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 at least five 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: Some Consumers Get Exceptions, Etc

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 in the Meantime”  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. 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, Concerta has become much 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
  • 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.

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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. 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.

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