Concerta manufacturer Janssen officially ended availability of its authorized-generic mid-January 2023, through its Patriot subsidiary. (What’s more, some evidence points to Janssen phasing out Concerta brand entirely this year, 2023. Stay tuned.)
Shocking, I know. Concerta users accustomed to paying generic prices, however, were feeling this decision as early as October, 2022.
As ADHD Roller Coaster blog readers know, the authorized-generic is the brand; it’s only sold as a generic.
Now, with Big Generic seemingly driving—and in some cases even colluding with—insurers and pharmacies to eliminate access to many brand medications, getting even the brand Concerta is difficult for many consumers. I offer tips below.
You can also listen to the podcast version.
ADHD Roller Coaster readers have followed my posts about this ongoing story since 2014. Many followed my suggestion in filing FDA MedWatch complaints. That resulted in the FDA downgrading the first two Concerta generics as non-bioequivalent. That is, not close enough to Concerta.
I’ll link to my most popular comprehensive post at the end of this one. Much of it no longer applies, but it will be helpful toward understanding the complexity of generic medications.
Overall, the tea leaves suggest that, now that the authorized-generic Concerta has been eliminated, brand Concerta might not be far behind.
I encourage Concerta users to start looking into alternative stimulants. Now. Don’t know what they are? That’s a common problem.
In addition to other factors, most prescribers seem familiar with only 2-3 stimulants. Currently, two of those are in shortage, Adderall and Concerta (along with Ritalin products). Vyvanse appears to be available as usual.
Moreover, pharmacy-benefit formularies (that is, what’s allowed) vary widely. Increasingly, brands are inaccessible.
I find all of this unacceptable. We should see a congressional investigation. That’s unlikely, though, given stigma around ADHD.
For 20 years, I’ve listened to prescribing-gone-wrong stories with great frustration. The hard truth is, a huge number of prescribers are not skilled. That means you don’t get the results you hope for, and that’s a shame.
I created this course to take you by the hand, step by step, so you can confidently self-advocate with your prescriber and optimize medication and sleep strategies: Course 2: Physical Strategies
More In This Post on Concerta Generics:
- What’s the upshot?
- What does this mean for consumers?
- Other ADHD medication shortages
- Try not to panic
- Tips in the meantime
- Big picture – the changing Concerta landscape
- Why Concerta users have been fortunate for years
- Report adverse events to the FDA
- Janssen executives – leave a message for them if you like!
- My comprehensive post on the Concerta generic issue
1. What’s The Upshot?
The Patriot authorized-generic for Concerta discontinuation notice was finally posted on the FDA website 12/9/22, two weeks after I posted the original article.
On Dec. 2. a Janssen 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.
Janssen would not indicate if Concerta brand prices are being negotiated. Rumors have circulated that J&J/Janssen might sell Concerta to another company. I’m not sure how that company would fare any better, competing with a slew of dirt-cheaply made generics. I’ll let subscribers know as I learn more.
A kind reader points us to one data point that casts doubt on Concerta’s continued manufacture. It indicates 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. That means dropping people with ADHD metaphorically on their heads.
2. What Does This Mean for Consumers?
What does this mean for consumers who have relied on this ADHD stimulant medication for years. Including my own husband?
That depends on many factors, including:
- Insurance pharmacy benefit terms (fewer are covering brands these days),
- Symptom severity and co-existing conditions
- 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, its way past time we make our voices heard. We did it in 2014, so let’s try again.
3. Other ADHD Medication Shortages
This turnabout has been made worse by an overall shortage of stimulant medications, including the Concerta generics and Adderall.
- The ongoing surge in diagnoses thanks to COVID pushing long-lingering issues to the fore.
- The U.S. Drug Enforcement Agency (DEA) limits stimulant raw materials annually. Has the DEA increased limits due to the increase in diagnosis? I find noevidence of that.
Bloomberg reported on this 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. 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.
4. 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.
- It’s always tricky this time of year, as stimulant raw materials run low, thanks to the DEA’s arbitrary restrictions.
- Some supply issues might resolve by January.
- We just don’t know what Janssen might do in 2023 in terms of making the brand Concerta more accessible and affordable. What deals it might be cutting with pharmacies and insurers—or sale of the drug to another company. But, as I mentioned above, shutting down the Alza plant does not look positive.
To find more details, I made multiple phone calls to multiple offices at Janssen and parent company Johnson & Johnson. No response. (Companies don’t have to respond anymore. That went out with the flood.)
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
Don’t understand what’s the big deal?
Someone wrote on my Facebook page: “I like the Trigen, Gina. Concerta is not the GOD of stimulants.”
Trigen’s generic for Concerta is one that 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. That reader assumes she has a handle on what’s happening—and she clearly doesn’t.
Moreover, I never claimed Concerta is a GOD or in any other way superior to other stimulant choices. I claimed only that it is a very popular choice that millions have relied upon for years—and they are losing it without a likely replacement.
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, 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 inferior products from “Big Generic.” Pharmacies and insurers probably make money selling these pennies-to-produce generics made in India and elsewhere. Learn more more history here: Authorized-Generic Concerta Update.
5. 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.)
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
- 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, but now it doesn’t even list it or the authorized-generic as an option.
—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.)
- 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
—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.
6. Adverse Reaction? File an FDA MedWatch Complaint
This is how we got the first two inferior Concerta generics downgraded. 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
7. The Changing Concerta Landscape
In the past, consumers could more easily switch to brand Concerta. They’d pay the brand price, of course. Yet, depending on insurance coverage, it would be maybe 3-5 times the generic price. That is, more like $100/month, not $600/month. Even less with the home-delivery 90-day pharmacies.
Then everything changed. Beginning in 2017, “Big Generic” unleashed a slew of non-bioequivalent Concerta generics. Many are produced for pennies, some in poorly regulated Indian and Chinese factories. If your insurance coverage specifies generic (if available), that’s what you might get.
Even with insurance coverage that previously covered brand, soon that wasn’t an option, at any price.
Fortunately, Janssen continued to make available its Concerta authorized-generic. With a bit of effort—and guidance found on this blog—many consumers succeeded in getting brand Concerta at a generic price. But insurance companies and pharmacies paid a higher price, compared to the inferior generics.
8. Concerta Users Have Been Lucky Thus Far
In a very real sense, we’ve been fortunate to have had the Concerta authorized-generic (brand sold as a generic) for so long. It seems unprecedented.
This is partly due to Concerta’s sophisticated delivery system, using a proprietary osmotic pump called OROS from Alza. Without OROS, Concerta generics are basically Ritalin generics. (This is why news of Janssen edging toward closing the Alza plant likely means no more Concerta at all.)
That’s why the FDA downgraded the first two inferior Concerta generics, thanks in large part to ADHD Roller Coaster readers filing MedWatch complaints. They simply didn’t work the same as Concerta does.
Things changed in 2017 when the Trump-appointed FDA chief over-ruled FDA scientists concerns about regular Concerta generics’ bioequivalence.
Next thing we know: A leaky boatload of junk generics. (Yes, some work better than Concerta for some people. That’s not the point. The point is that they are not bioequivalent, and that’s the basis for generic status.)
9. 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.
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:
Jennifer Taubert, Executive Vice President
Worldwide Chairman, Pharmaceuticals, Janssen Pharmaceuticals
Vanessa Broadhurst. Company Group Chairman
Global Commercial Strategy OrganizationJanssen Pharmaceuticals
10. My Comprehensive Post on Concerta Generics
You’ll find my main post on Concerta Generics here: Authorized-Generic Concerta Update
The first version of this post appeared 12/1/22.