Janssen Quietly Ends Concerta Authorized-Generic

Janssen Ends Concerta Authorized-Generic

Concerta manufacturer Janssen ends availability of its authorized-generic  mid-January 2023. Shocking, I know.

What does this mean for consumers who have relied on this ADHD stimulant medication for years?  That likely depends on personal resources, insurance pharmacy benefit terms, and other factors. Right now, I just wanted to give you a heads up—because Janssen sure didn’t.

Try not to panic!  Instead, use this time to gather information and get your ducks in a row.  It’s tricky this time of year, always, as stimulant raw materials run low. (The Drug Enforcement Agency limits supply, and I’m not sure it’s upped the limit since the COVID-driven high rates of diagnosis and teratment.)

Want to share a message with company executives?  Please leave a comment.

I did speak with a Patriot representative who confirmed that the authorized-generic for Concerta ends January 13. To find more details, I made multiple phone calls to multiple offices at Janssen and parent company Johnson & Johnson. No response. (Companies don’t have to respond anymore. That went out with the flood.)

I’ve been covering Concerta and its generics since 2014. You can read a historical overview here: Generic ADHD Medications: Events In the News 2009 to 2022

Meanwhile, Consider These Tips

I’ve assembled a few suggestions here.

But know that much might change come January 13, when the authorized-generic is officially discontinued.  Also, it might be that your insurance pharmacy benefit has changed if it follows a calendar year.

  • Check your pharmacy benefit to see if you can get brand Concerta—at what price and what is your out-of-pocket maximum.
  • Have you already tried an inferior Concerta generic, to bad effect? Start documenting that with dates and details for possible “pre-authorization” or “medical coverage exception”. Summarized in a letter from your prescriber, this might result in your insurance covering brand.
  • Check to see if the Concerta savings coupon will work with your insurance (not available in CA and MA)
  • Don’t wait until the last minute to fill your prescription! As I mentioned, stimulant raw materials (limited by the DEA) typically run out in December anyway. This year supplies seem extra-stretched.
  • Start trying methylphenidate alternatives, if you can (I recently shared this updated post: Liquid and Chew “Ritalin”: Quillivant XR & Quillichew XR.  And, I share important medication details in Course 2: Physical Strategies)
  • Call your pharmacy benefits manager (or check the website) to see which ADHD medications are covered, as generic or brand. This is typically called the formulary.
  • If a stimulant in the amphetamine class has never been tried, this might be a good time for it. While prescribers have been trained by sales reps to automatically choose Adderall first, there is no evidence for it. Moreover, it has the highest side-effect profile among the stimulants.  Vyvanse might be a better choice, at least to start.

The Changing Concerta Landscape

In the past, consumers could more easily switch to brand Concerta. They’d pay the brand price, of course.  Yet, depending on insurance coverage, it would be maybe 3-5 times the generic price. That is, more like $100/month, not $600/month. Even less with the home-delivery 90-day pharmacies.

Then everything changed. Beginning in 2017, “Big Generic” unleashed a slew of non-bioequivalent Concerta generics. Many are produced for pennies, some in poorly regulated Indian and Chinese factories. If your insurance coverage specifies generic (if available), that’s what you might get.

Even with insurance coverage that previously covered brand, soon that wasn’t an option, at any price.

Fortunately, Janssen continued to make available its Concerta authorized-generic.  With a bit of effort—and guidance found on this blog—many consumers were able to get brand Concerta at a generic price. But insurance companies and pharmacies paid a higher price, compared to the inferior generics.

Concerta Users Have Been Lucky Thus Far

In a very real sense, we’ve been fortunate to have had the Concerta authorized-generic (brand sold as a generic) for so long. It seems unprecedented.

This is partly due to Concerta’s sophisticated delivery system, using a proprietary osmotic pump called OROS from Alza.  Without OROS, Concerta generics are basically Ritalin generics.

That’s why the FDA downgraded the first two inferior Concerta generics, thanks in large part to ADHD Roller Coaster readers filing MedWatch complaints. They just didn’t work the same as Concerta does.

Things changed in 2017 when the Trump-appointed FDA chief over-ruled FDA scientists concerns about regular Concerta generics’ bioequivalence.  Next thing we know: A leaky boatload of junk generics.  (Yes, some work better than Concerta for some people. That’s not the point. The point is that they are not bioequivalent, and that’s the basis for generic status.)

Janssen Gave Consumers No Notice

Did this earth-shaking news come in a formal announcement from Johnson & Johnson, parent company to Janssen? How about an obscurely placed press release? No. Apparently, the company that has reaped billions from consumers choosing Concerta didn’t find them worth that little courtesy.

By the way, it’s not like Janssen’s been performing a charity with Concerta. Sales are up 19%, in the U.S., according to Johnson & Johnson’s third-quarter 2022 results.

Johnson & Johnson Reports Q3 2022 Results, concerta profits

Sure, we’re grateful to have gotten the authorized-generic for this long. And we understand that other factors precipitated this change. But that doesn’t mean we overlook having no notice of this change. No press releases. No nothing.

Rather, three alert ADHD Roller Coaster readers gave me the heads-up yesterday. They reported unsuccessful attempts to get their current prescription filled. Upon calling Janssen’s authorized-generic subsidiary, Patriot, they got the news.

Shortly after, I called Patriot. The representative tried to be helpful but had few details.  Bottom line: Yes, the Concerta authorized generic will cease availability January 13, 2023.

Multiple efforts to get more details today from Janssen  or J&J have failed.  Apparently, company executives find it a trivial matter—metaphorically dropping on their heads customers loyal to Concerta for decades.

One Timely Factor: Open Enrollment

Many people this week (Nov 4, 2022) are going through “open enrollment” for employer benefits. That’s why I am rushing this with few other details, in case it helps with the decision-making.

Please Leave A Comment for J&J Executives

Johnson & Johnson Executives Authorized-generic Concerta

My Comprehensive Post on Concerta Generics

You’ll find my main post on Concerta Generics here:  Authorized-Authorized-Generic Concerta Update

98 thoughts on “Janssen Quietly Ends Concerta Authorized-Generic”

  1. Does anyone know if Vyvanse might be a good alternative for someone who has taken Concerta for years. Also, do you know if generics of Vyvanse work as well as the name brand? Is Vyvanse cheaper than Concerta?

    1. Hi Mike,

      i appreciate your questions. I would caution, though, about asking random strangers—even those discerning enough to read my blog. 🙂

      ADHD medication is a serious issue, much too serious to leave to change. Right now, I hear, ADHD Reddit indicates that the Trigen generic for Concerta uses OROS. It does not. It uses basic osmotic technology.

      To your questions, I encourage you to read my first book:

      Is It You, Me, or Adult A.D.D.: Stopping the Roller Coaster When Someone You Love Has Attention Deficit Disorder https://a.co/d/ixYuS34

      I explain why you should try both classes of stimulants — and why one might clearly work better than another for you.

      There is no generic for Vyvanse….yet.

      As to whether Vyvanse is cheaper than Concerta, it’s impossible to compare without knowing the specifications of your insurance pharmacy benefit. I’m assuming you aren’t paying case because both would be extremely expensive.

      Cheers
      Gina

  2. I doubt this is news to you, but have read that “Camber” uses OROS technology and seems to be liked by most versus other generics. This info came from a reddit thread, but it quotes a reply to an email from someone at Camber. I can’t copy and paste but ” Camber’s generic Concerta uses OROS technology” would be a search that would lead you to it. I’m hoping this is true and might help someone out there on one that’s not working. Thank you so much for your efforts.

    1. Hi Frank,

      Thanks for reporting in! 🙂

      Unfortunately, many online discussions veer off into misinformation. Come here for the facts.

      Camber does NOT use OROS. It uses an osmotic technology but not Alza’s proprietary, sophisticated OROS. Camber’s is a more rudimentary mechanism.

      I’ve heard more than one pharmacist insist that Camber’s is OROS. It is not. This is clearly the work of aggressive marketing. And it’s a shame.

      I don’t believe anything I read in pharma ads. I check the data.

      cheers
      g

  3. Thank you so much for this info. I found you via a Facebook comment and now realize you are the person behind the blog that led me to Actavis and then Patriot in the first place. Thank you for all of your hard work.
    My youngest has been on generic concerta for about 10 years and says the other generics don’t work for them as well as authorized. I’m hopeful, with your advice and the comments from other readers, that they can find something that will continue to help.

    Man- this sucks a lot.

    1. Hi Thea,

      Yep, that’s me!

      And yep, it does suck a lot. I am remaining hopeful that Janssen will make it more affordable as a brand.

      g

  4. Dear J&J execs. No. Please. No.
    I pay my taxes. I vote. I am a good person. I never cheat or take shortcuts. I work hard. I’m a good mom. I’m a good wife. I look after my mother who has a degenerative brain disease.
    I cannot do any of these things without my correct medication. I have ADHD. My kids both have ADHD.
    I tried the generic and I was literally sick for that entire month. Some days I couldn’t even think of the words I wanted to say. I posted in Gina’s ‘authorized generic’ blog back then and it was a dark time.
    I am just in tears right now, and will be praying tonight for my family and all the other families. The ONE pharmacy that has been filling the Patriot ‘brand’ for us, just told me this was the last one.
    Why is this happening? How is this okay? Is there really nothing that can be done to make a permanent change? How is Concerta so much harder to get than anything else – even my mom’s brain medication is easier than this!
    Please don’t let this legacy of suffering continue.

    1. Thank you, Vicky, for leaving that powerful message.

      I’m hoping that Janssen re-jiggers some deals so that brand Concerta is more affordable attained.

      Trump’s FDA chief created this mess. This gift to “Big Generic.”

      May they hoist themselves on their own petard.

      Take care
      G

  5. Gina! Wow, this is an amazing site and it’s the most helpful!!!

    Last month I started Concerta generic 18mg ER OSM TABLETS mfg Actavis from Walgreens. No major side effects (some dry mouth) minus the first two days of headaches and a clenched jaw by hour 5 on both days. As day 3-5 went on it already felt better.

    By week 3, I didn’t feel as productive or as focused and still had mind chatter but was productive in tasks, feeling better and hopeful and excited etc. Motivated.

    Yesterday, my doc upped to 36 mg which is fine as 5 day/ I accidentally took two 18s in the hour and got worried it would be too much, but it seemed fine! I told my doctor and he said it would be fine since it’s been three weeks or so.

    Anyway, I called around to get these 36mg Concerta generic and it was OUT EVERYWHERE! I called some 15 pharmacys around the valley for what they had in stock. Nothing.

    Until a CVS nearby had it! So I said yes. I had my pharmacy location changed and picked it up this morning. I took it at 8:10 and felt nothing. Until I did.

    Woah, what a difference. I kept waiting to “be focused,” or “motivated,” or even happy. Wait happy? I feel unhappy? I did. Annoyed and slight anxious. I felt a bit depressed but mixed with boredom and not sure why… An overall irritation (at nothing) in particular, and was aware of it. I simply got NOTHING DONE TODAY, other than reading about this drug and calling more pharmacists, insurance, and trying to get a hold of my doctor for 24 hours.

    Anyway, I came across your wonderful site and realized it must be this CVS TRIGEN generic. Omg I didn’t like it all. I was yawning through my day, sleepy, sluggish, and again annoyed, unexcited and bored.

    This is my day off from working and I was excited to bake and holiday prep and get things done and instead I’ve been laying in bed and the couch.

    Your article helped me realize they are NOT all created equal and I don’t want this.

    On the bright side, happy I chose Walgreens first, bc if I had tried CVS I would have ruled Concerta out all together so that’s a plus.

    Anyway. I am new to meds all together. I know I will not take the CVS ones. I almost thought I’d try one more day but after reading it seems like I can just TRUST MYSELF , BODY AND FEELINGS.

    I called the Walgreens Pharmacy and they have my old script of 18mg so I called back to my doc and left another message asking can my prescription be changed to 60 18mg. They said they’d get back to me, but I heard that yesterday.

    So, I made an appointment for his first available Monday, a full week from now. But better than nothing.

    Thanks for your site and clarification. I have much reading to do. Thanks for answering Blake’s question about the Concerta Coupon bc I’ve asked many Doc’s, pharmacy’s, tried calling insurance and nobody could help.

    I’d like to try Concerta for $4 but my Cigna plan doesn’t cover name brand Concerta. So at least I had ONE question of many, answered by you!!! Thank you!!!

    QUESTION FOR YOU:
    I read Actavis was no longer but that is my mfg. Does that mean Walgreens will switch these come Jan? Mine has a triangle on it with 725 and doesn’t look like that odd shaped , rounded yet strait edged Jannsen that I think is being discontinued as of Jan 2023.

    Just curious as I’d like to get ahead of this all for the holidays and next year.

    Also, wherever I can put my notes for TRIGEN I will. I have been using the Daily Bean app to track extensively moods, feelings, actions and a timed journal (I used to be a research analyst so I love data). Lol

    Anyway, so glad I took notes for myself bc Walgreens Concerta vs CVS is awful.

    If I wasn’t off work today, I’d be a mess trying to be around people, do my job and be kind. In fact, this TRIGEN brand is worse than being in nothing. This shouldn’t be legal.

    Thanks again!! Any help clarifying what exactly I’m taking is helpful as I’m overwhelmed with all the pharmaceutical company buy outs and what is what and what I’m taking and what is being discontinued! Have a great week and Happy Holidays!

    1. Hi KQ.

      I’m glad you found my post, too!

      And good for you, to navigating this Hot Mess.

      re: Actavis…..you might be thinking of the OLD Actavis. Actavis used to distribute the brand Concerta as an authorized-generic. So, folks got used to calling it the Actavis generic, even though Actavis had nothing to do with it. It was just a marketing deal to forestall the Actavis generic entering the market.

      Many years later, Actavis was purchased by Teva, which introduced the Actavis Concerta generic. With me so far?

      So…OLD Actavis Concerta generic….brand distributed as generic (authorized generic)
      NEW Actavis Concerta generic….its own generic, lacking Concerta’s key delivery system, Alza’s OROS.

      CVS, in my experience, is the worse. Since it was allowed to buy Aetna a few years ago, in an obscenely priced deal, it’s been a really “bad actor” in general re: Concerta generics.

      Walgreen’s has consistently been a better corporate citizen. But it has its limits.

      Sometimes pharmacies CHANGE generics.

      You could ask Walgreen’s to note on your file — ACTAVIS (or whatever generic you prefer) ONLY. Your doc might specify that on the script/electronic record.

      I can’t say from here, but the fact that you’ve followed all the details and have been tracking your responses….seems like it might be “working” for you. It’s hard to say, though, if you’ve never tried brand Concerta. Might be better. Might be worse!

      Good luck!
      g

    2. Don’t knock other mfg pills because it didn’t work for you! TRIGEN has been a miracle pill for me, but now trying to get it again is proving a nightmare, and the lesser generics aren’t a good fit for me. Everyone is different!

    3. Hi Meg,

      No one is “knocking” a medication just because it wasn’t right for them.

      Rather, people who have used Concerta to good effect should not be stuck with a random generic that in no way resembles Concerta.

      That is the issue — the lack of these generics’ bioequivalence to Concerta.

      If Trigen works for you, great. You are lucky. It does not work well at all for many others. More importantly, it does not work as Concerta works.

      good luck finding what works for you,
      g

  6. This is so depressing.

    Gina, thanks for everything you have done, and continue to do. The service you provide is priceless.

    Does anyone have a generic that they like (other than the Patriot one we all love?

    Or has anyone considered regular Ritalin? I started on that and it was good. When I remembered to take it. :).

    1. Thanks, Blake. I appreciate that.

      You might want to read through the existing comments. Some readers have mentioned their experience with various generics.

      The thing is, what works for them might work for you — or might not.

      As I mentioned in the post, if it were me, I’d be doing a weekend trial of one of the other MPH products, such as the patch (which is now a generic), Quillivant, or Quillichew. Though if one’s insurance policy doesn’t cover brand, the last two might not work.

      good luck!
      g

  7. How can one check if the Concerta savings card works with their insurance? Do we call our insurance company?

    I read the qualifications for the card and don’t fully understand.

    Thanks in advance!

    1. Hi Blake,

      My understanding is this: You bring the prescription to the pharmacy (or your prescriber electronically submits it).

      That’s the only way a pharmacy can tell if it will work with your insurance.

      Other factors that likely mean the card won’t work for you:

      1. Your insurance plan stipulates only generic medication, not brand.
      2. You live in MA or CA.

      For not, until the authorized-generic Concerta distributed by Patriot goes away mid-January, 2023, you might still be able to get it. As a generic, not a brand.

      g

  8. Life altering.

    My wife has tried to get me to brace myself for the day when this would happen. But I just refused to accept it. My quality of life will be affected. Period! And so will all of those around me.

    Will I die? No. Will I be less productive and harder to live with. Yes.

    No amount of medication “games” will fix this. I have what works for me and now that’s done. Sad.

    Thank you for all your work and information over the years. I would have gotten this far without you.

    1. Hi Craig

      You’re most welcome.

      I’m hoping that Janssen has been cutting some deals, to make the brand more affordable.

      And who knows, maybe the patch or other would work for you.

      Maybe you can get a trial of it now.

      Take care,
      G

    2. Doesn’t all of this- authorized generic and brand- come off the same production line? If one is ceasing, aren’t both?

      And even if that’s not the case, trying to get brand is a real goose chase. Tried to get it back at the beginning of the year through the new online pharmacy (OptumRX) that BCBS switched us to. After one cycle, they were out of brand and wouldn’t restock.

      No one local will go through the hassle for one patient. How a manufacturer can justify continuing to produce a medication if no one can access it is beyond me. The way forward was to at least make available a reduced cost version like the one we had. That had the possibility of retaining market share if priced properly.

      People who knew what made it special would have gone out of their way to obtain it.

    3. Hi Craig,

      If you’d like answers to your questions, it’s all here:

      https://adhdrollercoaster.org/adhd-medications/authorized-generic-concerta-update/

      Bottom line: The Trump White House appointed an FDA chief that overrode FDA scientists’ objections and pushed through a slew of these junk generics for Concerta.

      Janssen had made the authorized-generic available for many years. But when these pennies-to-produce junk generics flooded the market, it could no longer compete.

      No, the authorized-generic is discontinued but the brand continues. They are the SAME. The AG was just marketed as a generic.
      g

    4. Yes, I’ve kept up on the madness over the years based on your reporting. Quite aware of the low price situation as it relates to the garbage generics from the other companies.

      My point was that there had to be a price point that could still make the authorized generic viable for the manufacturer.

      The only thing I was unclear about was whether the name brand was still being produced. Is that being done at a separate location? Or on the same production line with it only being designated for name brand distribution?

      I can’t see how that is at all sustainable for said manufacturer. No insurer in their right mind can be paying for that. And there can’t enough people paying out of pocket to keep production profitable.

      Even if they are still producing it for name brand distribution, the real question is for how long? This ship has sailed and we’re all screwed.

      Enjoy your day. I’m going to call my doctor for an appointment to review my options. Then I’m going to start drinking heavily. Cheers!

    5. Hi again, Craig,

      As I wrote in response: No, the authorized-generic is discontinued but the brand continues. They are the SAME. The AG was just marketed as a generic.

      We don’t know what the price will be in January. As I wrote in the post, it might be that Janssen is cutting deals with pharmacies and insurance cos…. we can only wait and see.

      g

    6. Ultimately, you didn’t answer the most important question. Does Janssen have its own production line?

      If so, then we shall see. I’m not hopeful.

      The landscape is littered with examples of pharma companies pulling a bait and switch when it comes to medications. See Drixoral.

      As for your reference to National. Do you mean the online site for the pharmacy out of the UK? Dubious at best. Where are they getting there supply? Exactly!

      You are a great advocate and a wonderful resource for those struggling through the morass that is this shit show. But rainbows and sunshine aren’t going to fix this insanity. Or get me my medicine. Good luck.

    7. Craig,

      I have answered your question TWICE. lol! It is in EVERY blog post I’ve written on Concerta.

      BRAND=AUTHORIZED-GENERIC is the SAME THING. SAME PRODUCTION. The brand is only MARKETED as a generic.

      “Rainbows and sunshine”? That’s what you think I offer?

      I’ve guided people through the labyrinth for SIX years. I succeeded in getting the FDA to downgrade the first two generics.

      With no industry support whatsoever. See who else in ADHD online can make that claim.

      In this post, I suggest to start trying other MPH products, now.

      Not sure what more you could ask of me.
      g

  9. Just a thought for trying to get a create a groundswell of feedback that will be visible to the company and others – how about Twitter? I don’t have an account but might consider getting one for this. Gina – would @JanssenUS be the right handle to direct it at? Should we use/create a specific hashtag, such as #JanssenConcerta?

    On a separate note, if the patent has expired, why doesn’t another of the generic manufacturers produce the exact osmotic-pump technology already, regardless of Janssen’s blessing?

    1. Hi Kristi,

      I’m off Twitter. Never liked it. Definitely don’t like it now. But you’re free to give it a go.

      I can’t say for sure about the patent, but it’s probably safe to say Big Generic is too dang cheap to fork over the dough for Alza’s proprietary system.

      Alza might have a deal of exclusivity with Janssen, too.

      g

  10. I’ve been waiting 2 months to get my rx filled and have switched pharmacies twice. Yesterday, I asked Costco pharmacy to price out branded concerta, since I have met my deductible for the year. The prescription in question is for 36mg twice a day for 90 days (which normally costs me $300 before my deductible is met and $30 after it’s met). I was told my insurance will only grand a 30 day supply and the cost would be over $500 for Branded Concerta. Mind you, I have met my deductible. This has to be an error. There is no way the out of pocket price is $5,000. Also confused why they would limit quantity just because it’s branded. I took my chances and filled my rx for the Tigren generic. Has anyone had success with another branded generic? Please share. I may switch to Ritalin la if this doesn’t work

  11. My 19 year old son has tried all forms of methylphenidate over the course of his childhood. Concerta was the only medication that worked for him due to the OROS delivery system. He has been diagnosed with severe ADHD and requires Concerta to perform at a moderate academic level. It has been a huge struggle for the last 7-8 years to find a pharmacy to stock the authorized generic, but we’ve done it. Our insurance is an HMO and will pay for the authorized generic, but has already told us the brand Concerta is not covered. If you remove the authorized generic from the market, he will not be able to take any substitute. My son already struggles with school due to attention deficit, I cannot imagine what he faces with no medication. Please reconsider your decision to cease offering the authorized generic of Concerta to the marketplace.

  12. This is incredibly frustrating for my family considering I have two kids that take this…. Yay, genetics!! Anyway, I’d like to hear experiences from people that have used the savings program. Brand will cost us upwards of $250/30-day supply for each kid with our insurance, but if the coupon program works it could be manageable with a great amount of effort and selling of organs or something. Otherwise, we’re looking for other options that are also dye-free…

    1. Hi Kat,

      We don’t know what will happen to the savings program in January.

      Right now, it works with insurance. So how it works for you depends on the terms of your insurance.

      Maybe just bring it to your pharmacy and see.

      good luck
      g

  13. I’ve been trying to get my Rx filled for over a month! I’m devastated, I’ve been in this medication for over 20 years. Having to take short acting is awful and not the same. I’m a mess and can’t wait to be myself again.

  14. Your website and the guidance you give has been invaluable to me and my son. We learned 2 years ago that my son’s Concerta would not be covered by insurance and that they would only cover a generic version. The first generic was a nightmare and made his ADHD symptoms worse. And then a new prescription couldn’t be written and filled for another 30 days, further making a bad situation worse! With your site, I was able to locate the Patriot brand generic by speaking with a pharmaceutical customer representative. Every 3 months I would go through the stress of making sure the prescription is written correctly by the doctor and speaking with the local pharmacist to ensure the right pills are ordered. To learn that Patriot isn’t going to be making the same generic version available is so disheartening. My insurance only covers generic, with brand name Concerta not eligible for any reimbursement. And a month’s supply of brand name Concerta will be over $800- $1,000 out of pocket according to GoodRX! These kids with ADHD struggle daily with self esteem and work so hard to keep it together. The OROS technology works like magic for some of them and really is life changing. I don’t know many people that can afford $12,000 a year for ADHD medicine. How can this be legal and ethical?

    1. Dear Nora,

      Thanks for sharing your experience. I’m happy to know my work has helped you and your son.

      I am really hoping that, with this change, the brand will become more affordable. Fingers crossed!

      As to your question…how can this be legal and ethical?

      The hard truth is, Concerta went off patent many years ago. It’s only Janssen making the authorized-generic available all this time that many of us have afforded it.

      This is very rare. In fact, I can’t think of another case where this has happened.

      If you were reading in 2014, you saw that we succeeded in lobbying the FDA to downgrade the first two inferior generics. The FDA scientists agreed that they were not “bioequivalent.”

      Then the White House changed occupants, in 2017, and the Trump-appointed FDA chief overruled FDA scientists concerns and pushed through dozens of generics.

      He left shortly after but we are stuck with his stunt.

      Who knows…maybe Janssen would have discontinued the authorized-generic anyway. But this hot mess of junk generics made things so much worse.

      I hope you find something even better—or that we see more affordable access to brand in 2023.
      g

  15. FWIW, I found this:

    “Please be informed that Methylphenidate extended-release tablets manufactured by Ascent employs OROS tri-layer osmotic technology, an advanced drug delivery system similar to the Concerta OROS trilayer technology. The proposed generic drug product resemble to a conventional tablet, comprises an osmotically active, tri-layer inner core coated with a rigid semipermeable cellulose membrane and an outercoat of immediate release drug. The drug delivery is similar to Concerta.”

    1. Hi JR,

      Yeah….no. That’s PR.

      Many of the junk Concerta generics are claiming “osmotic technology.” If you read that closely, it’s full of contradictions.

      What is the source, please?

      tx
      g

  16. Gina, can you suggest which methylphenidate medication has the most similar profile to Concerta, to try first? Assuming I need to change my sons medication, I would like to go to his doctor with a suggestion – that seems to work best in my experience.

    1. Hi Sherry,

      I don’t know. To know the profile for each medication would require even more digging – and as an unpaid advocate who has saved folks $$$$ since 2014 but rarely receives even a $5 donation of “thanks” for this, I don’t have that kind of time. 🙂

      Even then, that would be for the brands only.

      The generics are all faking it, exploiting loopholes in which they claim the same profile.

      Right now, there is an apparent MPH shortage. I’d try for the less well-known Rx, as I suggest in the post. e.g. Quillichew, Quillivant, or the patch.

      good luck,
      g

    2. I understand, I was just hoping you had seen enough to know without the extra digging. Quillichew and Quillivant were at the top of my list. The patch was the first we tried back when my son was in grade school, and it worked well until he needed to increase the dose, then it irritated his skin too much to tolerate it. But, he is older now and that might not be the issue it once was.

      Thanks for all your help. You have been an incredible help through all of this.

    3. Hi Sherry,

      I understand. And I am glad you found my work helpful.

      When we talk about “profiles,” we’re talking about a very specific thing. Measurable. Documented. Part of the FDA approval process.

      So, without digging through all the applications for all the MPH brand drugs, I can’t even hazard a guess.

      Right now, I’d try Quillichew and Quillivant if only because they might be among the few MPH choices available — due to the MPH apparent shortage — that’s not a generic.

      They aren’t well known. Most MDs probably don’t know they exist. I have no idea about how pharmacy benefits might cover them.

      good luck!
      g

    1. Hi Moo,

      Do you mean the current Actavis or the old one?

      If you’ve read my blog since 2014, you’d know that the old Actavis WAS the authorized-generic. That is, it was the brand, with OROS.

      OROS is a super delivery system. These generics are bargain-basement basic. Big Generic exploited FDA loopholes.

      Janssen made that deal with Actavis, to forestall its generic.

      When that deal ran out, Janssen created a subsidiary to sell its authorized-generic (the brand sold as a generic)

      Then Teva bought Actavis and Teva was purchased by Accord, and at least in the UK, it’s unleashed its own inferior generic on the UK ADHD public.

      The NHS tells them with the money they’re saving they can help more people with ADHD.

      Which, frankly, is a crock. I know for a fact that the ADHD “division” or whatever it’s called is sitting on huge sums of money.

      They can’t hire enough staff and people are waiting 4 years for an evaluation.

      g

    2. REALLY?! Clearly, you haven’t been through what many of us have. If it were the same we would not be here nor would we be so upset! Please – no knee-jerk responses.

    3. Why this obsession with leaving unhelpful comments on a post where you obviously don’t even need to be? Oh hey, I’m happy on Actavis, let me Google about how the generic Concerta affects other people and dump my luck in life all over those people.
      Sometimes, you just have to put down the mouse and step away from the keyboard. Real people here are suffering. Actavis works just as well? Well good for you and bye. The rest of us here rely on Gina’s blog for our survival. So find another blog to dump your one liners at. Urgh!!!! I can’t even!
      PS: Gina, this year at Thanksgiving YOU will be what I’m thankful for.

    1. I guess it’s worth a shot, Brendan, but as the person who led the successful effort to have the FDA downgrade the first two generics….I can’t see it happening.

      https://adhdrollercoaster.org/tools-and-strategies/victory-concerta-generics-downgraded/

      Trump’s lackey opened the barn door for Big Generic. He’s back to the American Enterprise Institute, but these junk Concerta generics won’t go back in the barn. Too many of them, and they are all entrenched with CVS and the other bad actors.

      This administration’s hands are tied, but of course it will be blamed by people who fail to listen to warnings or even to know what happened.

      g

    2. Hi again,

      If you want to try, it’s best to file a MedWatch complaint. When the first two inferior generics came out, in 2014, I contacted the FDA and spoke to an assistant to the director. She suggested that I open a MedWatch complaint.

      That’s how we did it. AS I said, I don’t hold out hope. The previous White House administration made this mess, and I can’t imagine the lawsuits against the FDA if they were to reverse it now.

      But….. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
      Gina

    3. Sent. Dang I can’t believe this. I started it a week ago and it has been a game changer.

    4. I am newly diagnosed and it was a tough decision to try meds at all, to commit to taking a medication all the time as maintenance. I expected to have the first thing I took not work that well, but it has been great, exactly what I need, and now…well I’m extremely frustrated. I find dealing with insurance so stressful that it is a barrier to care for me, I’ll avoid care because getting my insurance company to actually cover things is so difficult sometimes. I’m concerned I’ll be in that situation again with this medication that works really well for me.

    5. I understand your concerns, Alice. I seriously do.

      Maybe take it one day at a time.

      Call your pharmacy benefit manager and see what ADHD medications ARE covered (as generic or brand).

      g

  17. Brendan Anderson

    to J&J: Why would you cancel authorized generics when they are increasing YoY? Doesn’t make any sense.

    1. Because it’s more complicated than that. 🙂

      Janssen has made the authorized-generic available for an unprecedented time. Long after the patent expired. I don’t know of another pharma that’s done anything like that.

      But Big Generic and its junk Concerta knockoffs spoiled the market. Now Janssen cannot compete in the generics market.

      g

  18. We recently received notification that our CVS/Caremark policy which has required branded Concerta for the last two years is switching back to *not* covering the name brand as of Jan 1st. So, generics are impossible to find and now they aren’t going to cover the branded product. This sounds like a fantastic combination of situations. Can’t wait.

    1. Im in the same boat Deborah. Cvs caremark covered brand for 2 years and now only covering generics or other drugs. So upset by this. My daughter needs the medication to function.

    2. Same exact boat. No generic available, and Caremark not covering the brand name at all. Who will actually buy brand Concerta now when it’s $500/month and insurance doesn’t cover it?

  19. Katherine Howe

    This is so upsetting. When I read the comment the other day about Patriot no longer distributing the authorized generic I figured some other company would pick it up. I’m very sad that it won’t be available AT ALL. My college daughter has taken this medicine since third grade. The inferior generics she tried didn’t work for her. Without her medication she cannot function.

    Kathy

    1. Hi Katherine,

      This is a long out-of-patent medication. The last couple of years Janssen, Concerta’s manufacturer, had been making it available as an authorized generic.

      No other company can “pick it up” — the authorized generic is the brand. It’s just marketed as the generic. And the brand is proprietary.

      g

  20. I have been able to get the brand through my insurance successfully for the last few years. For 2023, I’m told we need Prior authorization.

    If we don’t get it, then I assume I’m paying out of pocket using GoodRX for Brand. At this time in her studies, we cant afford any medicine changes.

    Am I missing something else I can do?

    Thanks Gina for this.

    1. Any more guidance on what I can do Gina in this case Gina.
      She has to take Brand. So if insurance doesn’t cover or we don’t get Prior approval , we are stuck with out of pocket cost?

  21. Katherine Biscoe

    Hello Gina, a woman at Patriot named Noreen has been extremely helpful in the past. Here is her number:
    +1 (215) 325-7676
    Also, where do I leave a comment for J&J executives?
    Thank you for all your work!
    Kate

    1. Hi Katherine,

      1. Yes, I’m the one who publicized the Patriot # a long time ago. We’re beyond that now. 🙁
      2. Leave your comment right here.

      thanks!
      g

  22. Bruce J. Turner

    This is crushing news. I have been taking the “authorized generic” for many years. My original scripts were for the 54 mg pills, but, as long as I am not actively teaching, I discovered some years ago that the 36 mg dose worked adequately. I am retired and teach only episodically, but when I do I use the higher dose (I have a “stash,” stored in a deep freeze). At some point, the big chain store pharmacies in my area (Kroger, CVS) could no longer obtain the authorized generic, but, eventually, I asked a local independent pharmacy to obtain it and they were able to source it directly from Patriot. During the interim period I tried several of the fake generics, but they were completely ineffective, and one brand made me consistently quite dizzy. I have severe ADD and often have serious difficulty focusing and completing tasks.; aging hasn’t helped (I am 77). I am utterly reliant on the authorized generic/Concerta oros technology. Other stimulants do not work nearly as well (I’ve tried almost all of them at one time or another). If I cannot obtain the authorized generic, my quality of life, including my ability to take care of myself and tend to my needs, will almost certainly be compromised or degraded. My health challenges include RA, complicated by Sjogren’s syndrome. I have been able to slow the inevitable decline that these conditions entail by the use of drugs, daily exercise routines, and strict diet regimens. Managing these requires relatively high levels of mental alertness, focus, and organization – and these are notoriously in short supply with ADD patients like myself. Thus, my ability to manage the progression of the disease that will very likely shorten my life, and has already degraded its quality, directly depends on access to authorized generic concerta. I am at a loss as to what I might do when it is no longer available. I don’t think I will be able to afford the “brand.”

    1. Hi Bruce,

      I hate being the bearer of this disturbing news.

      You might want to think about drafting a letter, getting your information together on which other generics you tried and the adverse effects. Your physician could submit it in hope of your insurance company (or is it Medicare) approving brand Concerta.

      best of luck to you (and us all!)

      g

  23. It sounds like your insurance is equivalent to mine – I had trouble getting the authorized generic for my son for a while, so I got him approved for the name brand, only to find out we had to meet the deductible before it made a difference, and we have rarely spent $6000 in a year that applies to the deductible. He tried 3 of the generics, and every one of them was worse than not taking anything. Most of the day he either had too much or too little medicine in his system, and that just doesn’t work. We really need to get the approval process changed to include more proof that the generic will work like the name brand! That is the only way this kind of issue will end.

    1. Hi Sherry,

      That ship sailed in 2017. We can’t turn back the clock. Elections have consequences and Trump’s FDA Chief brought us here with these generics.

      It wasn’t FDA scientists. They protested — and were over-ruled.

      If you’re in open enrollment now, you might want to think about getting a lower out-of-pocket, if you can’t get the brand.

      g

    2. Changing insurance won’t help – NONE available to me have coverage of brand Concerta, they only cover the generics. According to Walgreens, the only reason I have been able to get the authorized generic is because Texas Medicaid would only pay for it, not name brand and not any other generic. Now that is not an option, and I have no idea what we will do. The last time we were unable to get the authorized generic (for about 6 months), we were unable to find an adequate replacement. Looks like the 2nd half of my son’s senior year will a difficult one.

  24. I am absolutely going to cry. I’m sitting hear looking at the title of this blog post, stunned, and I’m going to cry for my college daughter. She just moved from a pediatrician to using student health doctor to get her prescription written just right and was out of medication for over a week getting things straight. And now this? She barely holds her pieces together and now… I am absolutely devastated.

    We used to have insurance that only paid for the brand, but with the proliferation of crap generics, the insurance no longer pays for the brand. Gina – I appreciate your doing this before open enrollment, but apart from increasing my flex pay withholdings (which would never be enough to pay $6k out of pocket next year), if insurance plan does not cover the brand, then I have found the Concerta coupon is not usable.

    It is corporate greed.

    Thinking about this, I wonder if this decision is related to the power given to Medicare to negotiate with the drug companies for senior’s prescription costs. Now these companies need a different avenue for revenues.

    1. HI Monica,

      I know. So disappointing and affecting so many people’s lives.

      Did you read the post? I doubt it has anything to do with Medicare. That’s not the target group for Concerta. (Not yet!)

      It has to be directly related to the Trump White House FDA chief cursing us with these junk generics. They cost pennies to make. Concerta’s OROS is much more expensive. How can it compete?

      Let’s hope we can figure this out.

      take care
      g

  25. Noooooo! My daughter needs this medication every day. Insurance will not cover the brand name, and they have the best capsule release system. What are we supposed to do? This makes me want to cry.

  26. This is NOT good in tandem with other news I received today from our pharmacist.

    My child takes the unauthorized generic Concerta and it works fine for them. The pharmacy just called me today and said there is a backorder on generic Concerta. They will not be able to fill it for us next month. All dose levels too. My child cannot attend school without it. We will have no choice to go on the brand name Concerta, which is fine. However, I’m worried that with the backorder on generic, the brand name will become scarce too.

    It may be because of the Adderall shortage that doctors are moving patients to generic Concerta, causing generic Concerta to now have a shortage. Lesson is: Refill as soon as you can. I fear that bad situation is about to get worse.

    1. Hi there, Wow, so a methylphenidate shortage, it seems, at least with some companies.

      I agree. Plausible theory/ COVID-related push to diagnosis and treatment resulted in over-prescribing of Adderall. Typical phenomenon, however wrong-headed.

      So, maybe those people are burning out on Adderall and are moving to Concerta or other MPH stimulants.

      good luck!
      g

      The DEA limits amounts of raw ingredients for stimulants annually, and I imagine the amount has not been increased.

  27. Gina,
    Please let us know what more we can do to encourage Janson to keep an authorized generic because it insures the quality of Concerta. I have personally written Jansen and never heard back. My own child tried a non authorized generic when she was 16 and the side effects were frightening. She had what I would consider a psychotic episode. Her behavior was so concerning my husband would not allow her to leave the house or drive for 24 hours. Concerta when formulated properly is a wonderful med and has helped our now young adult daughter be successful academically and socially.

  28. Years ago, early on in our ADHD Treatment Plans, my son and I both were prescribed Concerta; I can still vividly recall the miraculously positive effects of my first therapeutic-level dose of Concerta–and my son also benefitted.

    Unfortunately, we also both had the misfortune of being switched to a useless “Concerta” Generic (one without Concerta’s unique delivery system). Its appearance was easily seen to be different, and in one dose, it was clear that it was not therapeutic–at all.

    (Reminds me of the time I picked up a pair of new glasses with a my new prescription, reflecting my slightly changed vision; they seemed off, right away, but I was encouraged to give them a try. Within hours of constant wearing of the new glasses, I had blurred vision in one eye, headaches, and some dizziness. When I returned to my eyecare center the next week, someone discovered the Optician had erroneously recorded incorrect numbers for the one (blurry), eye. After the lense was replaced with the actual, correct prescription numbers, I could see clearly again–headache-free, with no dizziness!)

    It pains me to think of the many people who currently rely on the efficacy of “Concerta”–who will with–or without–warning be made to endure the stress (and potential danger) of taking a useless “Concerta” generic. It is baffling, and truly unacceptable that this can be happening–especially after the recent bad history of Concerta Generics. It’s enraging, but ultimately heart-breaking.
    I will now proceed to try to Boycott all Johnson & Johnson Products.

  29. Hi, my name is Anna, and I am currently a senior in college studying film and graphic design.

    I have been taking ADHD medicine since I’ve been in elementary school; throughout middle and high school, I remember trying so many different types of ADHD medicine.

    It wasn’t until I came across Concerta (Patriot authorized-generic) that I finally found the right ADHD medicine. As a senior college student studying film and graphic design, I am getting ready for next semester to work on two of the most significant projects I have ever gotten in college.

    You would think the only thing I should be stressing about is making sure my senior projects go as smoothly as they can, but once I heard the news that now I might not have my ADHD medicine has been putting a little more stress on me than it should have.

    I remember one day, I sadly forgot to take my ADHD medicine before heading to work. At the time, I was a graphic designer for my school, and my boss asked me to fix one basic thing on a poster, and it ended up taking me three hours to do because I kept getting distracted by every small thing.

    The next day I had a meeting with my boss, and she almost fired me because of how long it took me to fix the poster; thankfully, I didn’t get fired, but I was close to it.

    This is just one situation of me not taking my ADHD medicine. I know I will have all next semester to work on my senior projects, but I am now worried it might take me twice as long because I won’t have my ADHD medicine. Please let me know if there is anything I can do to make sure the Concerta Patriot brand will be available next year.

    Thank you,
    Anna

  30. This is so wrong on their part. I FINALLY got it all straightened out with my Dr and the idiot Walgreens I have to use (they literally have a 1.5* rating they are so bad). I hope I can get another 90 day and figure it out in the time frame.

    As a side note for people that had issues with other generics (actual side effects). Document that and you may have to have your doctor fill out the paperwork with your insurance for a ‘Prior Authorization’ which would allow you to get name brand under your coverage that only covers generic. I had spoken to my insurance about it as they don’t cover name Concerta, and I had gone through 4 pharmacies trying to order the Patriot, all of which refused. I basically pleaded to them and asked ‘how can a pharmacy REFUSE to order a prescription that is specifically prescribed by my doctor??? At some point someone has to order it…’ it wasn’t even about the payment at that point. It was that every pharmacy refused to order it. I would have gone brand, but brand wasn’t covered by my insurance.

    1. Hi Jackie,

      I hear your frustration.

      Actually, Walgreen’s came through for many years, for Concerta authorized-generic users. When few other pharmacies did. Including CVS.

      But these pharmacies have been, for the most part, losing money filling these prescriptions.

      The problem is the inferior generics are so cheap.

      A pharmacy can refuse to order a medication that they cannot get or that is not covered by your insurance, but state laws vary.

      good luck,
      g

    1. super disappointed as it looked like concerta was going to be a hit for me and now i have to change insurance companies in january with one of my options covering barely any MPH based medications 🙁

  31. Leah Matthias

    I am a 75-year-old woman who has been taking Concerta and then the Patriot brand generic for at least 25 years. My husband and children can attest to the fact that it helps me significantly. I am extremely sensitive to the other generics that make me dizzy, nauseated and feeling out of control. Being on Medicare means that I can’t even get the brand name cheaper. I am very upset.

    1. I’m so sorry to have upset you, Leah. I was pretty upset when I heard the news, too, thinking about the potential impact on so many.

      Who knows…maybe new deals will be cut and you can get the brand. Or, you might find that a non-Concerta stimulant works well for you.

      There are many other methylphenidate choices.

      Thanks for your comment, and good luck!

      g

  32. Just tried to fill my prescription for BRAND Concerta and was told by my Nashville Walgreen’s that “there is a manufacturing issue (not a distributor issue) and we don’t know when we’ll be able to get BRAND Concerta again”.

  33. Absolutely unbelievable. It was extremely time-consuming and difficult to get the Patriot version of Concerta on the regular. When I finally solved that issue, Janssen makes the ridiculous (and apparently self-serving) decision to cease offering it (all without any type of advanced notice). This is going to leave a huge void in patient care. This was the only medication that worked well for my two kids. This is highly disappointing and beyond incredibly frustrating.

  34. I can only hope my employer doesn’t switch back to BlueCross as our insurance provider. If we do, I’ll have to change medications, or go without medication. We currently have United Healthcare, and United only covers brand name medications for ADHD medications.

    1. Aaron, Do you know if that UHC policy (Brand only for ADHD Meds) applies to ALL their many different plans, or perhaps just your particular type of plan? Also, do you mean to say that they WON’T cover generics, even if that’s what the patient wants and Dr. prescribes? It’s one thing to be ABLE to get Brand, but another to be FORCED to do so. I need to pick a new insurance company soon, so any further info you can provide about United Healthcare’s Prescription Policy would be greatly appreciated!

    2. Hi Ann — I’ll pipe in. I have heard some insurance plans covering ONLY the Concerta brand.

      I would check first-hand with any plan you are considering. Plans differ, even within the same provider.

      g

  35. Patricia Thompson

    I guess none of the executives truly care about the people who rely on concerta. Now my poor 9 year old will have to go back to headaches, nausea, and inability to concentrate like he experienced on the other generics. Disgusting and horribly frustrating!

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