Janssen Quietly Ends Concerta Authorized-Generic

Janssen Ends Concerta Authorized-Generic

Concerta manufacturer Janssen officially ended availability of its authorized-generic  mid-January 2023, through its Patriot subsidiary. In this post, I explain what this might mean for Concerta users. I’ll also touch upon the concurrent reported shortages of Adderall. A “perfect storm” of events has made this issue complicated.

First of all, let me validate reactions: The elimination of the Concerta authorized-generic (brand sold as a generic) is a shocking announcement. A massive change. Moreover, it comes amidst an overall stimulant shortage. I see four major causes for the overall stimulant shortage:

  1. A surge in diagnoses during COVID
  2. Alleged problems at generic manufacturer Teva’s Adderall plant
  3. Prescribers overly relying on 2-3 stimulants, being unfamiliar with other choices
  4. “Big Generic” disrupting the ADHD medication landscape
  5. Pharmacy Benefit Managers (PBMs) manipulating access and costs—to great (if partially hidden) profit

The reality is, Concerta users accustomed to paying generic prices were feeling the pinch as early as October, 2022. (I issued the first warning mid-November 2022.). Others are still scrambling to know what’s happening. If that’s you, you’ve come to the right place.

Update April 2023

Readers report being able to get Concerta, sometimes covered by their pharmacy insurance benefit. But some have had to go through Prior Authorization (sometimes called an Exception Process: the term varies).. That is, they had to try two other methylphenidate generics first, to poor effect. Only then could they access brand Concerta.  At a brand price. Check out the tips below.

As ADHD Roller Coaster blog readers know, the authorized-generic is the brand. It’s only sold as a generic. ( Need more background on this, check the link at the end of this post.) When a slew of cheap Concerta generics entered the market in 2017, that scrambled the playing field.

Now, Big Generic is seemingly driving—and in some cases seemingly colluding with—pharmacy-benefit managers and others in the supply chain to eliminate access to many brand medications. That means even getting the brand Concerta is difficult for many (not all) consumers who could get it previously, albeit at a higher (but not exorbitant) price.

If you aren’t familiar with the role of pharmacy-benefit managers (PBMs) in this Hot Mess, read my latest post:  PBMs Restrict Access to ADHD Medications

You  can listen to the podcast version of this post, below.  Please note: When I recorded that, there was reason to believe that Concerta might be eliminated entirely. That does not seem to be the case. For now.

In This Post on Concerta Generics:

I wish I had a magic wand that could summarize the complexity into a simple meme.  Unfortunately, I do not.

Without the details, many readers will remain confused.  Then I’ll try to respond in a comment‚ thus making it even more confusing!

I’ve done my best to organize the complexity by  clear sub-topics. Do read through all if you can. (Or listen to the podcast!)

  1. A little background on Concerta generic vs  suthorized generic
  2. What’s the current news on Concerta?
  3. What does this mean for consumers?
  4. Other ADHD medication shortages
  5. Try not to panic
  6. What’s the big deal with Concerta generics again?
  7. Tips in the meantime
  8. Report adverse events to the FDA
  9. Why Concerta users have been fortunate for years
  10. Big picture – the changing Concerta landscape
  11. Janssen executives – leave a message for them if you like!
  12. My comprehensive post on the Concerta generic issue

1. A Little Background on Concerta Generics:

ADHD Roller Coaster readers have followed my posts on this ongoing story since 2014.  Many took my suggestion to file FDA MedWatch complaints when the first two Concerta generics made their way to an unsuspecting public.

Our actions resulted in the FDA  reconsidering and downgrading the first two Concerta generics as non-bioequivalent. That is, not close enough to Concerta. Victory to the proletariat!

Meanwhile, many consumers could still get brand Concerta at a generic price. That’s because Concerta manufacturer Janssen made the brand available as an authorized-generic. ADHD Roller Coaster readers saved untold sums of money following the advice I carefully laid out.

Then 2017 saw a new White House administration. Its newly appointed FDA chief  pushed through many generics, including Concerta generics. This despite FDA scientists’ concerns about lack of bioequivalence. That is, these generics didn’t work as Concerta works.

If you’re just starting to learn about what constitutes a generic, be sure to check out my most popular comprehensive post. (I’ll link to it at the end rather than distract you now!) Alas, the advice for procuring the Concerta authorized-generic no longer applies. But the post might help you understand a bit more about generic medications. Including such terms as authorized-generic (brand sold as a generic).

Now that the authorized-generic Concerta has been eliminated, the tea leaves suggest brand Concerta might remain harder to get.

  • Compared to just one year ago, it seems far  fewer insurance policies are covering brand — any kind of brand medications — for ADHD.
  • Concerta manufacturer Janssen’s Vacaville Alza manufacturing plant has been scaling back for years. (Alza makes OROS™, the patented delivery system unique to Concerta.)
  • Yet, Janssen also manufactures the Alza devices in Gurabo, Puerto Rico. (My call to that plant gave me another person to call, in Switzerland. Still waiting on a response.)

2. What’s The Current News on Concerta?

A few years ago, Concerta manufacturer Janssen (a division of Johnson & Johnson) created subsidiary Patriot to distribute its authorized-generic products.

On Dec. 2. a Janssen-Patriot representative told me that warehouses received their final supplies of Concerta authorized-generic weeks ago.

When those supplies are exhausted, that’s it. (The deal officially ended 1/13/23.) No other information was available.

On 12/9/22, the FDA finally posted on its website the notice Patriot authorized-generic for Concerta discontinuation notice. That’s weeks after I gave readers a heads-up in the first version of  this post.

Janssen would not indicate if Concerta brand prices are being negotiated. Rumors have circulated  that J&J/Janssen might sell Concerta to another company.  How would that company would fare any better,  competing with a slew of dirt-cheaply made generics? Unclear. Plus, that company would have to buy or license the Alza OROS™ patent. I’ll let subscribers know as I learn more.

A reader shared one data point casting doubt on Concerta’s continued manufacture: Janssen parent company J&J started scaling back production at its Alza plant in 2019.

Excerpt from FiercePharma’s Janssen Laying Off 4 Dozen Employees as California Plant Heads Towards Closure:

J&J says the closure is part of an effort to rework its manufacturing network as its drug portfolio changes.

“As part of this transformation, we will scale down production at our Vacaville, California facility with the intent to fully exit the site by the end of 2022,” J&J spokesman Matthew Johnson said. [Again, the Puerto Rico plant still products Concerta, as far as I know at this point.]

Janssen, like other drugmakers, is putting more effort into areas such as immunology that involve biologic drugs.

Indeed, J&J re-targeting of health conditions at that time resulted in Crohn’s disease drug Stelar being its current biggest seller.  Sales of Johnson & Johnson’s Top Pharmaceutical Products 2020-2022. 

Yet, as far as I know, J&J continues to manufacture Concerta at its Puerto Rico Plant.

3. What Does This Mean for Concerta Consumers?

What does this mean for consumers who have relied on this ADHD stimulant medication for years?

That depends on many factors, including personal resources:

  • Insurance pharmacy benefit terms 
  • Symptom severity 
  • Prescriber’s expertise and willingness to help you manage a good strategy

Below, you’ll find a few tips and a request—please report any adverse events with the Concerta and any other generics to the FDA. Link below. 

Consumers have been vulnerable pawns in this game. It’s way past time  we make our voices heard. We did it in 2014, so let’s try again.

Please know: Rail against insurance companies all you like. That doesn’t mean insurers are the primary culprit here. This is a complex situation. The ADHD communities in countries with single-payer health systems are faring much worse. MUCH worse.   When we focus on the wrong problem, we get the wrong solutions.

4. Other ADHD Medication Shortages

This cataclysmic change has been intensified by an overall shortage of stimulant medications, including the Concerta generics and Adderall.

Yes, we’ve seen an ongoing surge in diagnoses thanks to COVID pushing long-lingering issues to the fore. Some attribute the shortage in part to the U.S. Drug Enforcement Agency (DEA) not upwardly revising its annual limits on stimulant raw materials.  The DEA website claims it has increased limits. But I’ve seen no firm numbers on that.

NBC News reported 8/26/22: Adderall hard to find at some pharmacies following a labor shortage at the largest U.S. supplier Excerpt:

Teva Pharmaceuticals attributed the delay to a labor shortage on its packaging line that it said has been resolved. The company added that it has an “active supply” of branded Adderall and its generic version, and that while some pharmacies may experience a back order, it should be temporary.

Bloomberg reported on  1/5/23: ADHD Drug Shortages Spread to Generic Ritalin.  Excerpt:

Shortages of ADHD medications that started this summer with Adderall have widened to now include another major category of stimulants.

For the past two months, patients have had a hard time finding methylphenidate drugs, a class that includes Novartis AG’s Ritalin and Johnson & Johnson’s Concerta. [Johnson & Johnson is Janssen’s parent company.] A drug manufacturer and a major pharmacy told Bloomberg News there are issues with the supply of the drugs, though it’s unclear what’s causing the shortage.

don't panic concerta generic shakeup

5. Let’s Try Not to Panic!

Instead, use this time to gather information and get your ducks in a row. There are several fluctuating factors, and it might take a while for the dust to settle.

For example:

  1. It’s always tricky at year end, as stimulant raw materials run low, thanks to the DEA’s seemingly overly zealous restrictions.
  2. Some supply issues might resolve by January—at least by March.
  3. We just don’t know what Janssen might do in 2023 in terms of making the brand Concerta more accessible and affordable. What deals might it be cutting with pharmacies and insurers?

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 inform customers about anything. That went out with the flood.)

As previously mentioned, I’ve kept readers informed on Concerta and its generics  (and generics in general) for almost a decade. You can read a historical overview here: Generic ADHD Medications: Events In the News 2009 to 2022

6. Again — What’s the Big Deal with Concerta Generics?

Someone wrote on my Facebook page: “I like the Trigen, Gina. Concerta is not the GOD of stimulants.”

Unfortunately, that reader confidently assumes she has a handle on what’s happening—and she clearly doesn’t.

In fact, Trigen’s generic for Concerta has long caused problems for some Concerta users who’ve tried it.  Read the comments to the linked overview story at the end of this post.

Moreover, I never claimed Concerta is a GOD or in any other way superior to other stimulant choices.  I claimed (correctly) only this: Concerta is a very popular choice that millions have relied upon for years—and they are losing it without a likely similar replacement.

Simply put, the Concerta generics don’t work as Concerta does. In other words, if you get best results from Concerta, chances are good these generics won’t work as well for you.  On the other hand, if Concerta does not work well for you, one of these generics might work better.

The issue isn’t that these are “bad drugs.” The issue is this: They don’t work as Concerta works. They are not bioequivalent, in other words, no matter what the Trump-appointed  FDA chief said in 2017.

Scott Gottlieb, MD, in 2017 overrode FDA scientists’ objections in approving this slew of products from “Big Generic.”  Undoubtedly, pharmacies and insurers see enormous profit margins with these pennies-to-produce generics made in poorly regulated factories overseas.

See my post Bottle of Lies Exposes Generic Drugs

Tips for dealing with Concerta generic problems

7. Meanwhile, Consider These Tips

The main thing is: Don’t wait until the last minute to fill your prescription! Something might be better than nothing.  (In the case of some generics, however, something might be worse than nothing. It all depends on personal response.)

I’ve assembled a few suggestions here.

—Get Familiar with Pharmacy Benefit Details and Workarounds

  • Check to see if you can get brand Concerta—at what price and what is your out-of-pocket maximum.
  • See if there is a cost difference between 30-day local and 90-day home-delivery pharmacy: Home Delivery of Prescribed Stimulant Medications
  • Know that the big national warehouse pharmacies (e.g. Express Scripts) typically have greater supplies than local pharmacies.
  • Call your pharmacy benefits manager (or check the website) to see which ADHD medications you can get, as generic or brand. This is typically called the formulary.
  • 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. (While you’re at it, complete an FDA Medwatch form, below.)

—Check Out Savings Programs

  • See if the Concerta savings coupon works with your insurance (not available in CA and MA). Unfortunately, this requires your insurance covering brand.
  • Check to see if you qualify for Janssen’s Patient Assistance Program. That program ended January 1, 2023.
  • GoodRx used to be helpful sometimes with getting brand Concerta. Now I see it doesn’t even list it or the authorized-generic as an option.

—Start Trying Other Brand Methylphenidate (MPH) Stimulants, If Possible

Trying a new medication via the brand eliminates any variables that would come with generics. That way, if that medication doesn’t work well for you, at least you’ll know it wasn’t due to different delivery systems, binders, colorants, and fillers.

Some brand medications have no generics yet. Therefore, it might be easier to get them over other brands for which we do have generics.  (In the amphetamine class of stimulants, Vyvanse is one such example.)

More points:

—Check Out Non-Concerta Generic MPH Stimulants

  • There are many generic methylphenidate options. Compared to Concerta’s OROS™, their simpler delivery system might mean they work similar to the brand.
  • Check out the generics for Daytrana (patch), Metadate CD, Ritalin LA, Ritalin SR, and Methylin ER.

—Ever Tried an Amphetamine (AMP) Stimulant?

  • If you’ve never tried a stimulant in the amphetamine class, you might want to do so now.
  •  Prescribers have been trained by sales reps to automatically choose Adderall first. But there is no evidence for it. Moreover, it has the highest side-effect profile among the stimulants.
  •  Vyvanse might be a better choice for many, at least to start. And again, there is no generic yet.  It all depends on your unique biochemistry.
  • Some people take Dexedrine, but the old formulations’ abrupt stop-and-start is problematic for many.
  • There are other AMP formulations, too.

—Maximize Health and Supportive Strategies

What the silver lining of this cloud? Perhaps it’s a good opportunity to start optimizing all the strategies that support health and executive functioning,

Let’s face it. Some folks do over-rely on a stimulant to propel them through their day. This is especially true with Adderall, in my observation.

With better sleep, nutrition, exercise and new skills and habits to support Executive Functions, some folks find they need less medication.  The higher the dose, the greater the odds for side effects.

Therefore, start doing what you can to improve brain function in other ways, including:

  • Getting consistently better sleep sleep (same time to bed and awaken, every day)
  • Improved diet and exercise
  • Sunlight in the morning, lower lights in the evening
  • Doubling down on using tools for goal-setting and time-management

Again,  any of these steps  might increase the odds of an alternative stimulant working better for you. More importantly, they are part of the recommended “multi-modal” treatment for ADHD. medication along is seldom enough.

[advertising; not endorsement]




[advertising; not endorsement]

FDA medwatch complaint concerta generics

8. Adverse Reaction? File an FDA MedWatch Complaint

This is how we got the first two inferior Concerta generics downgraded from its bioequivalent status with the FDA.  Meaning: consumers were no longer forced to accept them as a generic for Concerta.

It only takes a minute. And the FDA does pay attention (now): FDA MedWatch Voluntary Report

9. Why Concerta Users Have Been Lucky For Years

Lest we forget: It’s been a rare good fortune to have had the Concerta authorized-generic (brand sold as a generic) for so long. It seems unprecedented.

Originally, J&J made marketing deals with generic manufacturers hot to launch their Concerta generic.  Delay your own generic, the deal went, and we’ll let you sell the brand at a generic price.  That deal was extended a few times.

Then the circus came to down, bringing with its clown car of Concerta generics.

10. Big Picture: 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 in 2017. With a new FDA chief appointed by the new White House administration, “Big Generic” unleashed a slew of Concerta generics. None of them use Concerta’s patented delivery system, OROS™. 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 succeeded in getting brand Concerta at a generic price. But insurance companies and pharmacies paid a higher price, compared to the inferior generics.

11. Tell Janssen Executives What You Think

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.

Multiple efforts to get more details today from Janssen  or J&J have failed.  Apparently, company executives find it a trivial matter—cutting off longtime customers from a treatment they’ve come to rely upon.   With my most recent effort, Dec. 2, I was told only what I wrote at the beginning of this post. That is, the last supply went out a few weeks ago. When those are gone, the authorized-generic is no more.

You are welcome to write to the two executives below at this address:

1000 Route 202 South
Raritan, NJ 08869
USA

 

Jennifer Taubert, Executive Vice President
Worldwide Chairman, Pharmaceuticals, Janssen Pharmaceuticals

Vanessa Broadhurst. Company Group Chairman
Global Commercial Strategy OrganizationJanssen Pharmaceuticals

Johnson & Johnson Executives Authorized-generic Concerta

12. My Comprehensive Post on Concerta Generics

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

As I mentioned above, it is outdated in terms of how you might procure the authorized-generic. But it does explain the differences among generics.

The first version of this post appeared 12/1/22.

About The Author

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

  1. Hi Gina,

    Just wanted to mention that we’ve had really good luck with Azstarys for my 15-year-old son. He takes the middle dose (39.2mg ). Previously he was on Concerta (the authorized generic) for about 10 years, usually at 54mg.

    Right now, it’s easy to get Azstarys with the online coupon for $50 a month. My son says it feels very similar to Concerta, in terms of how it kicks in and how long it lasts. He says it’s pretty smooth on both ends (Concerta used to give him stomach ache/nausea for a few min while taking effect, but Azstarys does not), and there’s no cranky coming down from the med, either.

    Just FYI, in case it helps someone else.

    That said, my daughter (same age — they’re twins) didn’t love how Azstarys felt. I think that may have been a dosage thing — she used to take a low dose of Concerta (27mg) just for school days, so the 39.2 Azstarys that she tried for a couple days was probably just too high. We switched to Metadate CD for her, and it was okay, but we’re trying to determine if she needs ADHD meds at all. (We more likely need to address her anxiety, but that’s a whole other can of worms!)

    1. Thanks for the feedback, Tina. That makes several positive reviews of Azstarys, so I’m glad I mentioned it in the post. (I have no business relationships!)

      Maybe try your girl on a more equivalent dose perhaps? Also, remember that ADHD-related cognitive anxiety can look like an anxiety disorder to the less-than-astute clinician.

      best,
      g

    1. Ha! Thank you, Lyra! My sainthood would surprise my 7th grade teacher, Sister Mary Olive. But she had it out for me. 🙂

      Cheers
      g

  2. thank you for posting this. Keep the info coming. The situation is crazy.
    I’ve filled complaints to FDA and hit up the Janssen execs

  3. Thank you so much for this info. I’m just at a complete loss for what to do. My 11-year-old son has been on methylphenidate for years and he’s doing great. We’ve tried generics, but the authorized generic of Concerta is the only medication works. I’ve been chasing down the Patriot methylyphenidate at various pharmacies for the past few months because it’s been so hard to find. I’d hoped it was a temporary shortage. Now I’m trying to find a way not to pay $400/mo for name-brand Concerta and am devastated to read even that will be discontinued. I’m not sure what to do. Should we try a different Concerta generic and see if we have better luck this time? Or should we try another ADHD medication altogether…? This just gutting and I’m worried my son, who is thriving academically, is going to struggle because some pharma execs decided kids like him don’t matter as much as money does.

    1. Hi Kimberly,

      I understand your distress. I wish you’d found my blog sooner — to save all the running around.

      It’s important to know, though, that there are other choices, beyond the Concerta generics. Maybe this summer you can try a few.

      Please read the post’s tips on filing an exception-process. If you’ve already tried those generics, to poor effect, you should have the necessary information. Your MD will have to file the request, but it will expedite things if you present the information in handy written form. Names. Dates. Results.

      To clarify two points:

      I did not say that Concerta itself will be eliminated. So far, there is a supply. We just don’t know going forward. It’s an expensive drug, compared to these junk generics.

      —It’s not the “pharma execs” or insurance companies who created this misery. It’s Big Generic in collusion with the Trump administration’s FDA Chief — and pharmacy benefit managers.

      good luck,
      Gina

    2. Hi Kimberly,

      My 14-year old son had been using Concerta (and the authorized generic) for many years! When it came time to refill in January, when all of this went down, it was such a struggle to find an effective alternative. I was stressed to say the least – he is a truly bright student but benefitted from Concerta to stay focused and on track. I tried having him off Concerta for a time last year and his gifted ELA teacher begged to have him back on after two days.

      My insurance covers Quillivant/Quillichew and my son has been doing really well on the liquid Quillivant.

      I would suggest discussing options with your son’s pediatrician, with the hope that he or she is knowledgeable about the gamut of ADHD medications! There are options out there that are promising. I hope you find an alternative that works for your son!

      Regards,
      Elaine

    3. Hi Elaine,

      That’s great…that you found a workable alternative.

      I wrote about Quillivant and Quillichew years ago — and suggested in this post to look into alternatives such as that.

      https://adhdrollercoaster.org/adhd-news-and-research/a-new-ritalin-extended-release-liquid/

      Unfortunately, many prescribers remain unaware of what is available. And some are not covered.

      I recommend avoiding time-wasting back and forth by first getting the details on one’s pharmacy benefit formulary (what is allowed). Mull over the choices and then present the top to to the MD.

      g

    4. Gina,

      You are absolutely right about researching the benefit formulary before presenting to the physician! I had looked up all the other alternatives you had mentioned and only Quillivant and Quillichew were covered by my insurance. I even looked up the Tera generic (which was the only generic that worked for my son) and it wasn’t available.

      Thank you,
      Elaine

    5. Good work, Elaine!

      Doctors are very beleaguered these days. The more we can simplify our requests, the sooner they will be taken care of. imho!
      g

    6. Hi Kimberly – I am in the exact same boat. I have to beg and plead for Caremark to allow an over ride for brand name Concerta. Today, they told me that there is no longer a shortage of the generics and that they will not pay for the brand name any longer. Unfortunately we are not able to take the cheaper generics because of adverse effects. Just wondering what the best alternative might be at this point? Have tried others and nothing works as well as the brand name Concerta – but $400 per month is just not doable in my budget! Please let me know – Gina also what the best alternative to brand name Concerta might be. Adderall for us was awful. TY! So happy to have found this blog.

    7. Hi Margot,

      As my mother used to say, you can’t squeeze blood out of a turnip. And that’s pretty much the situation with Caremark.

      When I saw this mess unfolding, at least five years ago, I came up with a new slogan for Caremark: “If you think we care, you’re a mark.” :-). A mark, meaning someone easily conned.

      The best alternative to brand-name Concerta is the MPH-class stimulant that works for you. No cookie cutters. Some have done well on the Daytrana patch. Some on Quillivant/Quillichew. It really depends on individual physiology.

      I created Course 2 in my Solving Your Adult ADHD Puzzle program to help folks take charge of their medication optimization. We really cannot depend on the average prescriber, including many that claim ADHD expertise.

      You can learn about the other options in the course, and there are worksheets to help methodically guide the selection and titration.

      But the course covers more than medication. It covers all the ADHD-related Physical Strategies — around medications, sleep, nutrition, and exercise. In the process, it covers physical illnesses and conditions that are often associated with ADHD and might be better managed by optimizing ADHD treatment. For example, diabetes.

      Honestly, if more consumers took this course, we could start revolutionizing the standard of care for ADHD. As it is right now, we accept sub-standard ….and even reckless. It’s way past time for that to change. What it will take is consumers learning just a bit — in a very easy and supported way — and learning to be pro-active.

      I cannot imagine why anyone would leave their or their child’s care to chance. And that’s truly what’s happening.

      good luck,
      g

  4. Hello – thanks for this great post and everyone’s comments. Is there any updated information on the availability status of either brand name Concerta or the Patriot generic?

    1. Hi Margot,

      You’re welcome!

      There will be no more authorized-generic. That is what you term the “Patriot generic.” Patriot is a subsidiary of Janssen, Concerta’s. manufacturer. It’s not generic in the usual sense of the word. It is the brand, only marketed/sold as a generic.

      Yes, people are finding brand Concerta. But whether insurance covers it or not…that’s the big variable.

      Good luck,
      g

    2. Hi Margot – In response to your question on my comment above, I did find a way to get name-brand Concerta at closer to $200/mo. (which is still a ton of money, but better than $400/mo.). Here’s what I did:
      – Tried to get a prior authorization through my insurance company. It was denied pending doctor input. Then my son’s pediatrician submitted a letter; I thought it had still been denied, but maybe it wasn’t? When I went to fill the prescription at the pharmacy, they said the name brand was covered.
      – When I went to the pharmacy, I presented the Concerta Savings Program card (free to download online), which only works in the med is covered by your insurance. With that, the price went down to around $200.
      – Note: GoodRx was still showing Concerta at over $350 for all the big pharmacies. I went to the pharmacy associated with my pediatrician’s office healthcare system.

      Hope this helps. I’m sorry my process isn’t totally clear; I was trying everything I could think of all at once and I’m not sure what finally worked in the end.

    3. Thanks for jumping in to help Margot, Kimberly.

      Margot, you might want to read this post, as I covered the points in some detail.

      But Kimberly, were you able to use the Concerta savings card recently? Last I heard from the company, that program had stopped.

      For my ZIP code, GoodRx shows on average $430 for brand Concerta. But some of those have other requirements.

      Costco Pharmacy is the only one that does not, as far as I know.

      g

    4. Gina – Yes, I was able to use the Concerta Savings Program card this month. The pharmacist quoted a higher price ($300something) with just my insurance and then added the Concerta card and the total was $219.

    5. Update: I already had it in the post. lol. It was the patient assistance program that ended. 🙂

      Thanks! I’ll update the post. It’s an ever-changing picture!

      g

  5. I am 58 male and have been diagnosed with ADHD and on medication since Elementary School have been on Methylphenidate 36mg ER OSM Tablet with the inscription of 214 imprinted on the barrel shaped tablet. MFG CAMBER . I take one 36mg Tablet two times a day. One at 6am and the other at 12 Noon. The time ritual has help tremendously for over 15 years with a smooth start and finish to my day. My ADHD has been managed and medically stable during this time. I have been psychologically and psychiatrically evaluated several times in my adult life and ADHD is my only psychiatric diagnosis. Justify my continuation of Stimulant Medication all these years for Medical and Insurance purposes.

    Starting in November 2022 with the shortage I have been unable to get that exact medication. Other ADHD medications from the Methylphenidate name attached (at least 4) have produced horrible effect. They flood my blood stream and metabolized in my system rapidly with HUGE mood swings and feeling out of control.

    My Pharmacist (Walgreens) said that MFG CAMBER has no idea when they will get re stocked. Pharmacist also said that the OSM is the mechanism within the prescription that controls the chemical release and that the other prescriptions I have been prescribed don’t have that mechanism within the prescription making the release raw and dramatic in my system.

    I’m not sure if you are following me but is there any ADHD medication that can be tried that mirrors the stability factor I experienced with the prescription I took for years that worked for me? I have tried for months to get help with this.

    1. Hi Darryl,

      Yes, I follow you.

      I suggest that you first look beyond your local Walgreen’s.

      If you have a home-delivery pharmacy benefit, that might be your best bet. These big national warehouses tend to have a more varied and plentiful supply than local stores.

      Here is a blog post on the topic: https://adhdrollercoaster.org/tools-and-strategies/home-delivery-stimulant-medications/

      Call your pharmacy benefit manager and ask if you have access to such and then ask if they carry the Camber Concerta generic.

      If so, ask your prescriber to specify the Camber Concerta generic on your prescription. I believe the NDC (National Drug Code) number for the 36 mg is: 31722-954-01

      You can check the NDC directory (enter “Camber” and look for methylphenidate in the Concerta dosages….e.g. 27 mg, 36 mg. 54 mg): https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfmhttps://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm

      But it should be enough to write on the Rx: Camber generic only.

      I believe that will be your best strategy now. Good luck!
      Gina

  6. Just popping on here to say that I, too, have had trouble with Trigen’s 36mg ER. Camber was the best of the generics in my experience. Got the job done, with no side effects. I am a 54 yo caucasian female, generally healthy lifestyle, petite, about 10 lbs overweight. No other health issues. The switch to Trigen was significantly different, and comes with side effects like depression, a wicked rebound period, and a few others.

    I am waiting eagerly for any announcement by Camber that their quotas will be refilled soon.

    Thank you for listing some alternatives to Concerta that we can research. Your efforts are so greatly appreciated!

    1. Hi HGH,

      Ah, I did not know that Camber is short. I hope you can get your hands on it soon!

      Thanks for sharing your experience of Trigen.

      And thanks for acknowledging my work. 🙂

      g

  7. Kathryn Boyles

    After being on it since it first started . Switching from Ritalin, I’m now on Adderall . While it dosnt last as long it’s a relief to not have to fight the pharmacy to order a certain brand name . Or to worry about other things or this nature. Thank you for keeping us updated. My doctor asked if the pharmacy got any in and I said no. They are not going to from that company. How do I explain to my doctor that the pharmacy knows very little about this stuff.

    1. Hi Kathryn,

      Good for you. Maybe the situation will change soon, and the brand Concerta will be more accessible.

      In the meantime, I’m glad you found something that works.
      g

  8. Hi,
    Firstly, thank you so much for writing about this issue and being so thorough but also right to the point.

    I wanted some clarity on the difference between generic and name brand Concerta. I have been on the generic brand, labeled methylphenidate er (which I assume is the Patriot one), for almost 20 years, but with the shortage am trying to get my insurance to cover the name brand. Should I be worried about my body reacting differently to the name brand versus generic? I have a very high dosage, 126 mg, and I just want to prepare myself physically and mentally.

    I hope and pray for everyone being effected by this awful circumstantial storm.

    1. Hi Marshall,

      You are most welcome!

      First, it’s important to get clear on the facts of what you are taking now.

      What does it say on the pill and what does the pill look like?

      Only the pills that say “Alza” are the brand Concerta. For years, it was made available as an authorized generic. That’s a brand that is sold as a generic due to marketing agreements, typically with would-be competitors. But it IS the brand.

      Most recently, the Concerta authorized generic was sold by Patriot.

      G

    2. In my experience they are different. I vastly prefer the generic, I dislike the lack of rhythm that the 10h pump imposes on my brain. Sometimes I want to be able to reduce the XR dosage some, and you can’t cut Concerta (well… you can, but don’t – it releases all at once and is awful no good very bad.) So you should prepare for some differences, if you’re sensitive to dosage.

    3. There’s not just one Concerta generic, though, and the issue isn’t what any individual prefers.

      The issue is that the generics do not perform in the same way. That’s a problem.

      G

  9. Oh man! After following your blog through the ups and downs of seeking concerta or its bioequivalent for near a decade (though not checking in for past year), this latest chapter finally caught up to me today and straight to your blog I came. Was blindsided when my Kroger pharmacist (who has always been patient with my special orders and requiring them to show me the pills before I accept the prescription) called to tell me that the generic has been discontinued altogether. Luckily, they said that my insurer will cover the brand name Concerta (though at what price we’ll see tomorrow when I go to pick up) which was not the case at the beginning of 2021. Thank you for all your continued work on this subject. I will continue to check in regularly to see what happens to the Alza plant.

    1. Hi Betty,

      I hope your insurance covers Concerta brand for you. Some policies do.

      As for the Alza plant, I did correct that in the post more than a week ago, so maybe you read that in a comment. I will look for and correct that as well.

      Janssen also has a Concerta plant in Puerto Rico. That does not seem slated for closure.

      Good luck,
      G

  10. Hi Gina. Thank you so much for the information in all of your posts. I was inquiring to see if you have any information on the drug Aptensio XR? When looking at changing to a different medication, this was one our pediatrician suggested. Our insurance only covers generic and this medication is available in a generic form. Our pharmacist has also said that they haven’t had any shortages of this medication (they have had difficulty getting brand Concerta and are now only offering Trigen generic). Any information is appreciated.

    1. Hi Sarah,

      Aptensio is one of the long-acting methylphenidate stimulants, like Concerta. It’s going to work differently than Concerta, because the delivery mechanism is different.

      (The same is true for Adhansia.)

      Whether that works better for your son than Concerta—or worse—the hard truth is this: You don’t know until you try it.

      Good luck!
      G

  11. Gina I love your work. You give so much hope and knowledge. I’ve recently been affected by the concerta issues. I moved over to Azstarys recently and it has been working well for me. Thanks for all you do.

    1. Hi Greg,

      Wonderful!! I’m glad to know that. Good for you, for getting a brand. Always fewer variables.

      And thanks for letting me know my work has helped you.

      cheers
      g

    2. Azstarys so far seems to be working well for my son also, though I think he may be better on the next higher dose. It wasn’t covered by my insurance, but with a coupon it was an acceptable $50 price ($25 if covered by insurance).

      I recently was looking into why brand Concerta appears to be planned for discontinuation, and noticed that the OROS patent is expiring in Jan. 2024. I’m wondering if that might be why Janssen is looking to move on. After that happens, maybe some generics that actually work like Concerta will be released. Or alternatively, completely new brands. Any thoughts?

    3. Hi Sherry,

      That’s great to hear, that Azstarys seems to be working for your son.

      I am not a pharma patent attorney but I know that Janssen owns Alza. I suspect that OROS is more considered a medical device, not a medication.

      Already, the generic Concerta competitors have attempted using osmotic-release delivery systems. None so far, though, worked as OROS does.

      Cheers
      G

  12. It finally caught up with me too. I have been taking the same dosage of Concerta for over 15 years and this is the first time ever where I was slapped with a $500 bill for a month of my medication. In the past I have not had any luck with other medications (or “versions” of Concerta) and am frankly scared to try them now but I am at a loss. I don’t qualify for the savings card (due to my CA insurance).
    On the FDA website it also says that Methylphenidate Hydrochloride Extended Release Tablets for Patirot will be completely discontinued (in all doses) in 2025 so I think that includes both name brand and generic too. Cue even more panic. I hope that something will change in the future but my hopes are not very high.

    1. Hi Katherine,

      Let me clarify: As this article states, the authorized generic has been eliminated, not Concerta itself. That happened in June, 2023. So, I’m not sure what you are referring to with information from the FDA website.

      Concerta manufacturer Janssen sold the authorized generic through its subsidiary, Patriot.

      good luck
      g

  13. I just went through a thankfully relatively short-term panic when I couldn’t get my generic Concerta script filled. My insurance prefers to have prescriptions filled through their mail order pharmacy run by CVS. It’s actually a really great deal when it works ($15 for 90-day supply). I was told it wasn’t available when doctor placed order. Called my local pharmacy they said they didn’t have it. Prescriber suggested Ritalin-LA but when I was originally diagnosed back in 1995 my then prescriber said it wasn’t effective. The funny thing is in 2006 I went off of Ritalin and Concerta because of other health issues. I thought it was going to be a nightmare because in addition to working, I was also just starting grad school. Surprisingly, I had relatively no issues and sailed very successfully to a Masters. I only went back on meds in 2013 because my job at the time was in a very stressful environment. I left it in 2015 for a better job, where I am today. I’ve been on meds ever since. Makes me wonder whether I could switch off of meds again and not have to deal with meds at all!

    1. Hi Amelia,

      that seems a good question to explore.

      The thing is, though, sometimes school is easier than work, in the sense that the structure is provided.

      g

  14. I’ve had issues since December filling Concerta 36 for my twins. So their doc switched them to Methylphenidate ER 20mg, So far that’s ok. This month, I can’t get the ER and we switched to Metadate CD. Now I can’t get that either. So I filled one kid with Metadate CD and the other I need to get a new Rx sent to a different pharmacy to get the ER version since the other pharmacy doesn’t have CD. I am worried the doc is going to start charging me a co-pay for the amount of time he has to re-write the Rx.

    1. Yikes. Prescribers are definitely affected by this mess, too.

      I encourage folks to try 90-day home delivery. More access to greater supply.

      Good luck
      G

  15. My wife’s benefit plan (via Express Scripts) just denied our prior authorization request for brand concerta ER. While none of the alternatives will have the same time-concentration (PK) profile as brand concerta, some may have a PK profile that is more similar. Replacing the no longer available authorized Patriot generic with the methylphenidate ER alternative with the closest PK profile would be preferable. However, as you point out in your posts, the PK profiles of the concerta generics are not obvious, as the generics use the same prescribing information, with the same PK profile, as brand concerta. Do you have the actual PK profiles of any of the generics and/or know how to get them. (I have a some pharmaceutical background and would be happy to discuss outside of the blog technical details(eg, ANDA applications) that might be inappropriate for the posts.)

    1. Hi Robert,

      I wrote about that in an earlier post on Concerta generics (started in 2014). Don’t remember which one and I am on the road now with slooooowwwww Internet.

      Simply put, the generic companies exploited FDA loopholes regarding bioequivalence in novel delivery system medications. aka, Concerta. FDA scientists had long been concerned about this and had been pushing for new guidelines.

      It’s been a while but I don’t think the generics companies had to show a full PK, just an approximation. If that. “It’s genius!” a pharma patent attorney told me. Then my blood ran cold. :-[)

      Someone who worked for one of the original Concerta generic mfr…I won’t say which one…was very adamant in emails to me that I didn’t understand ANDA, that I was wrong about those Rx, etc etc. Oh, but I did, enough to know that these products didn’t act as Concerta acted. And the MedWatch complaints convinced the FDA, too.

      https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-regarding-methylphenidate-hydrochloride-extended-release-tablets-generic
      \
      cheers
      g

    2. In response to Gina’s reply to my 20 feb 23 comment.
      Have you been able to actually see the ANDA PK data for the generics? I have experience with clinical trials and NDA applications and would be able to provide some independent comparison of concerta and generics. While I understand that the generics are not the same as concerta, it could be that they are not all the same amount of different. Knowing the nuances of the differences in PK profile between the various generics might benefit my wife, and others in this predicament, to more rationally switch from authorized Patriot genneric. But as you point out, the prescribing information for the concerta generics are the same as for concerta, thus not their actual PK profile Do you have, or do you know how I might get, the actual PK profiles from the various concerta generics / methylphenicate ER alternatives?

      Your work is really impressive and helpful. In return for your links, here are some that might be helpful to you and others:
      Methylphenidate long-acting (modified-release) preparations: caution if switching between products due to differences in formulations – GOV.UK (www.gov.uk)
      Metrics for the Evaluation of Bioequivalence of Modified-Release Formulations
      Laszlo Endrenyi and Laszlo Tothfalusi
      https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3475860/

    3. Again, these generic companies exploited loopholes. All they had to show was bioavailability of the ingredient at the same amount. But they didn’t have to show therapeutic equivalence….that is, the rate at which the MPH is released.

      This paper might be useful.

      Excerpt

      [this part seems key.]. Under the Fundamental Bioequivalence Assumption, one of the controversial issues is that bioequivalence may not necessarily imply therapeutic equivalence and therapeutic equivalence does not guarantee bioequivalence either.

      The verification of the Fundamental Bioequivalence Assumption, however, is often difficult, if not impossible, without the conduct of clinical trials. In practice, there are four possible scenarios when assessing bioequivalence for generics approval:

      Drug absorption profiles are similar and they are therapeutic equivalent;
      Drug absorption profiles are not similar but they are therapeutic equivalent;
      Drug absorption profiles are similar but they are not therapeutic equivalent;
      Drug absorption profiles are not similar and they are not therapeutic equivalent.

      https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4157693/

      G

  16. Kegan Morrison

    I took brand, then authorized generic Concerta since it first was produced. Due to insurance idiocy I had to switch to a combo of lower dose of Concerta (authorized generic) in morning and several generic Ritalin tablets later in the day. A pain and sort of a defeat of the purpose of extended release-especially for ADHD! But it works mostly. Now insurance has forced me to Trigen and generic Ritalin combo. Trigen is okay, for me. So that setup is acceptable. Trigen is not remotely like Concerta, however. Aliza’s OROS delivery system is exceptional and unique. I’m a materials science engineer and “sectioned” a brand Concerta tablet (when it first came on the market) to actually see how it all worked. The entire system, the quick release drug coating, the semi-permeable membrane tablet enclosure that does not dissolve at all, the absorption/expanding section, the drug section (with slightly variable dissolution sections, and even the precisely drilled drug exit hole is extremely clever and a well integrated combination of systems to deliver a fairly uniform amount of drug over a consistent time.

    What I seldom see in almost all comments, and I surely haven’t read “all” or kept up on this long exasperating saga, is what I’m probably going to now do.

    I’m just going to go back to taking Ritalin, 20 mg throughout the day. I used to forget doses. And I’ll probably still forget. But it may be less stress and hassle. I hope…

    Screw pharma. Screw the insurers. Screw the American medical system. Screw the fda. And worse to politicians.

    1. Hi Kegan,

      I hear you. In this case, it’s not pharma, the insurers, or the American medical system or the FDA. Other countries have it much worse than we do. Single-payer in particular.

      (The UK’s NHS issued a press release that it was moving to the generic Concerta as if it was some big coup it pulled off — to save money and serve more people. Hilarious.)

      It was one corrupt administration that put the screws to all of us, in some ways “Big Pharm” included. It was a gift to Big Generic all the way.

      As far as what people are doing, I made suggestions in the post. Hard to do much more.

      best,
      g

    2. I’m with Kegan. I hate this route, but I think Ritalin three times a day is better than Trigen.

      Sadly.

  17. Thank you so much for this post and all the work you’ve put in. Trigen has been terrible for me and it was great coming across this post. Already filed a complaint.

    From what I’ve read here so far, it sounds like Trigen is near the bottom of the list of generics people do well with, but are there any generics that seem to be anywhere near the real thing? With the authorized generic off the table now, I want to see if any generics are worth trying before making a switch to name brand or another MPH altogether.

    Thanks!

    1. Thanks for acknowledging my work, Colin.

      None of the so-called Concerta generics will work as well as Concerta. That’s a given.

      Does that mean that none will work for you, as an individual? Nope.

      If it were me, I’d be busy trying some of the alternates in the MPH class.

      good luck!
      g

  18. Evidence of the proposed sale of Janssen’s Vacaville Plant:
    https://www.hgpauction.com/auctions/113590/janssen-vacaville/
    The auction ended Nov 30, 2022. I do not know what the results were.

    Like others, I am super frustrated at this whole situation. I am overwhelmed at where to start after having success with Concerta and some generic Concerta for over 20 years.

    I am 60, a full time family caregiver of my 89 yr old father who lives an hour away. The many “hats” I wear make me 10ft tall. I have extreme difficulty functioning without this medication.

    Any recommendations for a doctor in the NW Suburbs of Chicago? My primary care dr previously prescribed this for me for 20yrs. But at my last visit, she said, “I’m prescribing this medication for you out of the goodness of my heart.” That didn’t set well with me. So, not only am I looking for a new dr, I will be looking for a new medication.

    Anyone have success with Provigil or it’s generic (Modafinil, Armodafinil)?

    Thank you Gina for everything you have done and thank you for everything you are doing to help us!

    1. Hi there,

      “The goodness of his heart.” Wow. Don’t know whether to laugh or pound sand. 🙂

      You know, I don’t refer to anyone. It’s backfired too many times. Even to the “best” people. That said, I don’t know a skilled prescriber for ADHD around Chicago—or most other places.

      If I didn’t, I wouldn’t have worked so hard to empower consumers to “take charge” of their ADHD treatment with this step-by-step course:

      Course 2: Physical Strategies — Optimizing Sleep and Medication

      TO YOUR QUESTION: Anyone have success with Provigil or it’s generic (Modafinil, Armodafinil)?

      That is exactly why I created the course. 🙂

      Most people will not get the guidance they need from any article online or random opinion.

      I know of precious few people with ADHD who have found Provigil (or the other “ils”) helpful. They were introduced with a powerful marketing campaign years ago, but they did not live up to the marketing.

      If you did well on Concerta, I encourage you to stick with the methylphenidate class. There are many other options. I included some in this post…e.g.

      —Start Trying Other Brand Methylphenidate (MPH) Stimulants, If Possible

      Some brand medications have no generics yet. Therefore, it might be easier to get them over other brands for which we do have generics. (In the amphetamine class of stimulants, Vyvanse is one such example.)

      More points:

      I recently shared this updated post about two brand options (both of which offer savings programs),Liquid and Chew “Ritalin”: Quillivant XR & Quillichew XR.

      A new brand called Azstaryz is dexmethylphenidate, a tweaking of the methylphenidate molecule. Essentially, it’s a novel extended-release Focalin.

      Again, you’ll find in-depth medication details in Course 2: Physical Strategies: Optimizing Sleep and Medication

      —Check Out Non-Concerta Generic MPH Stimulants

      There are many generic methylphenidate options.
      Check out the generics for Daytrana (patch), Metadate CD, Ritalin LA, Ritalin SR. Methylin ER

      I hope this helps.
      Gina

    2. ADHDsufferer

      Hi DMO – I can recommend Dr Sawa and Dr Dhand in the Méridien Group in Chicago/Evanston. Appointments are currently Telehealth.

  19. Hi Gina,
    About Daytrana, do they make a generic form of the patch also? If so can you please compare what the generic patch contains vs the brand?

    1. Hi Marie,

      Yes, there is a generic Daytrana. I always recommend trying for the brand in any RX, if possible.

      It might be that you could get the brand, using the savings program. Just depends on your insurance policy terms.

      But if not, there is a generic.

      I have no information about how the generic Daytrana differs from the brand.

      The folks who have tried the generic recently upon my suggestion report that it’s working fairly well. The trouble is, none of them tried the brand previously. So there is no comparison.

      good luck
      g

  20. I started taking Concerta around two years ago now and was doing great on it, but this month I was blindsided and put on Trigen generic by CVS (not to mention that they tried to slap the name ‘Concerta’ on the pill bottle and charge me name-brand price for it- luckily I immediately noticed this and got the generic price). I am so glad to have done my research and come across this website explaining that there IS a difference between the two. I have often heard that generic is essentially the same as name brand, so when I started feeling worse soon after starting the generic I was worried that I was going to be dismissed. Now I feel like crying all the time without reason and I have no energy to do basic tasks that I’m normally fine doing. I have plenty of experience with clinical depression, so I am very vigilant in recognizing it, and I can tell this is an abnormal sudden turn in mood.

    This is all to say I feel a lot better and seen by reading these posts – and have scheduled an appointment with my doctor to hopefully work things out! Unfortunately, my insurance changed this year, and they’ve decided to no longer cover Concerta. All of this happening at the start of a new school semester is not fun! Fingers crossed I find a decent solution. 🙂

    1. Hi Allie,

      I’m glad you found my blog!

      Maybe your MD can help guide you, but honestly, many of my readers are MDs seeking guidance here. 🙂

      If you read the post, you’ll see that it’s quite possible Concerta itself is going away soon, too. So, the sooner you can start trying other options, the better.

      Several students in my course on ADHD medications have followed my suggestion to look into the generic for Daytrana patch. You wear it on the skin. But there are other options. I mention a few in this post.

      Good luck!
      Gina

    2. Allie – I have a very similar experience. I never suffered from depression until I spent a month on this drug. It kept me focused during the day but the come down in the afternoon was not worth it. I switched to amphetamines and they work much better for me. Unfortunately they are hard to come by these days though, you’re lucky to find them at the pharmacy.

    3. Hi CH,

      Just to be clear: Allie had problems with the Concerta generic, not the brand.

      So, when you say “this drug,” it’s unclear what you mean.

      At any rate, what works for one person might not work for another.

      For most people who do well on Concerta brand, these generics are often a poor substitute.

      g

  21. My new favorite thing is when I can actually find a pharmacy with ANY methylphenidate in stock, having them tell me they won’t fill my son’s Rx if he hasn’t already been filling there so they can conserve what they have for regular patients.

  22. In an earlier post, someone mentioned the generic by Camber. I looked at the prescribing information online and it looked similar to Concerta time release (more specifically pharmacokinetics), perhaps suspiciously so. Also, my local CVS may be able to get some. On the other hand, some disconcerting comments about Camber on the web, although none I saw specifically about methylphenidate extended release. Your thoughts?

  23. I so appreciate your blog and all your info — I’ve been following for many many years, back since Actavis was the official generic equivalent. I’ve often called our doctor after reading relevant info here, keeping him up to date, lol.

    I have twins who are 15, one of whom has been on Concerta since he was 5. His sister started taking a much lower dose at age 10. It’s been working great for both — we tried a few other things, none with much success.

    Now we’re scrambling to find an alternative, as brand-name Concerta is not covered by our insurance (I tried to get an exception — they’re not budging). Both kids have been taking Metadate CD (now just methylphenidate CD, I think) for the last few months while we couldn’t find Patriot. It’s not terrible, but it doesn’t last nearly as long, and having to take short-acting boosters after school is not going well. On the up side, we haven’t had worrisome side effects, either — it’s tolerated well by both.

    A friend said her son has had a lot of success on Jornay PM. Apparently you take it at night, because it doesn’t start kicking in for 10-ish hours? And then it’s supposed to last all day like Concerta, with smooth releases. Does anyone have further info? It’s worrisome that there is no dosage converter — should I ask the doctor to prescribe 20 mg pills, and then you take one the first few days, two the next few, etc. until you hit the correct dosage? From what I understand, most teenagers do best on 60 or 80 mg? That seems high, but I realize the dosage doesn’t compare to Concerta.

    Thank you again for updating us on what’s happening!

    1. Hi Tina,

      Thanks for letting me know my work has helped you and your family.

      I do think Metadate CD (brand name) might be a good option for many, especially those that need a “faster startup” in the morning.

      Here’s the thing….have you tried a second dose of the Metadate CD? Rather than “boosters” of something else.

      Most prescribers seem to believe that 1) 1 extended-release pill should do it!, 2) symptoms should be treated only for school/work….home doesn’t matter (yikes!), and 3) a stimulant in the system in the evening will interfere with sleep.

      Most extended-release pills don’t last as long as claimed on the package. That tends to be on the far end, and perhaps for slow metabolizers.

      Adding a “booster” of an entirely different medication means all kinds of adjustments in the body. The body likes homeostatis, not randomness.

      re: Journay PM

      I followed with interest its development. Asked more than my share of questions of the company’s conference exhibitors. I thought it might be just the ticket for lots of folks.

      Trouble is, I rarely hear from anyone who has tried it. Most prescribers don’t know about it. And, with things the way they are now — with Big Generic having taken over — I’m not sure it would be available to most people.

      But I think it’s worth a try.

      That’s exactly what it does. It hangs out in the colon, waiting for the outer layer to dissolve and kick in X hours later.

      I imagine it would take some trial and error as far as when to take it. Some will metabolize that faster, some slower.

      As for dosage….it’s just impossible to do conversions. The delivery system makes all the difference. I would treat it as if taking a stimulant for the first time — start low, titrate (increase) slow.

      That seems a little trickier with Journay PM. But maybe during a holiday week or the summer, you could do these trials.

      We definitely cannot believe the “average starting dose” bit. There is no average. There are only individuals with ADHD, some who metabolize fast/slow/average.

      I hope this helps. You might want to check out my course on medication and sleep.

      https://ginapera.adhdsuccesstraining.com/course-2-physical-strategies

      Sub-titled….everything you wish your prescriber knew or had time for but doesn’t. 🙂

      g

    2. Gina, thank you so much for your reply.

      From what I understand, brand-name Metadate CD no longer exists — it was discontinued several years back? I think only the generics remain, and I have no idea if several exist, and whether they’re bioequivalent.

      I hear what you’re saying about the “boosters” — I was under the impression that they are just short-acting methylphenidate, and thus the same drug as Metadate CD — so it didn’t occur to me that it would cause disruption. And I also never thought you could take a second pill of the Metadate CD — I will look into this and consider!

      I will also follow up if we try Jornay PM and share our experience. Thank you again.

    3. Hi Tina,

      Yes, Metadate CD went off patent years ago.

      I just continue to use the brand name because otherwise, the methylphenidate generics mostly all sound alike! Folks get confused.
      g

    4. Just a comment to Gina’s reply. For almost 10 years, My son and I both take a morning dose and afternoon full dose of Concerta. I may have a fast burn rate and I feel Concerta last around 6-7 hours. ADHD last all day… and I need symptoms relief for the entire day. 2 doses work great and I actually sleep better if I have a bit in my system… quiets my mind down. The only drawback has been insurance. Taking a morning and afternoon dose puts us both over the highest recommended dose. We had to get a PA and jump a few other hurdles but it has been worth it.

    5. Good for you, Sheryl. Getting what you know works—and falls in line with basic clinical guidelines—only makes sense!

      g

    6. Hi Tina,

      Back in late December 2022 through end of January 2023, my 15 year old son was taking Jornay 60 mg. Previous to this he was taking Concerta 36 mg. Did it help our mornings go smoother with getting him out the door on time for high school? Yes it did but we decided to take him off of it after 1) realizing it was making him argumentative at school with teachers and 2) after noticing that it was causing sleep disturbances and 3) he starting breaking out into rashes on his eyelid and inner elbow. We are currently back on Concerta until his rashes improve but will then have to figure out the next steps for which medication to switch to now that Concerta may no longer be manufactured.

    7. Hi Marisol,

      thank you for one of the few reports I’ve received on Journay PM. Sorry to hear it did not work for him. Rashes on the eyes….yikes.

      Is it possible the dose was too high?

      Let’s not count out Concerta. It is still being manufactured in Puerto Rico. So there is a possibility. Meanwhile, it’s important to document reactions to the alternatives he’s tried

      thanks,
      g

  24. I was googling my medication because I felt it had become less effective, and I just happened to find your articles…. Coincidentally, I switched to the Trigen generic a year ago due to insurance. Thank you for the information.

    1. Hi RM,

      Welcome to the ADHD Roller Coaster! I’m glad you found me.

      Kudos to you for noticing the difference and investigating.

      It’s really easy sometimes to attribute the change to other factors — more stress at work, relationship difficulties, etc.. The confusing irony is that a poorly working medication can CAUSE those issues. It gets messy!

      take care,
      g

  25. Aptensio XR was given to both myself and my son, it’s a poor substitute. My son was complaining two days ago that “his jaw hurt,” after many successful years with Concerta. I’ve been finding myself wandering in circles, getting off track. Yesterday I HALF made the bed then got involved with something else, also forgot to make my kids lunches yesterday. They were late to school on Monday for the first time in three years. I know that my significant other is also finding me more abrasive but he’s kind and hasn’t said a word.
    I’m supposed to take 3x 30 mg a day, according to my doctor, who has acknowledged that it won’t work the same. I normally take one 54 mg Concerta in am, and one 36 mg at noon. Taking 2x 30 mg aptensio at once did not work out! Yesterday I took one at 6 am, one at 9 am, and one at 1pm. That was slightly better, it wasn’t all “wandering in circles,” but it wasn’t exactly smooth sailing. I had trouble sleeping but could’ve been the extra coffee I drank to try to feel “normal?” Today I’ll try 6, 9, and 12. I used to take Concerta upon waking, but I meditate at 5:30am and this new medication is not (yet?) meditation-friendly.

    If one is prone to anxiety or obsessive recurring thoughts, I do not think you would enjoy this feeling. The only upside is that I was obsessing on the $ a former corporate client owed me since 2020. I contacted the CEO directly of this 2 billion dollar company (instead of the accounts payable department I’d been dealing with for months on end) and I’m finally getting paid today.
    I really hope we can get Concerta again. I need to pack to move myself and my two kids from the house they’ve grown up in, by June 1st, I cannot see myself going through all our stuff and staying on task like this. I’m also trying to expand my business and even sitting down to concentrate compose a compelling email will be a challenge.

    1. Hi Dari,

      I feel for you — and can only imagine how the change might be affecting you. And many others. But hey, you got that payment going! Still, maybe you could re-examine how you are taking the Aptensio Xr.

      One thing to know: Aptensio XR releases releases more methylphenidate in the morning (about 40%) with the remaining 60% a few hours later.

      By contrast, Concerta is slower to kick in and does so at a steadily ascending rate. Very smooth. Other Rx, maybe not so much. That’s the beauty of OROS, the osmotic pump that makes methylphenidate Concerta. That said, some folks need a bigger jump-start in the morning than Concerta can provide. So they might add a short-acting Ritalin or try another MPH option.

      HERE IS MY CONCERN: why does your doctor have you taking multiple doses only hours apart????? Aptensio XR is supposed to last 12 hours. While most extended-release Rx don’t last as long as claimed, at the very least it’s probably in effect for 6 hours.

      The doses do NOT translate as equivalent. That is, you can’t assume that 54 mg Concerta can be replicated with 60 mg Aptensio XR. Differences between delivery systems can create huge differences in how much — and how fast — the methylphenidate is released.

      Rather, a wiser approach is to start low and gradually increase, just as if you were first starting a stimulant. Because you are, a new stimulant.

      First, you aim for the dose that works best——for however hours it remains in effect. THEN you work on it lasting through the day, either by taking a second (often lower) dose or some other means.

      Good luck!

      g

  26. This is such a frustrating situation.

    Concerta worked super well for me and was a vital part of me succeeding in college last semester, but then it was suddenly taken off of my formulary and I was given Trigen. Trigen made me almost break down crying. It was the “same medicine”, but it basically felt like I wasn’t taking anything. I filed a report with the FDA, here’s hoping they actually care.

    1. Hi Gina,
      What do you mean exactly that Trigen is not bioequivilant to concerta? Are you saying that it does not contain the same exact amount of milligrams of methylphenidate? I am aware that it might not use the OROS technology and it might have different fillers, binders, colorants, and such, and that is okay with me since Trigen has been working for me for years, but I want to confirm with you that it still has the exact same amount of methylphenidate?

    2. Hi Tyler

      To understand bioequivalence, we have to understand generics. Specifically, what qualifies a drug to be a generic of a brand medication.

      It involves much more than having the same amount of active ingredient. For example, two medications can have the same amount of active ingredient, but the delivery system creates an entirely different effect — how fast, how much, over what time, etc..

      If you are content with Trigen, great. That’s really all you need to know.

      I’ve written much about bioequivalence in the context of Concerta.

      Here is an except from a post on generics in general (A Pharmacist Explains Generics):

      For a generic to be approved, it has to expose the body to 80-125% of the same medication compared to the brand (not other generics), as Gina referred to previously.

      This is calculated as the AUC (area under the curve). This means that as the body breaks it down, you can measure blood levels of it every hour until it reaches clinically insignificant levels. Add up all those levels for the brand and then multiply it by 80% and 125% to give you the range of what you need to see.

      The medication can give exactly the same curve, higher at times and shorter length of effect. Or it might give longer effect and lower curves or whatever combination that gets it within that range.

      For most medications, this isn’t significant, such as with Ciprofloxacin, whose dosages are 250mg and 500mg. But with medications such as Synthroid, which have very small increments, this can create a very significant response.

      For Concerta generics specifically: Consumer Q&A on Concerta Generics

      I hope this helps.
      g

  27. My doctor’s office recently sent out an email to patients about this issue. In addition to the known shortages, they mention that “recent reports from patients indicates many pharmacies no longer carry Concerta.” I think your tea leaf readings are very likely correct.

  28. For what it’s worth, I’ve been on Concerta for nearly 20 years, and in the past had trouble with one of the generics. I’ve been specifying Patriot for a while now and been fine, but I did try one other generic and found no difference for me personally.

    I just took out one of those, used a magnifying glass and then looked up the number, and to my surprise it is the Trigen generic.

    I know others have complained about those. Personally, I found no difference with that particular manufactured product.

    1. Congratulations! You lucked out, Andrew.

      You might want to ask your prescriber to note that on your prescriptions — and, for backup, ask your pharmacy to flag that preferred generic in your file.

      Here’s a little caveat, though….you don’t mention how long you’ve been taking the Trigen generic. But sometimes it sneaks up on a person. It might take a few weeks. And, in some cases, the difference isn’t always clearly felt by the person taking the pill. Rather, it’s by interacting with others.

      cheers
      g

    1. Hi Ethan,

      As I mentioned in the post:

      Overall, the tea leaves suggest that, with the authorized-generic Concerta has been eliminated, brand Concerta won’t be far behind.

      Just the tea leaves — extrapolations based on other data. No announcements.

      Then again, Janssen didn’t “make an announcement” about the AG being discontinued until supplies were almost out. And the “announcement” was very quiet — meaning, none except ADHD Roller Coaster blog readers knew about this several weeks ahead.

      If you’re taking Concerta and able to get brand, I’d keep with it. But, I’d also have an eye toward important “crunch periods” in the next year or so where being told, ‘No more Concerta” might really pull the rug out from under you — and plan accordingly.

      good luck,
      Gina

      good luck,
      Gina

    2. Hi Ethan, Gina, and all wondering about this,
      I called Jansssen a few days ago to ask this very question. Lady I spoke with (forgot to get her name ) said Brand Concerta is NOT being discontinued “as far as she knows.” That did not put me totally at ease, since she didn’t even seem aware that the Vacaville, CA manufacturing plant had recently shut down! However, she did tell me that Concerta is currently being produced at their plant in Gurabo, Puerto Rico. So maybe Janssen just moved Concerta production from CA to PR as a cost-saving measure, and there truly are no plans to discontinue? Here’s hoping.

  29. My son, got moved over to Metadate CD. He is only 14 and has doesn’t really know what he takes. He also has the mindset of ‘ just give me what I am suppose to take and I will take it”. and we haven’t told him about the change as we know he will fixate on it. He is strong on advocating for himself though, so we have few worries. So far, so good.

    1. Hi T,

      That’s wonderful. I hope the transition remains smooth.

      One thing….it’s important to remember that ADHD can mean not noticing details, and if the medication isn’t working effectively, they might not know what they’re not noticing. 🙂

      It’s good to have objective rating scales, treatment goals, etc… something to measure it by.

      g

  30. Wow, Gina, thank you for all your work. I’ve read your “Is it you, me or ADHD” book, so amazing! If only I found it before my ex husband had had enough! Oh well, his loss….
    Also unfortunate, I didn’t find your blog until yesterday, when my doctor explained that Concerta is no longer being made. I feel like someone from Kaiser should’ve given us a head up! I’ve been on it for 11 years with great success. I have no idea how to successfully parent without it. Running my business, with my already problematic administration difficulties, is going to be exceptionally challenging. I’m afraid but not (yet) panicking. My 16 year old son also has been taking it for 3 years now. I would’ve at least had us taper down if I had known, or at least conserve and not take it over breaks and vacations. Tomorrow I get to spend the day getting in and out of the pharmacy line at Kaiser, while my doctor and the pharmacist discuss comparable medications and their availability.

    His girlfriend asked what we’re going to be like now, I said “we’re going to be a lot more fun!” Not sure if will be as much fun for everyone else, though. We both have certain odd behaviors, like repeating what people say on tv, when unmedicated. I never realized it until my boyfriend pointed it out, he will gently say “did you take your medication?” Now we can just say, “nah! They don’t make that sh*t anymore!”

    Jokes aside, thanks for all your work. I’ll keep digging and hoping for a suitable replacement.

    1. Hi Dari,

      I’ve always found that a sense of humor — and appreciation for the absurd — can get me through a lot.

      NOBODY gave a warning. Not Kaiser. Not “ADHD websites” Nobody. Only me. Not to toot my own horn but that’s the fact.

      I tend to see consequences far down the road. Thanks for noticing my efforts here!

      You might not want to leave it entirely up to KP and your doctor (unless you really trust your MD).

      Check out some that I mention in the post. Most prescribers seem to know only Ritalin, Concerta, Adderall, and Vyvanse. There are many other MPH medications, some of them brand with no generic — and with savings programs.

      good luck!
      g

  31. Thank you for all your help with keeping track of what is going on. I am so confused whether to keep my son on Concerta or not. Can someone confirm Janssen, not Patriot, is also looking to stop selling Concerta. I am going to have my son start on a medication and get used to it and then having to switch. This is crazy. Any comments would be super helpful

    1. Hi Aron,

      It’s best to read my post—or ask me. Sometimes reader comments are accurate and sometimes not. 🙂

      We have no firm word on whether Concerta brand will continue or not. That is not forthcoming from the company or elsewhere. The best we can do it keep reading the tea leaves.

      Anything can change at any time. For the time being, it might be best to go with what works well and what is affordable/accessible. If that becomes unavailable/unaffordable, then you can look elsewhere.

      Changing medication isn’t always a huge deal, and there are many choices in the methylphenidate class.

      ]A different medication might work better in some ways, not as well in others. It’s always a balancing act. That’s why it’s good to have a trial of each class of stimulant—and sometimes more than one choice in each class.

      The main issue with Concerta is that its generics do not work as Concerta works. For some people, one of the generics might work better FOR THEM than brand Concerta does.

      To clarify one of your points, just in case: Janssen IS Patriot. Patriot is the division of Janssen that sold the authorized-generic (brand sold as a generic, through a marketing deal that postponed the first Concerta generic entering the market).

      It might be helpful for you to learn more about the different choices and how to target treatment goals. Here is my course on that topic: https://ginapera.adhdsuccesstraining.com/course-2-physical-strategies

      good luck!
      g

    2. Dear Gina and everyone,
      Just to be clear , as the reader who initially commented that the Alza plant was shutting down and I wondered if that meant Jannsen was going to discontinue Concerta altogether, I had no info besides that they were shuttering the plant! I wish I could find more info on that , but I cannot. I also feel like briefly I saw Gina had posted something more definitive on the fate of either Concerta itself or the alza plant latest news but now I don’t see that anywhere. I am in the same spot as others here— a consumer trying to figure out what’s happening! I try to do some internet “ research” but have no sense of the industry beforehand and value and rely on Gina’s great handle on things— I just want to be clear that I too am only providing “ tea leaves “ I come across and never meant to imply I “ found “ that Concerta brand is being discontinued. There are just some weird concurrences and I indeed am worried they will and so ask if that may be on the horizon hoping that anyone with more information or knowledge about how to get it might lead us to the answer! Good luck to all in this !

    3. Thanks, M. I think you were cautious in sharing those news tidbits.

      Some folks are panicking. It’s understandable.

      Unlike Janssen, I like to give folks a heads-up. To just be aware.

      tx
      g

    4. Dear Gina and all,
      I am hoping that someone else is “ allowed” either via a new patent or “deal” with Jannsen owner of Alza and thus their OROS tech patent, to get that good Osmotic action into adhd meds . Feels like it should be doable and for Jannsen to quash it in any way feels wrong at a level beyond just Investigating Adhd meds maybe.
      But again I am speaking as someone who is not familiar with the pharma world ( but feel like I need to try just to advocate for my family members given that apparently we are on our own in the wilds of capitalism before patient care!)
      Good luck to all in this!

  32. Thank you for all of this work. I started taking methylphenidate last January and been on 54mg for most of it. I didn’t pay much attention to the drug manufacturer because I pretty much limited to generic anyway. I think I was mainly getting Teva or Trigen. My last refill in December took weeks due to shortages and I got Patriot, which I found rather ironic. I just wish I knew from the start that there was so much variation.

    1. Hi J,

      It’s scandalous — how much prescribers don’t know, how much the commercial sites exploiting the “ADHD market” don’t tell you (most of them promote a non-methylphenidate-producing pharma, which funds them), etc..

      I’ve seen the difference that being self-educated makes. It’s absolutely necessary for everyone taking ADHD Rx.

      I finally created an in-depth course——with printable charts, guides, etc.——to help folks with ADHD optimize their medication and address ADHD-related sleep challenges.

      The hot mess I see out there just nauseates me. Folks deserve better.

      https://ginapera.adhdsuccesstraining.com/course-2-physical-strategies

      take care
      g

  33. Hi Gina,
    Replying to your 1/18 post re: how corporate communication has changed for the worse since the 90’s…
    When thinking about how to get the word out re: Janssen leaving untold numbers of people stranded without the medication they rely on, and how we measly consumers/patients seem to have no voice or recourse, it occurred to me…..what about using that forum that has recently been re-opened to actual FREE SPEECH, i.e. Twitter. Whatever one’s opinion about Elon Musk personally, there’s no denying that he is working hard to uncensor and bring back voices that had previously been blocked, due to being “inconvenient” for the “powers that be.” (whether they be Government, Big Pharma, or any other entity.) I am not on Twitter, but for those that are, how about blasting Janssen with some outrage over this situation? Maybe that would get their attention, or at least make others who could possibly help aware of the situation. It is unconscionable what they are doing, and the word needs to be spread as far and wide as possible!

    1. Hi Ann,

      I figured that public shaming on LinkedIn — where other businesspeople, scientists, physicians, etc. — would be more effective. Also, I use my FB page, as it is public and comes up in searches.

      On Twitter, it would just make everybody angry and resorting to angry platitudes, “Curses, Big Pharma!” 🙂

      Personally, I’ve always found Twitter a bit of a sewer — full of trolls and hotheads — though I know some folks really like it and they find community there.

      I don’t have time for more fractured nonsense. Trying to explain an extremely complex issue in a few words.

      “Uncensored” means that any crank or propagandist (take identities galore) can say anything. That is not what the free press or free speech is all about.

      I find Musk’s behavior sociopathic and toxic. I would not support him in any way. These tech “titans” are at the forefront of eroding civility and distorting information.

      But hey, you can try it on Twitter! 🙂

      g

  34. Sorry it won’t let me reply to your message, so had to do a new one.. I work in pharmacy obviously I’ve heard about the Janssen generic being stopped, but nothing about the actual Brand name Concerta being discontinued, nor has anyone else in my very large pharmacy group.. can you send me the link you are getting this info that the brand name is being discontinued.

    1. Roxi — You’re not going to find announcements like that. Companies don’t bother thinking about consumers anymore, even consumers who’ve made them fortunes over the years.

      And, thanks to Google, Facebook et al, newspapers don’t have the staff to cover these issues.

      Instead, we have to piece together bits of information.

      I wrote in this post:

      Update:  A kind reader points us to this article, indicating that Janssen parent company J&J started scaling back production at its Alza plant in 2019.
      Excerpt from FiercePharma’s Janssen Laying Off 4 Dozen Employees as California Plant Heads Towards Closure:

      J&J says the closure is part of an effort to rework its manufacturing network as its drug portfolio changes.

      “As part of this transformation, we will scale down production at our Vacaville, California facility with the intent to fully exit the site by the end of 2022,” J&J spokesman Matthew Johnson said.

      Janssen, like other drugmakers, is putting more effort into areas such as immunology that involve biologic drugs.


      At the same time, from what I can tell, Janssen is still manufacturing Concerta at its Puero Rico plant.

      g

    2. Wow Gina on the 1/18 end-of-day post on this reply chain, so beautifully expressed .

      So have you waded in the swamp of patents documents at all lol?!
      I just started on that for fun, imagining that I’d seen someone somewhere I can’t recall implying Alza’s OROS patent was over soon. I don’t know when the original was done, but they clearly game the patent system in a big way and visibly so in their documentation for their 2013 renewal essentially of their OROS delivery system, which seemed to come with lawsuits against multiple generic makers presumably trying to make delivery systems like theirs . The lawsuit parts are hard to parse because they are purposely vague of course, but wow disgusting. From the patent pdf references it almost looks like some of the manufacturers of the pulled generics were trying to make a decent osmotic system ( which they would reasonably want to do, right, to put out a truly therapeutically equivalent product) and Alza said that’s infringement and also renewed/extended a patent by saying we are now moving from bilayer form to trilayer and we backwards claim
      All previous tech we had patented ( but that now has expired) to be included in this new patent and so nobody can mimic it .

      https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/9000038

      The title of the patent also seems anachronistically vague and really feels scandalous :

      METHODS AND DEVICES FOR PROVIDING PROLONGED DRUG THERAPY

      Like huh lol? In 1965 maybe but in 2013?!
      No wonder an “agreement” was reached between a generics maker and Jannsen to market and make some easy money off the brand marketed as generic so they could staunch the bleeding of lawyers fees on this patent bs . I mean , it might be slightly more expensive or complicated to make their osmotic system but I would guess even generic makers would like a shot . I have to re-read all the timeline of the initial off-patent shenanigans you chronicle and see how this patent fits in lol, it doesn’t look like the other patent filings I’ve been looking at but I’ve just started ( wordle is only once a day after all!)

    3. Interesting!!!

      Yes, Janssen entered that marketing deal with Watson — forestalling its Concerta generic by allowing it to sell the authorized-generic.

      Watson to Actavis to Teva. I suspect Teva’s generic is that developed at Watson. But who the heck knows what’s happening in this giant shell game.

      https://www.ftc.gov/legal-library/browse/cases-proceedings/1210132-watson-pharmaceuticals-actavis-inc-matter

      I am so immersed in course-creation and delivery, answering e-mail, facilitating groups, and blogging…..can’t get distracted even more than I am with the granular bits. But I appreciate you sharing this!

      Given what you write, I find a bit ironic that Silicon Valley’s 800-pound gorilla IP law firm, Wilson-Sonsini, now occupies the real estate where Alza used to be!

      g

    4. Good luck with all those spinning plates and thank you for your very important work! Wow on the Silicon Valley law firm thing how ironic! The business journalist community there must be very interesting indeed!
      Maybe not at all ironic actually , maybe they are setting up there because they are so close to the action that Alza /Jannsen/new biologics-focused J&J represents that it makes most sense for them to be literally in the room. To guide the development of IP itself essentially, to strategize for ROI in a big picture (collusional) way. Given that VC and PE have consolidated so much, Lord only knows how much development is micro managed in ways we never ever get to see, and they can be even closer to that if they sit at the incubator, which is what the local commerce boards have invited in to replace their “legacy “ old school businesses “merely “ taking care of patients pill needs :/

    5. M – the business journalist community here is non-existent. Mostly lapdogs and sycophants.

      Google, Craigslist, Facebook et al killed newspapers, especially local papers. Silicon Valleyites tend to view news as “free”, not stopping to think who is funding the free and why. Or, they find national newspapers/issues sexier than local news.

      To be clear: Alza (“the first independent drug-delivery company in the world”) vacated years ago, almost 30 years after being established, in 1971. JNJ acquired Alza in 2007.

      Yes, whole lot of skullduggery going on, and NO watchdogs.

      g

  35. So are they getting rid of the Concerta brand name discount card? I keep reading conflicting info and I just used mine 2 days ago. Granted it didn’t cover as much cause of the coverage my insurance provides and I had to pay $50 for it which is fine. But just wondering if they are getting rid of the card?

    1. Hi Roxi,

      No word about the card yet. But Janssen is phasing out Concerta, period. Don’t know when exactly but it’s expected this year.

      So that means no savings card when Concerta is no longer sold.

      g

    2. So Gina, I’m confused.

      I thought the Authorized Generic was no more in 2023. But I also thought that Brand was still available IF you are willing to pay Out of Pocket since MOST insurance companies have removed it from Formulary list. Did I miss something?

    3. Yes, LBS, the brand is available for now.

      But reading the tea leaves, including gradual staff lay-offs at the Alza manufacturing plant, it’s not looking good.

      Initially, I thought it might be sold. But thanks to “Big Generic,” that might not be feasible.

      With the patented OROS system that makes methylphenidate Concerta no longer made, how can Concerta be produced?

      g

    4. Hi all and Gina!
      I am that reader who had found tidbits about the Alza plant closing but precious little besides the trade mention here and news from Vacaville economic development folks

      https://solanoedc.org/news/vacaville-stepping-up-its-biotech-attraction-and-retention-efforts

      https://www.dailyrepublic.com/all-dr-news/solano-news/vacaville/vacaville-enters-2nd-phase-of-its-biotech-attraction-initiative/

      who just formed some sort of ( no doubt VC backed ) non-profit to start a biologics incubator to make up for the loss of jobs from Alza and other traditional pharma production that the area had relied on. Private Equity and VC and the massive amounts of secretive capital moves they represent are at the base of the problem here i think — pharma has no need to care about patients and the corporations don’t even need to care about their relationships with other corporations because they are all owned or incentivized by giant capital groups who decide “ what’s hot”. What I can’t find is confirmation of what is happening to the Alza plant?

      So, did you get rumor mill confirmation that Jannsen is ending Concerta altogether? Is it maybe Related to that Relexxii approval as an RLD when it’s just Osmotica “Osmodex” Concerta?! They got the initial RL for Relexxii first as “ the only 72 mg ER methylphenidate “ and then got approval just months ago for the other Concerta dosages it looks like and now all those generics will be generic for Relexxii! That was vertical pharma for initial RL approval of the 72mg ER, then they merged with Osmotica and now all owned by Avista partners, who I haven’t researched further for implied roles in all this mess but would not doubt if they were!
      Soooo big generic wins again because if they announce Concerta is being discontinued so sorry we’re focusing on biologicals you folks are fine because look over here there is a newly approved brand called Relexxii! Docs already know it from the 72mg and now we’re expanding to all the Concerta dosages and we’ll give you a savings card! The question I have is if they will also pull the existing generics for Concerta? I see Adhansia XR was pulled before it had generics but for example Metadate CD was discontinued for brand but there is still generic formulations available. I’m not sure when Metadate was pulled as brand and if generic makers tend to pull their generics after a while if the brand is discontinued.
      It leaves me wondering also about Alza . There are other drugs that use this system and should not it be a patent that expires at some point? I think I saw some news about that on a patent website but it looked like they were being given options to extend it? It would be so awful if Jannsen keeps the patent for a truly good OROS system just to “kill” it via insider agreements gaming the markets for their profit !! I fear that too is happening.
      Biologics are so “hot” right now that when I called a pharmacy today to ask about adhd meds we got to chatting and he told me oh he has to get a second refrigerator because the increase in the use of biologics is insane!

    5. Interesting, “kind reader”.

      What to make of it? I have no idea.

      Figure out one thing and that will change, too. It’s like a giant game of Whack-a-Mole, with ADHD patients as the moles.

      I’m old enough to know how aberrant and sociopathic this is, and I wish I wasn’t.

      g

    6. Ugh, dear kind Gina, it really does feel like whack-a-mole !
      The execs probably actually orchestrate that part as well so that we moles are too disoriented to even work out what to pursue in terms of remedy or complaint :/
      Good luck everyone and I am grateful we have at least some forums for sharing stories and info thanks Gina!
      It’s definitely sociopathic but did you mean aberrant even for the sociopathic orchestrators of pharma profits lol? Like, this is bad even for them, and maybe there is some investigating /complaining to be done (knowing of course that drugging kids isn’t a popular banner to wave for Congress people)? Or just abhorrent, which it is clearly also :/

    7. ha. You’re right. “Big Pharma” hasn’t exactly been choir-boy material. But despite all that, many people have benefited from life-enhancing and life-saving medications.

      I know scientists who work in pharma. They are very driven by helping people. It’s sometimes a bit different in the marketing-sales-strategy-whatever departments.

      But I mean all of it…corporations everywhere. I started noticing it when I moved to Silicon Valley. I’d been managing editor at a business paper in Southern California for several years. I was familiar with the way things worked then (early 1990s).

      What I saw here, with the exception of old-school companies such as HP, was outrageous “I’ll do what I damn well want” behavior from rest of the tech sector. They put up their communications firewall. They’ll call you. You don’t call them. It was definitely a departure from standard practice. But now it’s become the standard.

      Corporations make it impossible to contact anyone in the company. About anything.

      Thanks to Google (and before that Craigslist) and Facebook and….newspaper advertising was decimated. Especially classified ads, the bread and butter for many local papers. People thought they could get “news for free” and so didn’t subscribe and support local papers.

      Companies got accustomed to never being questioned by the media, no stories written about them — except in the most egregious cases or in the industry rags’ softball stories or financial market analysis. They don’t even pretend to have a media contact any more.

      So, yes, more sociopathic than they used to be — and more “in-your face” about it.

      I’m totally behaving badly on LinkedIn. lol. I don’t care. I’m going to raise questions wherever anyone will listen.

      We have precious few outlets these days, thanks to the Masters of the Universe. To see there self-congratulatory post after post from Janssen….I should say press release after press release…. my nausea hits tolerability limits seeing all those smiles and reading all the platitudes. And I hear my Italian momma’s voice: “BASTA!” (Enough!)

      Sorry, I’m a little amped up. The local Adult ADHD group just ended. I never stop seeing the real-life fallout — from reckless prescribing to these pharmaceutical shell games — and it pi**es me off. 🙂

      cheers
      g

  36. Do you have contact information for the Janssen/J&J execs who made this Concerta Alza Generic business decision without consideration of the patients?

    1. Unfortunately no, DJ. Corporations these days have heavily defended access — and no longer have media contacts. Unless it’s for financial reporters, I imagine.

      It’s all disgusting and slimy.

      g

    2. Jennifer Taubert
      Executive Vice President
      Worldwide Chairman
      Pharmaceuticals
      Janssen Pharmaceuticals

      Vanessa Broadhurst
      Company Group Chairman
      Global Commercial Strategy Organization
      Janssen Pharmaceuticals

    3. Hi Laura,

      I could find their names but not the contact information. Did you see that?

      I did send a mail to media relationships weeks ago. Still waiting.
      tx
      g

    4. Look at Johnson & Johnson’s SEC filings. About J&J. Our Leadership Team. 10-Q filing shows corporate address as:
      One Johnson & Johnson Plaza
      New Brunswick, New Jersey 08933

    5. Sorry to be unclear, Laura. I found the corporate address for Janssen but was trying to find more direct contact information.

      If readers would like to write the behemoth J&J, they can have at it. But I can’t imagine anyone will even open the mail.

      This is the stated corporate headquarters address for Janssen:

      1000 Route 202 South
      Raritan, NJ 08869
      USA

  37. From the Janssen website: “Beginning January 1, 2023, patients that have public or private insurance will no longer be eligible for the JJPAF program.”

    1. The savings card is still in effect; however, the max benefit is $150. Last week Walgreens quoted me a price (with insurance) for non-generic Concerta of $150. I called this week and they said there was a price increase and it is now $300!

    2. Wow, Jackie.

      Sounds like price-gouging — but where does it originate? Maybe try another drugstore? Did you check local prices on Goodrx?

      Might be time to try another methylphenidate formulation entirely — there are lots of them. Some are brand.

      I’d say we need a congressional investigation about all this mess but unfortunately, “drugging children” is not a popular thing for politicians to do.

      good luck,
      g

  38. I’m about to pay $428 for brand Concerta because my insurance company refuses to cover any portion of brand Concerta. Unfortunately for me I tried other ADHD medications and Concerta has been the most effective for me. It took months of trial and error to settle on Concerta about 6 years ago. I’m so disappointed with my my doctor’s office bc they apparently cannot or will not properly complete the prior authorization paperwork. My next step is to go back to a psychiatrist to try to find a new ADHD medication.

    1. Oh boy, and you can’t use the savings coupon?

      A few new formulations have come out in the last six years.

      good luck,
      g

  39. My daughter has been on concerta since she was 12 years old. She is now 33 and pregnant in her first trimester. Her doctor wants her to take a different drug. Sorry I don’t know the name. He even gave her a coupon. The pharmacy said that they can not fill the script with out without the coupon because her insurance company refuses to pay for it. At any other time in her life I don’t know if I would be concerned as I am right now because she is pregnant and we don’t know how this is going to affect the fetus.

    1. Hi Karyn,

      I understand your concern.

      She is unable to get brand, at an affordable cost?

      Many women with ADHD choose to stay on a stimulant during pregnancy, though this is more common (and considered more prudent) when it’s an MPH stimulant, not an amphetamine.

      ADHD neurobiology is about more than focus. There are many downstream physical effects from untreated ADHD — and from treated ADHD. It depends on the individual.

      Sometimes the lowered functioning (without Rx) creates more danger to the mother and fetus than the medication.

      g

  40. I only managed to get my diagnosis and first prescription last June. I’m in the latter half of my 20s. I had no idea that all this very well could be a contributing factor to inconsistencies I’ve experienced over the past several months since I started this medication. I’ve had one prescription filled with the alza barrel-shaped pills. Prior to reading various pages on your website, I thought there was no difference in operation between the medications, but because of my lack of awareness and the limited span of 30 days with the authorized generic… I have no reference point to accurately compare my experience between the two. I can, however, definitively say that this more than likely explains the varied results I’ve had with this medication, even when I have been keeping up with my self-care.

    Please let me know if there’s anything else I can do to help beyond filling out the FDA complaint form.

    1. hi Leica,

      I’m afraid most people don’t realize this, that generics aren’t always “bioequivalent.”

      Neither do many MDs and pharmacists.

      It’s gotten so bad now …

      Stay tuned in case I get any other big ideas on actions we can take.

      Cheers,
      G

  41. Unfortunately, Quillivant and Quillichew are also not covered. My insurance covers NO brand name ADHD med. None at all.

    Physical strategies and coaching are useful as an adjunct to stimulant meds but do not work on their own. The meds are needed to get to a state of focus where coaching can start to help.

    1. Hi again, BKM,

      Unfortunately, that seems to be the trend….no coverage of ANY ADHD brand medication.

      There still might be generic options, though. For example, Daytrana (the patch) is now a generic. Metadate CD is a generic. And there are more.

      g
      P.S. Preaching to the choir there on physical strategies and coaching being of little use without meds “on board.”

  42. I have two kids who have been on Concerta 54 mg for years. We used generic versions most of this time because under my insurance I only had to pay $10 for the generic compared with $60 for brand name Concerta. I have no idea which generic was being used, whether it was the Janssen one or one of the cheaper ones, because my kids were doing fine on it.
    But in November, I went to fill my daughter’s prescription and was told by my pharmacist that he could no longer get any generic and had to fill with brand name Concerta. Fine, we sucked it up and paid the higher co-pay. Same with my son who uses a CVS in NJ – no generic available, so we ponied up for the brand name.
    However, my employer switched insurance plans effective Jan 1, and the new plan no longer covers brand name Concerta AT ALL. I have no idea what to do. The pharmacist says to get the doctor to write an appeal, saying that my kids need the brand name Concerta. But I don’t see how the doctor can do that because the issue isn’t that my kids can’t use generics, it is that there are NO generics to be found. We are desperate. My son, who is in college, will probably have to take a health leave of absence if he can’t access effective medication, and I don’t know what will happen to my daughter who is in HS- she is pretty much nonfunctional when off meds. Do you have any advice?

    1. Hi BKM,

      It’s so horrifying, thinking of how many people are in similar situations right now.

      I imagine pulling a drug with such huge market-share is sending customers to the dwindling supply of Concerta generics.

      As I wrote in this post, the best we can do now is look into other methylphenidate medications. There are many.

      excerpt:

      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)

      You still might want to get started on that appeal, as production ramps up with the other generics. Typically, it’s necessary to at least try the covered generic — in order to report on the effect.

      g

    2. BKM- I’m in the same situation with my college age boys. I contacted insurance and asked for an override due to the shortage of generic concerta. The rep said they are approving a lot of requests as they are aware of the shortage. The dr had to write the prescription for name brand no substitutions. I was able to get it but had to pay the highest copay. The insurance may tell you it’s not in the formulary but don’t give up and continue to insist on the override.

  43. Shame on me… I had no idea this was happening amidst the holiday rushing around. In addition, my employer switched up our healthcare and scripts so we have no recourse, it seems. I had been successfully getting my daughter’s Concerta ER filled with Patriot for years now thanks to your advice and blog. Our Ped sent the script yesterday and I received a call from Express Scripts this morning saying they have no Patriot to fill it – the only generic they have now is Trigen, and I’m almost positive she’s tried that in the past with sub-par results. So, I asked her if I can switch to brand/formulary only – of course she was a pharmacist and told me to go online to check or call customer service. Sure enough our new plan does not cover the brand AT ALL. Out of pocket cash price for me is a bit over $1,300 for a 90 day supply. That won’t go against my healthcare deductible though, because it’s not covered at all. I don’t know whether to try the Trigen generic or to start the try-them-all-merry-go-round process again to find something new. She’s been on Concerta ER for 4+ years now with a couple dosage increases but works super well compared to everything else. 2023 is not starting great in our household, to say the least!

    1. Hi Misty,

      I first posted about this on 12/1, which of course was just a horrible time to begin figuring this out. The holidays approaching, kids out of school, etc.

      I encourage you to look at your Rx purchase records, to see for sure which other MPH Rx might have been tried. You might be able to use that, noting particular adverse effects, to ask for an exemption and get brand Concerta.

      But also, instead of looking at Concerta generics, I’d look at other brand MPH drugs, as I mention in the post.

      It might be that Trigen (if you haven’t already tried it) or another of the Concerta generics will work well for your child. But there’s something to be said for a brand medication, even of another type.

      With generics, there are often different colorants, binders, and fillers than with the brand; many folks with ADHD are sensitive to those. Plus, the dosage allows a wide margin of error. That’s a problem because most ADHD medications are more effective with precise dosing.

      That said, insurance coverage is increasingly eliminating brand-name Rx.

      good luck. I hope you find something better than Concerta!

      g

Leave a Comment

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

[advertising; not endorsement]
[advertising; not endorsement]
Stay in Touch!
Ride the ADHD Roller Coaster
Without Getting Whiplash!
Receive Gina Pera's award-winning blog posts and news of webinars and workshops.
P.S. Your time and privacy—Respected.
No e-mail bombardment—Promised.
No Thanks!
close-link