Several comments to my previous post on the new Concerta generic (made available only in the U.S., not Canada) suggest that this “authorized generic” might not be exactly the same as the brand name, as claimed by the manufacturer. Then again, a news report this morning leaves me wondering if some people have received counterfeit pharmaceuticals.
A recap from the previous post:
The U.S. generic for Concerta is methylphenidate hydrochloride extended-release tablets. It is a co-licensed product by exclusive agreement — that is, a deal between the original manufacturer (Ortho-McNeil) and the pharmaceutical marketing arm of Watson Laboratories.
Both brand-name Concerta and the so-called “authorized generic” are manufactured in the same plant, said the Ortho-McNeil spokesperson by phone. And, this authorized generic is both bioequivalent and clinically equivalent. Does that mean it’s the exact same medication? I think so, but I cannot be absolutely sure at this point.
This morning, the California Report’s Sarah Varney explained a California law designed to protect consumers from counterfeit medications (the law has been fought by trade groups for years):
A state law meant to thwart counterfeit prescription drugs is finally set to go into effect 16 years after it first passed. The electronic tracking system will make business harder for those who sell fake drugs. (Listen to this short report here.)
I’ve found no data documenting counterfeit problems with the more expensive stimulant medications (Concerta, Vyvanse, etc.). And readers’ comments offer no details on where the medication was purchased. Stay tuned. And please share any tidbits you learn.
-
Glad to see a rethink on this. fwiw, i get my generic (and all rx) at CVS (massachusetts).
btw – my generic looks EXACTLY like your “alza 54″ pic on the original post, even under a magnifying glass it’s flawless. If it’s counterfeit, they’re pretty sophisticated. Also (thinking like a criminal): if I were going to counterfeit this drug for profit, I’d pass it off as genuine Concerta rather than the cheaper generic since no-one could tell the difference.
I think you’re right to scrutinize the drug co’s statement. I’m also not convinced that the generic is even intended to be absolutely identical to Concerta, tho terms like “authorized generic” and “bioequivalent” are perhaps used to cleverly imply that they are. I won’t believe it until I hear a legally-binding, unqualified statement (from Watson or Ortho-McNeil), for the record, saying that “Watson’s generic IS brand-name Concerta, right off the Concerta assembly line, period.”.
(Sorry I’m a huge skeptic).Thanks for keeping an eye on this topic, I hope it prompts someone to do a proper investigation.
-
Hi Cookie, and thanks.
I’ve asked some scientist friends who’ve worked at pharmaceutical companies about this, and they are skeptical that Ortho-McNeil would create another manufacturing process for this “generic.” It’s just too costly.
Meanwhile, I’m wondering who is even monitoring reports of medications not working. I know you can file a complaint with the CPA if, for example, laundry detergent gives you hives. But I don’t know about medications.
If California had to fight for 16 years to get this law in effect, there seem to be powerful forces against any kind of monitoring. Makes no sense to me that pharma trade groups would oppose this, as counterfeits cut into their profits.
tx
g
-
-
Thanks for staying up on medication issues such as these Gina.
-
I am reading this post because my son seems better on Concerta 18 than Concerta 27. We recently increased for school but continue to give him 18 on the weekends. I am wondering whether the 27mg is bio-different or even counterfeit.
Oh, how I hate ADHD!
-
Dave — Of course simpler explanations include these:
1. the 18 mg is the best dosage for your son.
2. It could be that he has co-existing anxiety, and the higher stimulant dosage exacerbates it. If it’s the latter, you should talk to the doctor about treating the anxiety as well.Good luck sorting it out.
Gina
-
-
Thank you for this post. However, I still have my suspicions. My 20 yr old son has been on Concerta for about 8 years and has not had any problems until this year (junior) year in college. He is on 72 mg (max) daily, but his behavior is like he is not on Concerta or a a very low dose. His ADD is more distractible with inattention than impulsivity. He has always been a straight arrow so I am not concerned with drug abuse or alcohol. He is just doing things like turning papers in late that we haven’t seen him do since elementary school. The recent nationwide shortage also has made me suspicious too.
-
Hi Dee,
Maybe something else has changed for him? Perhaps a different living situation? Different friends? Different diet or exercise? Or, perhaps, the courseload is heavier or more complex?
I would look at the latter first.
good luck!
g
-
-
Courseload is heavier–but his behavior is like he is in the 5th grade. He is generally an upbeat person, pleasant and that has not changed. Judgement, inattention. Such as turning in a finished paper by putting it on a chair in the hallway of a professor’s office. I know that Concerta works by osmolarity so how can Ortho create a cheaper delayed release system. Don’t they have to cut corners somewhere to make generic cheaper?
-
Dee, I made further calls to both McNeil and Watson, and I am completely convinced that this “generic” is exactly the same as brand. It IS the brand.
And no, they don’t have to cut corners to make the generic cheaper. This is what happens in the U.S. when medications go off patent. Read my previous posts for the nature of the marketing agreement with Watson.
-
-
Thank you for investigating this. You are very kind. Thanks again.
-
You’re welcome, Dee. I do my best.
g
-
11 comments
Comments feed for this article
Trackback link: http://adhdrollercoaster.org/adhd-in-the-news/update-on-generic-concerta-counterfeits/trackback/