 I normally take.
They make the cheapest ones, so all the pharmacies stock them out here in Oregon. and you can’t tell your mailorder insurance provider not to send them.
I recently switched to generic Lexapro to get away from Mallinkrap. Unfortunately, there’s not a generic time-release version available yet, so my doc has to fight with the insurance to get them to cover the brand item.
I’m also bipolar and sometimes when I’ve complained about this in the past, I get accused of being manic!
Virginia,
Whoever said that to you is woefully misinformed. That is so out of line. Argh.
g
I meant to say generic Focalin. I’ve only been taking it a few days and I really love it. Remembering to keep taking it isn’t hard, I just stand there and realize I don’t know what I’m supposed to be doing, and then I take another pill!
🙂
Gina,
Excellent info, certainly needs to be posted, will send out a post soon w links to all of these helpful reports.
Press on!
Chuck
Thanks, Chuck.
g
Thank you for this thorough information. I will be on the lookout now. I really hate the way the wool has been pulled over our eyes regarding generics.
Me, too, Marie. At least the pharmacists should be honest with us. So much depends on these medications working as we’ve grown accustomed to.
Gina, thank you for this very informative post. Mallinckrodt also markets 36 mg and 54 mg as my family has received both M36s and M54s from Costco. My records indicate Costco’s generic Concerta manufacturer changed from “Watson Labs” to “M’ckrodt Spec” in May. We have noticed a significant decrease in effectiveness since then which can now be explained. We will be shopping around to obtain the Watson authorized generic going forward.
Thanks Susan. The FDA just this morning told me the Mallinckrodt was approved only for the 27 mg. Thanks for correcting that info.
g
Gina,
For about the last two to three weeks I have been totally off…tired etc. I couldn’t put my finger on it. I just knew things were not right. I didn’t put the pieces together until I read this. THEY CHANGED MY PRESCRIPTION WITHOUT MY KNOWLEDGE!!! I have been on the Watson’s Concerts with their OROS delivery system ever since Concerta went generic. I have been on Concerta since it came out. Well when I filled my last prescription….it is by mail….they decided to fill it with the cheaper Mallinckrodt….which by the way does make a 54 M because it is marked right on my pills. When I mentioned this to Marty he even told me that for the past two weeks he has noticed he has had to finish sentences for me because I just stop mid sentence and I am done. So with starting a new job this is NOT a good thing. I don’t know what I am going to do because this is a new prescription and it is NOT working. Any suggestions? Can you email me?
Thanks,
Katherine
Hi Katherine,
Did you read to the end of the post? There are a few suggestions there.
g
I feel like such the fool, as it has taken me almost 9 months to figure this out. By all appearances I should have been at the first wave of complaint. I am a physician, indeed a sub-specialty trained surgeon with a practice based upon tertiary-referral complexity level cases. When I was first involuntarily switched to the Mallinckrodt generic (UHC-OptumRx), I now recall that I thought I must call my prescribing physician to ask if any others had reported the remarkably irregular and apparently unpredictably “spastic” nature of the delivery of the drug! Soon this was overshadowed by a host of other complaints, of which I am hesitant to disclose, lest you think-as I thought-that I had turned into one of those crocks that simply reported YES to every possible symptom. One thing led to another, until by the grace of God I was finally compelled after a space of time to see the prescribing physician, who casually reported the common knowledge of the poor quality and irregular delivery system of this “equivalent”. I was still relatively suspicious of my “crock”-ness (crazy patient with host of unreasonable and illogically connected complaints), but was happy to return to the previously steadily effective drug delivery that had offered me such steady support of function over many years.
The result is almost beyond decription that language can impart. As a physician/scientist I know that the strongest medication/intervention is the placebo effect. That said, and even if that be the only truth explaining my experience, the change in me has been dramatic, and this change occurred in TWO DAYS/doses! Prior, I would have said that I could not even remember feeling good, and was beyond weary of not only my litany of complaints, but also of even ME. It was less than 2 weeks ago that I was writing my last will and testament, feeling that if my life was this and this only, it should end. I AM BACK! Over the past months a challenging surgical case, which had previously offering me great joy in solvingand overcoming its complex obstacles, now was a series of searingly painful tortures I endured, praying that I would/could avoid harming the patient in the process. In reflection, the product experienced by the patient was likely not much different (God bless anesthesia!). The process was clearly much more toxic to anyone else present and awake, including me. After changing back to “alta” on Wednesday morning, today (Friday) I did a 6 hour grueling, complex, frustrating, and JOYFUL case. I did not regret being ME as I did it. I did not feel like anyone who endured ME in the process deserved an eternal crown of glory previously reserved for the martyrs. I am back! I regret my absence, and regret the pain I know my presence has inflicted while I was fighting to return.
Dear Arizona Surgeon,
THANK YOU for your eloquent narrative. Don’t feel foolish. You were duped. As were so many people.
I am compiling all of these comments into one dramatic blog post. Stay tuned.
I’m still outraged. But glad you are back and happily doing your work!
Gina
Lol. I read to the end of the thread , only with the help of (and thank goodness) the right generic adhd medication
So, when i came across this thread in researching and found the response to
Katherines post on feeling off and medication Is just not working etc. Then Gina you reply asking if she read to the end of the post because there are some suggestions there …
I was thinking in Katherine’s defense, because i have been in those shoes, heck no couldnt read to the end of the post, because the new generic is not working.
This is the other part in which adhd therapy cannot be done simply by taking medication.
Hi Carrie,
HA! I can see how that sounded. I wasn’t trying to shame my friend Katherine into reading more tedium. Goodness knows she did enough of that in earning her PhD. 😉
I was just trying to point her to what might be useful information.
thanks for the laugh,
g