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.
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.
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