Authorized-Generic Concerta Medication Update

Concerta and its generics: what you need to know 2022

Having trouble receiving the authorized generic Concerta medication for ADHD — again?  Well, you’re in the right place.

This post is constantly evolving. I update it as best I can.

TWO MAJOR UPDATES – 12/5/22

1. Janssen has stopped the authorized generic.

The official cut-off date is 1/13/23. But the last supplies have been already distributed, according to a Janssen representative. You might still find pockets of availability. At least for a while.

See my post for suggestions in the meantime — and to leave a comment for Janssen executives: Janssen Quietly Ends Concerta Authorized-Generic

2. I am re-leading the effort to downgrade these generics – FDA Medwatch

These generics are nothing like Concerta. That makes a world of difference for untold numbers of people currently relying on Concerta to function. They were FDA-approved over the objections of FDA scientists, due to concerns about bioequivalence.

These generics (that I describe in this post, originating in 2017) come to us courtesy if Big Generic and Trump’s FDA Chief. Robert Gottlieb, MD, was and is a venture capitalist who happens to have a medical degree.  I cannot think of another FDA chief who was as ethically compromised. Previous to his short FDA stint (2017-2019), he had long harangued against FDA regulations for complex delivery-system medications (e.g. Concerta’s). Shortly before Trump slotted him at the FDA, he was at the American Enterprise Institute and on the board of a vaping company. (Vaping Venture Poses Potential Conflict for Trump’s FDA Nominee).

That was 2017. It’s now 2022. With high hopes that decent people can again help right these wrongs,. I am re-launching the effort to downgrade these indecent generics.

Please go to this link (FDA Medwatch) to state any adverse experience with any of the Concerta generics (you’ll find the list of companies below). If you’ve thrown away the bottle, try to get the info from your pharmacy. (It probably won’t be helpful to provide a lot number, though. This is not a manufacturing problem. This is a exploitative Big Generic problem, which is unfortunately consistent lot to lot.

The rest of this post might be useful to you, insofar as understanding the difference between Concerta, its authorized-generic (going away 1/13/23, and its other generics.   But please know that the recommended method of getting the authorized-generic (brand sold at a generic price) is no longer relevant. For now. Things could change after January 1. Stay tuned!

Please Support This Reader Service

    • Since 2014, I’ve taken the lead in first successfully lobbying the FDA to downgrade the first two inferior generics and, since 2017, guiding readers on procuring the authorized generic. Others might “borrow” my work. But I put in the legwork.
    • For 20 years, I’ve accepted no pharmaceutical funding or support of any type.  That includes from the makers/sellers of Concerta!
    • That makes me one of the very few ADHD “names” rejecting pharma support. Specifically, the quid pro quo kind that the major pharmaceutical funder of ADHD “advocacy” requires. It’s called a conflict of interest.
    • You might be shocked at the covert ways in which this is playing out with that one particular pharma.
    • I minimize advertising — because it’s too distracting!
    • If my self-funded work has saved you thousands of dollars and much consternation, please consider a donation of any amount via Paypal — or Venmo. You can also shop via my Amazon link to right—and support this blog cost-free to you! Thank you!

Quick Summary Points on Concerta Generics:

As the first and only person to cover — and advocate on — this issue in-depth since 2014, I can tell you:

  • I aim for simplicity. But if I cut details—sure enough, comments will ask for them!  So, I happily risk Google docking this post for “too long.” (It favors short and superficial!) And I try to keep it well-organized and scannable.
  • This slew of cheap generics (in price and content) has sent pharmacies and insurance companies scrambling—only intensified by COVID demands..
  • Concerta pills use a patented delivery system (Alza’s OROS). It’s what makes Concerta distinct from the other methylphenidate-class choices.
  • The authorized-generic is the brand; it’s only marketed as a generic. The other Concerta generics are mostly “bare bones”—little different than a generic Ritalin.
  • If you’re confused about generic versus authorized-generic, you’ll find the details below.
  • Much depends on your particular insurance pharmacy benefit. Even within the same insurance provider (e.g. Blue Shield) different policies bring different benefits.
  • Don’t count on the average prescriber understanding this issue. But do offer a link to this blog post—or print relevant info and provide.
  • If you have a home-delivery pharmacy with one of the big warehouse pharmacies (e.g. Express Scripts), that might be your best bet. Seriously. See Home Delivery of Stimulant Medications
  • It might be that one of these generics suits you better than Concerta. That isn’t the issue.
  • What is the issue? These generics do not perform as brand Concerta does. That’s a big problem for people who respond best to Concerta’s sophisticated delivery system (OROS).
  • If you participate in an ADHD-related forum or another type of group,  please share the link to this blog post.  I’m seeing  sites repeat tidbits from this original reporting. But it’s out of context and without updates—and therefore unhelpful and also violating copyright.

In This Post:

Again, we are in a rapidly changing situation now in December 2022. We’re waiting for the year-end supply issues to resolve AND waiting to see what Janssen will do regarding making brand Concerta available in 2023. Stay tuned!

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  1. Your best options now — overview
  2. How to specify the authorized-generic for Concerta on the prescription – step by step
  3. Consider home-delivery pharmacy, if you have that benefit (yes, it’s legal for stimulants!) — please know there’s a difference between a local pharmacy that delivers to your home and a “home-delivery pharmacy” (e.g. Express Scripts, PrimeMail, etc.) These large warehouses typically are more likely to have the authorized generic and allow 60- or 90-day supplies. So much easier!
  4. Consider brand; there’s a Concerta coupon now
  5. Background: How this clown car of Concerta generics burst onto the scene
  6. Whatever happened to the “Actavis” generic?
  7. Now — Concerta generics from at least ten companies!
  8. Still confused about generic vs authorized generic?
  9. Consider filing an FDA Medwatch Complaint. This is not the FDA’s fault. Please don’t blame “government.” This was a cynical, profitable move by the previous administration’s FDA Chief—a huge gift to “Big Generic”

1. Your Best Options Now — Detailed

Here’s an overview of the best current strategies. You’ll find more details about how the script should read in the next section.

—Aim for Authorized Generic (from Patriot Pharmaceuticals)

This involves getting your prescriber’s cooperation, detailed below (Specifying Authorized Generic Concerta).

Tips:

  • Do not ask the store if it carries the authorized generic. Keeping a medication in stock and ordering it are two very different things.
  • If the pharmacy says it cannot fill your prescription, ask that an Exception Process be ordered for you. (This is working less reliably now than it did initially but it’s worth a shot.)
  • Still trouble?  Call Janssen 1-800-631-5273. Ask for its subsidiary, Patriot. 
    • The representative can sometimes intercede with a pharmacy. 
    • The list of pharmacies said to be carrying the Patriot generic might or might not be helpful.
    • Just because a pharmacy carried it one point doesn’t mean it is now. Moreover, it doesn’t mean that your particular insurance coverage will qualify you for it.

—Patriot Pharmaceuticals: Authorized Generics ONLY

Just in case Patriot website visitors also don’t understand the term authorized generic, it says this:

Patriot Pharmaceutical Generics are authorized for sale to trade customers by the NDA holder of the innovator product. [Note: NDA stands for New Drug Application.  It the vehicle through which a company proposes that the FDA approve a new pharmaceutical for sale and marketing in the U.S.. Not a new generic of an existing brand, a new pharmaceutical altogether.]

The entire Patriot family of products is made by the same manufacturers that are approved in the NDAs of the innovator products.

The same qualities you relied on in the innovator pharmaceutical products during their branded lifecycle are now available in Patriot’s authorized generic line of products. [A branded life cycle means “before the patent expires”.]

—Check out the new Concerta Savings Card

If you can swing the brand Concerta, that makes things much easier!  Check the savings-terms at the link.  It works with your insurance.  Note: Does not apply in MA or CA.

—Try another stimulant option

There are many choices within the methylphenidate category, including Ritalin, Daytrana, Aptensio XR, Metadate CD, Methylin, Quillivant XR, Jornay PM, Adhansia XR, Cotempla, etc..

One of these might work better for you than Concerta. Or they all might be worse. For the most part, you just don’t know until you try.

To be clear: These all contain the same active ingredient, methylphenidate (MPH). The only difference is in how it’s delivered to the system (how much, how quickly, etc.). But that can be a huge difference.

2. Specifying Authorized-Generic Concerta

Share this information with your prescriber for your next prescription. It should help to specify the authorized-generic Concerta on your next prescription.  Here’s the short version, followed by the details:

  1. Name: Methylphenidate HCl Extended-release tablets
  2. NDC Number:  for example: 10147-0685-1
  3. Specify distributor: Patriot only
  4. How it might read overall (example): Methylphenidate HCl Extended-release tablets, 36 mg, NDC 10147-0686-1 ONLY (or, simply Patriot generic only)
  5. A special note for electronic subscriptions:  Sometimes the prescriber will specify all this in the electronic prescription—but it’s not visible to the pharmacy.  Ask the pharmacy to look for the special instructions box or to print the prescription; that typically reveals full instructions.
  6. Always provide the information specifically to your prescriber. Each time. Some prescribers tell me they cannot see what they wrote for a previous prescription when they go to write the next one.  Make their job easier—and ensure your success in getting the right Rx.
  7. The “no substitutions” box. This is tricky. See more details below.
  8. Check the pills before you pay for them!

How long will this information remain useful?  It’s anybody’s guess. Subscribe to stay tuned — and check back often.

Here’s more details on the 5 steps above. I accessed this information from the U.S. National Library of Medicine “Daily Med” website.

—Name:

Methylphenidate HCl Extended-release tablets

NOTE!  You cannot rely solely on the name. All the Concerta generics (including the authorized generic) share this name!

—NDC Number:

Each FDA-approved medication is assigned a code, the NDC (National Drug Code). Here are the numbers for Concerta’s authorized generic (the last two numbers vary by dosage):

  • 10147-0685-1 – 18 mg
  • 10147-0688-1  – 27 mg
  • 10147-0686-1  – 36 mg
  • 10147-0687-1  – 54 mg

My advice is: Ask your prescriber to specify the NDC number and “Patriot generic only.”  At least the first time. It might be unnecessary after that.

Note: If your pharmacy says that number is not coming up in their database, they might instead find the 11-digit billing code.

For example, the 36 mg replaces one hyphen with a zero.  That is, NDC 10147-0686-1 has a billing code of NDC 10147068601. For the full details, click here: NDC 10147-0686-1 METHYLPHENIDATE HYDROCHLORIDE.

—Distributor: Patriot

What if the pharmacy tells you, “But we can’t find that”? or “It’s on back order”?

Maybe the store or chain simply doesn’t want to order it for you.

To check, call the Patriot Pharmaceuticals customer service at 215-325-7676 

—How Should The Prescription Read Exactly?

No ironclad answers here. Your prescriber might have a preference.  The pharmacy might, too. Tip: Try to get a straight answer from the pharmacy before speaking with your physician.

In the best of all possible worlds, the script need only contain the name of the drug!  But again, in the case of Concerta generics,  they are ALL called Methylphenidate Hydrochloride (HCI) Extended-release tablets. That makes it critical to establish which one.

As the issue first emerged, the prescription should have read something like this (for example, for the 36 mg dose):

Methylphenidate HCl Extended-release tablets, 36 mg, NDC 10147-0686-1 ONLY (or Patriot generic only)

The “ONLY” at the end indicates, “do not substitute with another generic.”

Now that the Patriot generic is more familiar to pharmacists, adding the NDC might be overkill.

Note: Some readers report that their pill bottles exclude the HCl (which stands for hydrochloride). If the pills say “alza,” don’t worry about it.

—Tricky Bit #1: Generic substitution laws vary by state.  

Your prescriber must pay attention to the prescription pad checkbox that indicates “no substitutions” or “dispense as written”.

If that is checked, pharmacists typically take that to mean, “Do not substitute a generic.”  That means you might get brand—at brand prices.

But what happens when the prescriber checks that box AND specifies a generic but uses the name of the brand (Concerta) instead of Methylphenidate HCI, etc. ? Anything can happen!  That’s why you might follow my suggestion above. But again, ask your pharmacist first!

If you use a home-delivery pharmacy, consider attaching a note to the paper order form detailing clearly your request.

See Tip: Home Delivery of Prescribed Stimulant Medications

—Tricky  Bit #2: Some generics utilize a different type of osmotic technology.

But that is not the same as Alza’s patented OROS (osmotic-controlled release oral delivery system).  Many pharmacists do not know this! You might need to tell them! (But don’t count on them believing you.)

—Look Before You Pay!

What Should The Pills Look Like? Look for alza 18, 27, 36, 54 etc 

Look before you pay!

The pills should look exactly the same as the brand—because they are the brand.  It’s easy. Look for the word alza on the pill.  Not there? Then it’s not Concerta brand or authorized generic. Simple as that!

—Must the Pharmacy Fill the Prescription As Written?

It depends on your state laws.  Again, check this  article in U.S. PharmacistGeneric-Substitution Laws

—What Should The Label Look Like?

Before you leave the pharmacy or open a home-delivery bottle, look for the label.  It should say  Patriot Pharmaceuticals.

Do not pay for the prescription until you check the label and the pills themselves.  The Concerta brand/authorized-generic should look like the pills in the photo above. You can typically see this through the semi-translucent brown bottles.

3. Investigate Home-Delivery of Concerta

Does your insurance pharmacy benefit include a home-delivery pharmacy? If so, consider using it!

Again, home-delivery pharmacies typically have bigger inventory. Plus, you might be able to get a 60- or 90-day supply. Imagine enduring this misery only 6 or 4 times annually—instead of 12 times!

Yes, this is legal!   Read more here:  Tip: Home Delivery of Prescribed Stimulant Medications

4. Consider Brand Concerta Or Coverage Exception

Don’t forget to look into brand. Janssen is making brand Concerta more accessible in some ways, including a savings card.

Have you already tried one of the inferior generics, to poor effect?  You might ask your pharmacy-benefits-manager about pre-authorization or “medical coverage exception.”  This is where your prescriber documents your previous experience and why you need the brand.

5. Background: Why This Clown Car of Concerta Generics?

When the first three Concerta genetics arrived, I started hearing from readers. Lives were going off the rails — too many to attribute to personal issues. Something larger was going on.  I shared some of their stories here: Sound Off – Users of Downgraded Concerta Generics

What does “downgraded Concerta generics” mean? It means that I spoke with the FDA and, following the helpful representative’s suggestion, opened a formal MedWatch Complaint.  Then, readers followed through on reporting their adverse experiences on these generics.   The FDA came through for us in 2014:  Victory! Concerta Generics Downgraded

Unfortunately, the new administration that moved into the White House had other plans.  Donald Trump named a a new FDA chief, Scott Gottlieb, MD. He was and is now, having left the FDA a short time later, a fellow at the conservative American Enterprise Institute. He over-rode FDA scientists’ longheld concerns about bioequivalence. That is, do these generics work as well as the brand versions?

This is especially critical when it comes to  novel delivery systems, such as Concerta’s OROS, patented technology from Alza. That’s why the FDA downgraded the original three generics. FDA scientists were pushing for new guidelines.

Next thing we know: A clown car of non-bioequivalent Concerta generics flooded the market.  Pharmacies and insurance companies have been log-rolling in response this enormously unexpected change. But one thing’s for certain: This been a huge gift to “Big Generic.” (Check the end of this post for links to my various posts on that topic.)

Reader comments sometimes blame the “government” or the FDA for this. That’s a mistake.  We can lay this outrageous situation squarely at the feet of one administration.  (Don’t like me “bringing politics into it”?  Sorry, these are the facts, and facts still matter.)

This turnabout came as a stunning disappointment to Concerta users. We thought that hard-won war was over.

Fortunately for consumers, Janssen continues to make available the authorized-generic Concerta. But the landscape continues to shift.

6. Previously: Concerta Brand and Actavis Generic

Many years ago,  Concerta users became accustomed to receiving the authorized generic. That is the brand marketed as a generic, at generic pricing. It was marketed by a company called Actavis.

How did this come about? Concerta manufacturer Janssen made this deal to forestall Actavis introducing its own Concerta generic. That marketing agreement expired several years ago. A generic manufacturer named Teva later purchased Actavis. Then it released its own Concerta generic.

Shortly after, Concerta manufacturer Janssen made the authorized generic available through a subsidiary, Patriot Pharmaceuticals. For more than a year, largely thanks to my guidance, Concerta users were able to ask their pharmacy to order the Patriot authorized generic via an “exception process” (explained below).

A few drugstores reliably honored the request, even if it meant losing money. Walgreen’s was a particularly good “corporate citizen.”  But obviously, Walgreen’s could not continue taking such a financial hit, compounded by COVID.  If you’ve been getting the authorized-generic from an independent pharmacy, it’s might have lost money providing it.

For the most part, these generics resemble generics of Ritalin or Ritalin LA. These brand drugs already lack Concerta’s sophisticated delivery system. So you can imagine how little they resemble Concerta.  They perhaps cost pennies to make, in China or India. In factories increasingly shown to be poorly regulated.

By contrast, brand Concerta uses a proprietary technology, OROS™, from a company called Alza.  FDA guidelines on producing brand drugs are highly controlled. The medication (methylphenidate) is released at a steadily ascending rate. With the generics, it tends to be uneven, in jumps, starts, and stalls—with a fast drop-off.

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7. Still Confused by Generic vs. Authorized Generic?

If you remain confused about generic vs. authorized generic and the historical changes, you might find the following information useful.

  1. If you’re still asking for Actavis/Teva, you risk an unpleasant surprise.
  2. The authorized generic is the brand; it’s simply sold as a generic. See how to request it above.
  3. The authorized generic (brand marketed and sold at generic prices) is now distributed by Patriot Pharmaceuticals, a subsidiary of Janssen, Concerta’s manufacturer.
  4. Look for  the infographic below.
  5. Consider getting the brand until the dust settles, if it’s affordable (remember the new savings program at Concerta’s website). Or, try one of the other brand methylphenidate medications
  6. Always look before you pay! If the pill does not say alza, it’s not Concerta (brand or authorized-generic).  Simple!

Again: What’s An Authorized Generic?

I understand the confusion.  Even many pharmacists and physicians can’t tell you the difference. Even worse, many also insist that regular generic medications are “exactly the same” as brand. They are not. Consumer beware.

I’ve covered it before (again, the roundup of blog posts)  but here are the basics:

1. Authorized generic:

The authorized generic is the brand. It’s only marketed and sold as a generic.

This typically happens when a brand drug patent nears expiration. Another company strikes a deal with the brand manufacturer: “We’ll delay introducing our regular generic if you agree to let us sell your brand as a generic.”

As mentioned above, that’s what happened with Concerta several years ago.  The manufacturer, Jannsen, agreed to let a company named Watson sell its brand Concerta as an authorized generic. As time went on, Watson became Actavis and Teva purchased Actavis. In the past, the prescriber could specify on the prescription: “authorized generic Concerta/Watson, etc.”—or simply OROS.

OROS™ is Concerta’s patented extended-release technology. It is owned by a company called Alza and licensed by Janssen in making Concerta. (The osmotic-controlled release oral delivery system, OROS, takes the form of a rigid tablet with a semi-permeable outer membrane and one or more small laser-drilled holes in it.)

Since then, for a variety of reasons, it’s gotten more challenging.  Pharmacies are consolidating and are less “consumer-oriented.”  Some of the new generics use other osmotic technology. As a result, some pharmacists mistake “osmotic technology” for the proprietary OROS™ from Alza.

2. True generic:

This is what most of us regard as a generic medication.  It’s a cheaper alternative to a brand medication.  It is made by a different company, not the brand’s manufacturer.

Even though it is often claimed to be “exactly the same” as the brand, it is not. In some cases, this matters little. When it comes to sophisticated delivery-system drugs, it can matter a lot.

Unfortunately, pharmacy insurance benefits increasingly force consumers to accept these generics or pay a very high cost for the brand.

For more details, read Consumer Q&A on Concerta Generics

Gina Pera authorized generic Concerta how-to

8. Now Concerta Generics From At Least Ten Companies

Over the last two years, the situation has grown even more confusing. At least seven companies released Concerta generics since July 2017 [Note: there are even more now, in 2021]:

  1. Manufacturer: ACTAVIS LABS FL
    Approval date: March 21, 2018
    Strength(s): 54MG [AB]
  2. Manufacturer: ACTAVIS LABS FL
    Approval date: March 22, 2018
    Strength(s): 18MG [AB], 27MG [AB], 36MG [AB]
    NOTE: Actavis used to be the distributor for the authorized generic Concerta; now it has its own generic.
  3. Manufacturer: ALVOGEN PINE BROOK
    Approval date: November 30, 2018
    Strength(s): 18MG [AB], 27MG [AB], 36MG [AB], 54MG [AB]
  4. Manufacturer: AMNEAL PHARMS
    Approval date: February 1, 2018
    Strength(s): 18MG [AB], 27MG [AB], 36MG [AB], 54MG [AB]
  5. Manufacturer: ANDOR PHARMS
    Approval date: April 24, 2019
    Strength(s): 18MG [AB], 27MG [AB], 36MG [AB], 54MG [AB]
  6. Manufacturer: ANI PHARMS INC
    Approval date: July 14, 2017
    Strength(s): 18MG [AB], 27MG [AB], 36MG [AB], 54MG [AB]
  7. Manufacturer: MYLAN
    Approval date: October 21, 2016
    Strength(s): 18MG [AB], 27MG [AB], 36MG [AB], 54MG [AB]
  8. Manufacturer: OSMOTICA
    Approval date: July 28, 2017
    Strength(s): 18MG [AB], 27MG [AB], 36MG [AB], 54MG [AB]
  9. Manufacturer: PAR PHARM
    Approval date: July 15, 2019
    Strength(s): 36MG [AB], 54MG [AB]
  10. Manufacturer: ASCENT PHARMS INC
    Approval date: September 3, 2019
    Strength(s): 18MG [AB], 27MG [AB], 36MG [AB], 54MG [AB ]
    NOTE: The Ascent generic (distributed by Camber) uses a barrel-shaped pill. It seems designed to fool consumers/physicians/pharmacists that this generic uses OROS. It does not.

9. Consider Filing an FDA MedWatch Complaint

To be frank, it’s going to be much harder to reverse this horrible decision by the Trump White House’s FDA Chief Gottlieb. He left after about 17 months, back to the rightwing think tank, the American Enterprise Institute.  It would take a cataclysmic event to reverse this decision. And they all knew it.

Still, it’s worth putting it on record. As I mentioned, the FDA in 2014 was incredibly responsive to our complaints about the first two Concerta generics. Then a new White House occupant moved in.

If you have tried one of these true generics and found it significantly inferior to brand/authorized-generic Concerta, please consider filing a MedWatch complaint with the FDA. You can download a PDF or file directly online. Click here to go directly to the FDA Medwatch form.

Summary—Whew!

For sure, this is a lot to take in!  (Guess what! It was a lot for me to research and write, too—and constantly re-write—not to mention field 100s of reader questions.)

I hope these quick points clarify things for you. If not, leave a question in the comments section.  Readers who have followed my suggestions precisely seem to have a higher success rate.

Many argue that without that delivery system, it cannot be a reasonable substitute for brand Concerta. FDA scientists agreed with them. That’s how my blog readers played a critical role in lobbying the FDA to reassess the first two Concerta generics. The FDA downgraded them as not being close enough to Concerta.  Then another White House forced a change.

Here is my report on that issue: Consumer Q&A on Generic Concerta

The first version of this post appeared 6/19/19 but my reporting on Concerta generics began in 2014!

I answer all questions as quickly as possible.

Gina Pera 

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  1. Simply  begin your Amazon shopping expeditions in the box to the right. Just bookmark it as “Amazon” and a small portion of your purchases will help to defray my costs. Thank you!
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1,133 thoughts on “Authorized-Generic Concerta Medication Update”

  1. In your section 8, you note that the Ascent / Camber generic does not use the osmotic delivery system. But the package insert from Camber (https://www.camberpharma.com/wp-content/uploads/2020/08/4130-31341-Pack-Insert-for-Methylphenidate-Hydrochloride-ER-Tablets-USP-Ascent-Camber-955-08-2021a.pdf) says it does. How do you know that it doesn’t?
    From Camber: “Methylphenidate hydrochloride extended-release tablets uses osmotic pressure to deliver
    methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in
    appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane
    with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing….”

    1. Hi Robert,

      I know this is all SO confusing. I do my best to educate on all the details, so it makes sense. But it’s a lot to wade through.

      Please read again. I did not say, as you wrote, that “the Ascent/Camber generic does not use the osmotic delivery system.”

      This is what I wrote: NOTE: The Ascent generic (distributed by Camber) uses a barrel-shaped pill. It seems designed to fool consumers/physicians/pharmacists that this generic uses OROS. It does not.

      The general term is osmotic delivery system. There are many types.

      OROS is the patented, trademarked osmotic delivery system used in Concerta. The only methylphenidate product to do so. It’s patented by a company called Alza (later purchased by Janssen parent company J&J). That’s why Concerta pills say “alza”.

      Again, this doesn’t mean Camber’s generic is “bad”. It means it doesn’t use Concerta’s delivery system and so, by scientists who understand these things, it’s truly not “bioequivalent” to Concerta. Meaning, can be interchanged without any noticeable difference.

      I hope this helps
      Gina

  2. Due to the adderall shortage I was forced to find an alternative medication for my adhd. My doctor switched me over to methylphenidate XR. The pills appeared reddish-brown with a capital M surrounded by a square and the number 54 next to it. Curious about the manufacturer I did some googling and “Mallinckrodt” popped up. Any updates on this particular generic since 2016? Is this the same generic trash as 7 years ago?? Do you know of any reliable tactics of exchanging stimulant medication for a different formulation if already filled. I know this is unlikely, but hoping there might be a way.

    1. Hi Shelly,

      I wonder why your doctor didn’t at least try to keep you in the amphetamine class, if that’s what you’d settled on as best for you. Mydayis is essentially Adderall in an extended-release formulation. There are savings programs, last I checked.

      As to your question….yes, that’s Mallinckrodt. I can’t imagine it’s any different. That’s one of the two generics downgraded by the FDA as not bio-equivalent.

      All that’s different, really, is the Trump’s FDA chief, who reversed the decision and pushed through these generics.

      I don’t think you can exchange stimulants. Never heard of it, anyway. Once you pick it up at the pharmacy and open it, it’s yours.

      That typically doesn’t that you have to gut it out until your 30 days (or whatever) are up, not if it doesn’t work for you. Much depends on your prescriber and your insurance plan, though.

      good luck
      Gina

  3. Thank you Gina

    I have good news and bad news from my family’s latest adventures.

    1. The good news is that Patriot authorized-generic Concerta doesn’t seem to have been available at such a wide variety of pharmacy chains in years as it is right now. If you’re about to fill, call around and ask about the NDCs Gina’s listed — you might be surprised how easy it is for you to find. Call pharmacy chains who’ve told you before that they’d stopped ordering Patriot because it was so expensive. Lots of them are ordering it this week.

    2. The bad news is that places that had stopped carrying it seem to have all ordered it because they can’t get their hands on any other generic Concerta nor on the brand-name Concerta. So if you’re NOT about to fill, the remaining supplies of Patriot Authorized Generic Concerta are about to FLY off the shelves of almost every pharmacy serving almost every single Concerta patient everywhere, because it’s the ONLY Concerta of ANY sort in stock at many places.

    1. Wow, that is very strange. Thanks for the report from the front line.

      This will no doubt vary by geography, type of pharmacy, and pharmacy chains/warehouses.

      But seems it’s worth a try.

    2. Name brand is available just fine. My pharmacy has been ordering it for me every month and shows up in a few days from date of order. Literally just filled it Tuesday. No problems at all.

    3. Good for you, Jackie. Unfortunately, not everyone is as fortunate.

      There’s endless variability store to store, chain to chain, insurance pharmacy benefit, etc.

      g

    4. To add to Jackie’s comment, I find that when I call around and ask about “methylphenidate ER” I often get slammed first off with “ sorry on back order, no idea when we get some”. Only if I pursue and ask if they have brand Concerta do they say “ oh yeah but insurance won’t cover it “ ! This even when I’m calling a random pharmacist who has no idea about my coverage! Often they actually do have it, the other days call actually confirmed they had some *right there on the shelf*! So weird! And to reports of Patriot being available places as of a week ago I had not gotten that sense at all in my flyover-country lands, but just filled anyway so I guess out of luck in any case . I’m getting tired of the idea of being jerked around for my kid so we’re starting the search for acceptable alternatives. But I do want to keep up with any “ class actions “ — indeed why don’t we do one of those ?!?! I mean seriously ….
      Anyway, good luck and cheers to everyone!

    5. Hi M,

      There’s been a big shift from Concerta brand being covered fairly widely (definitely not comprehensively, though) to being covered rarely. Maybe that’s what the pharmacists mean.

      What would be the basis for a Class Action suit? I don’t think there is any.

      Trump’s FDA chief pushed through these Concerta generics in 2017….making them “legal”….after some of us worked very hard to have the first two downgraded — and succeeded. But that was 2014.

      Mega-mergers also happened during the Trump administration that likely would not have been allowed before and after. When I saw that two 800-pound gorillas — CVS and Aetna — were merging, I knew no good would come of it. It came as no surprise when CVS rarely (if ever) filled prescriptions with the Concerta authorized-generic. Walgreen’s did. Sometimes other pharmacies. Not CVS. Wasn’t as profitable as the junk generics, I figure.

      Elections have consequences. When we don’t know what’s happening (or what HAS happened), we tend to blame all wrong parties.

      Good luck in your search. There are many other options out there.

      g

  4. Hi Gina !
    Any thoughts or comments on “Relexxii” as an alternative to Concerta ? It seems to have been “approved” in June 2022, and it is shown to be in the same mg doses as Concerta but it is not a Concerta generic? Seems to be connected to all these different LLCs owned by the same acquisition fund Avista, Vertical Pharma and Osmotica both? Looks like a weird series of money moves and that is what it is of course, but the recent “ approval “ of something that looks like a Concerta generic but as a new brand feels like we are about to see another work-around on coming off-patent for a medication that has a distinct mechanism of action? I don’t see it even as available yet on GoodRx for instance in anything but the 72 mg dosage? I’m so confused! Thanks for any help you can offer here! Cheers…

    1. Hi M,

      “Weird series of money moves” is right! 🙂

      One doctor friend tells me that the 72 mg Relexxii is bioequivalent to the Concerta 72 mg. Maybe that’s why it’s the only one you see?

      Why not the other doses? I have no idea. Stay tuned.

      And yes, Relexxii is a brand, not a generic. The generics have generic names (in this case, methylphenidate ER; they’re known mainly by their manufacturer’s name.)

      Mainly, I am letting folks know there are many other methylphenidate options, some of them brands with no generic (e.g. Quillivant).

      good luck!
      g

    2. Thanks for that info Gina and the wishes for luck—we’ll need it !
      So strange . If it’s the same as Concerta then why is it allowed to get new drug RLD status ?! My insurance formulary doesn’t even list it which isn’t surprising because it was just approved in June 22.
      The FDA orange book shows all the same mg dosages as Concerta, and a branded approval for all done in June 22.

      https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=216117#

      The 72mg version has been marketed by Vertical Pharmaceuticals as a cool way to —get this — cover two non ER 36 mg doses! Did they get special RLD brand approval for that? It seems to have been sold as 72mg but without a brand name ? I can’t really tell here because they are claiming it is the “ first and only er 72 mg” ?
      https://www.methylphenidateer72.com/

      So now Vertical Pharmaceuticals and Osmotica have both been bought by Avista and so I wonder if Vertical actually did have a “real” OROS type action that they “gave” to Osmotica to use to get Relexxii approved as a new RLD?
      This seems like a giant work around to the idea that medications go off-patent at some point so consumers can benefit from lower costs.
      It’s like somehow someone creates decent action OROS tech outside of ALZA and gets the FDA to approve its use in essentially re-producing Concerta and claiming it is a novel agent?! Could this have been a long term play in getting all those garbage generics approved in the first place?! Oh see the generics for *Concerta* don’t work so here we are creating the “next generation” Concerta!

    3. Good questions, M.

      I’ve been puzzling this with an ADHD specialist MD, and we’re still scratching our heads.

      Waiting for more info….all we can do, I guess.

      g

    4. Hi again, ugh, NOW I realize that *Trigen* merged with Vertical before being taken over by Osmotica ( dizzying this M&A stuff and frightening when done with companies whose products have such profound effects on peoples lives !) so I am not hopeful about this “Relexxii” product because iirc people did not find the Trigen generic action similar to the Alza in the Concerta! Unless Osmotica has come up with something better than they used to have, the “new agent”approval for Relexxii in dosages that look just like Concerta looks like a “replacement” for the whole product and the combo of that with the rumors that Jannsen is moving away from the adhd market and the fact that they are closing the Alza plant they run in Vacaville
      https://www.fiercepharma.com/manufacturing/janssen-laying-off-four-dozen-employees-as-california-plant-slated-for-closure

      A sale to another company of the same Alza tech would be one thing, but my fear is that they have decided none of this matters to the patients, and maybe they’ll just force us to transition to a whole different product. That nobody will pick up the same tech because J&J owns Alza. Trigen/Osmotica/Vertical (now I realize the three of them were bought/ organized under a “Alora” llc for a while recently or maybe still? How that relates to Avista partners who knows; lord each of these transactions means money changing hands that doubtless is more behind the outrageous prices we pay for pharma than money they actually spend in R & D ) maybe knew Jannsen was wanting to “ leave the space “ and got RLD approval for their inferior tech and that’s what we will be left with? I have to say I’m not hopeful about someone else putting out a decent generic for Concerta and I wouldn’t doubt that with all this PE money parked into the scene that Alza tech will not be licensed to anyone for adhd products, certainly not anything affordable. I can imagine a number of behind-the-scenes “ agreements” among the players here to make it all stock price / profit margin “win-win” for the corps and not good for us people .
      I do realize that we’ve been weirdly lucky with the authorized generic for years , but it feels like this moving *any* osmotic tech to a new RLD and leaving the slew of non OS generics for us if brand is not covered for us is what is in the works . Which gee if generics had been pulled for not being therapeutically equivalent and now they approve a new RLD that is the same thing as Concerta just with an inferior OROS ?! This would be fascinating to watch play out if it weren’t so horrific for patients .
      Good luck to us all!

    5. Wow, good sleuthing on the Alza plant. I mean, bad news, but good data.

      Big Generic pays absolutely zippo on R&D. They just slide in on the path Big Pharma has paved, exploiting loopholes all the way and fattening pockets.

      When I was first trying to figure out what was going on…back in 2013 or so…I called a pharma patent attorney. He explained that the first two generic cos – Mallinckrodt and Kremers-Urban — were “brilliant in exploiting FDA loopholes….GENIUS!”

      I’m fairly jaded in this regard but even I was shocked….repulsed. All I could mutter out was, “Genius….if you’re a SOCIOPATH.” Good grief. These people are absolutely detached from any concern about consequences for others. It’s only their greed and dominance that drives them.

      Specifically to your point: “It feels like moving any osmotic tech to a new RLD and leaving the slew of non OS generics for us is brand is not covered for us is what is in the works.”

      That is exactly the problem. And it’s what we fought in 2014, only to have Trump’s FDA Chief break it all over again.

      Consumers CAN file an FDA Medwatch complaint. That’s how we did it before. In revisiting this with the FDA two weeks ago, I was assured they are paying attention to the complaints. We need to get on it. Easier said than done when people are scrambling for Rx that keeps them functional, much less able to take on anything else.

      good luck
      g

    6. I wish I didn’t feel the need to keep digging but it’s my kid I’m trying to help and I am a digger by nature ( PhD in psych, not clinical though! Probably should have done something more archives based —my own untreated adhd keeps me hyper focused on searching for answers sometimes !)
      As I am trying to research other Concerta like meds, I looked into Adhansia XR and I see there had never been a generic version approved it seems and the manufacturer—Adlon Therapeutics, a subsidiary of Purdue —has discontinued it as of July 22 🙁

      https://adlontherapeutics.com/products/

      They say this was purely “a business decision” and not anything about effectiveness or safety . Thanks pharma!
      Looks like they may have declared bankruptcy maybe part of paying for Purdue sins in other domains?
      So, hmm, maybe shortages of everything are also being driven by these products sitting around after being “pulled “? It’s so unpleasant the lack of concern for the patients!
      So now on to checking on Aptensio for us, to try, given that the action is maybe easier-to-reproduce-in-a-generic extended release capsule? I’m trying to find ones that have claimed duration similar to Concerta and we are working with a primary care physician who is great but not a specialist in these things.
      Probably after we do a trial of a Concerta generic to most likely file a medwatch because we’ve had a non-authorized generic before but it was years ago and was able to get the authorized again.

    7. I suspect this stunt with FDA Chief Gottlieb created havoc all around — and not just with ADHD medications.

      It’s massive.

      But yes, at least two new ADHD Rx came from Purdue, as I recall, and Adhansia is one of them.

      It’s great that you can do preliminary research like this, but unsolicited advice…it’s easy to get lost in the weeds, trying to read the “tea leaves” regarding mechanism of action, etc… When really what needs to happen is trial and error, unfortunately.

      You probably know this, but one way to start separating wheat from chaff is to think about the profile your child best needs — that is, more oompph in the morning, a steadily ascending rate, etc..

      good luck,
      g

    8. Thanks again Gina! Even for the unsolicited advice 😉 !
      Any advice on where to look online for clues on course-of-day profiles? Adhansia was appealing on paper because it’s duration on a well known adhd website that gives length of action seemed to be among the longer ones and it’s long duration that seems most needed for my kid ( who is essentially young adult now but Only done meds for the last bunch of years) . It wouldn’t be terrible for quicker morning kick-in but beyond that the only complaint I’ve heard is crash at like 8 to 10pm, which really, what more can you hope for lol? They started with a pediatric rec of Concerta and it was good right off so haven’t ever had to do trial and error yet but yes I do appreciate that this is what will ultimately determine what will be best!

      Anyway thanks again for all you do!
      Cheers!

    9. You know, there’s always the option of a second dose, even if the prescriber has never heard of such a thing.

      My niece asked her doctor for a second dose, for her 12-year-old, who was crashing in the afternoon, and the doctor said, “You can’t do that because of the DEA!”

      Wrong-oh. But typical.

      You can always look up the product label for each brand. But when it comes to getting its generic, it could little to no resemblance.

      BTW, my course on optimizing ADHD-related sleep and medication.

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

      g

  5. Hi KSK,

    Yes I hope you have continued luck getting Concerta and paying a lower cost. We are in Massachusetts and we cannot make use of the coupon. I was debating paying for brand, but since it is not in my insurance’s formulary, I think that even if we reached deductible they wouldn’t cover anything. We’ll see where this takes us. I’m kind of curious now to have my daughter try another methylphenidate brand. I like what I read about Jornay PM. Thanks for sharing. And yes, thanks to Gina. I’ve been following her blog for years. To be honest I wish we didn’t need to become such experts on this. If only patients needs came first.

  6. Suzanne Stock

    My insurance is only covering Quillivant because there’s not another liquid extended release available at the moment and it’s just been 2 months. I don’t know how long it’s going to last.

    Most of my researching starts right here with you, Gina. Thank you.

  7. My daughter’s been on Concerta Authorized Generic since about 2010. So whenever it switched to Patriot was when we would have noticed we no longer received the ALZA pill. Lord knows I can’t remember the year but we know it was under Trump. However I don’t know if the bum generic we received was TEVA or something else. It was whatever CVS gave us. Makes me wonder then if I answered his question correctly as, yes, at one point she would have received the Activis/TEVA Authorized Generic which was fine, until it wasn’t. But for most of the time after that we were able to get the Patriot Authorized Generic (ALZA). Try to explain all that to some stranger on the phone who I could barely understand for his accent. In any case I know insurance will try to screw us because that’s what they do. If not, then pigs fly and hell has frozen over and drug companies care about people.

    1. Hi Kathy,

      Patriot is a Janssen subsidiary. When the previous deal expired (with Watson-Actavis-Teva), the AG was distributed by Patriot.

      Teva then went forward with its own Concerta generic. A “true” generic, not an authorized-generic (brand sold as a generic).

      The DEA tightly controls stimulant Rx. I bet you could ask your pharmacist to check your history and see what you got in 2017.

      good luck,
      g

    2. Hi Kathy,
      I will say that Gina has been a Godsend with all of this! And even that doesn’t cover how much I have respected and followed her research and sound advice. We ultimately had our doctor (this is for my son) go through the prior authorization route. He stated that the generics caused great sensitivity with adverse reactions to my son that prohibited him from taking them. The prior authorization was approved for the brand name Concerta for 1 year. However, the cost was still a bit high. My son takes both 36mg + 54mg per day. So a 90 day supply for each strength, was $180. ($180 x 2 = $360 per 90 days / 3 = $120 per month) We then went to the Concerta website and downloaded their savings card. The Concerta Savings card brought each strength down to $30 for a 90 day supply!!!! Meaning, $20 per month for both strengths. Now…… I have no idea how long this will last. Especially with the Concerta savings card, and I suppose I should read the fine print now so I’m not left scrambling when this ends. But for now, this will do. And, believe it or not, this was through our local CVS too. (I’m still scratching my head over that one as we’ve never had much luck with them.) But yes, it is possible. $20 per month for the brand Concerta through CVS. Fingers crossed that we’ll be able to maintain this status for the next year. Good luck to you and anyone else who reads this – GINA is amazing!!!!

    3. HI KSK,

      Thanks for the update! I’m so pleased my tips have worked for you and your child.

      I, too, am surprised it was the local CVS. Must be a particularly nice branch manager! Or even CVS is getting an avalanche of requests.

      Did you get the 90-day supply at the local pharmacy? Not a home-delivery? That’s unusual! Though I imagine it depends on the state and the policy terms.

      Happy for you!

      g

    4. Hi Gina –
      Yes, 90-day supply through our local CVS! Again, I have no idea how long this will last, so I’m going to keep my fingers crossed. This has been such a roller coaster!!!

      Thank you again for all of your advocacy, suggestions, ideas, and research. You really are a very special persona and I appreciate everything you have done for the ADD community!!!

    5. Victory to the people! 🙂

      Yay! I’m happy for you.

      The public has no idea….taking ADHD rx is an “easy fix.” HA!

      You’re most welcome. I’m happy that my work has helped you. It’s why I do what I do!

      take care,
      g

  8. I returned the call to TEVA. All of his questions regarded TEVA’s generic and honestly I don’t know if my daughter ever tried TEVA. She may have. All I know is when the other generics became available we got whatever CVS gave us. I’m assuming TEVA is what Optum Rx prefers? At other times through my local independent pharmacy she tried Camber and I think Trigen. Anyway he asked me about adverse health effects and I said her mood, attention, concentration, sleep, appetite. He asked me when she last tried TEVA. I guessed and said 2017. All I know is that when the mess started I did everything to find the Authorized Generic and I was successful. Now I wait. I get the feeling they will say she should try TEVA again since it has been 5 years. Okay fine. She is willing to try. But if no good we’ll go back to the exception process or try another methylphenidate. Wouldn’t it be wonderful if Concerta Brand came down in price? I don’t know why they don’t. They’d get a lot more sales.

    1. Kathy – I’m pretty sure the TEVA formulation hasn’t changed since 2017. That would have required an entirely new approval process.

      And I agree that it’s a mystery….why Concerta brand doesn’t come down in price. Janssen is losing unimaginable numbers of customers.

      Perhaps Janssen has already sold it.

      g

    2. Although, wasn’t TEVA/Actavis the provider of the Authorized Generic right before it switched over to Patriot? Kathy might’ve lucked out and actually received the AG in 2017. Trying to remember when it went to Patriot, maybe early 2019? Not sure.

    3. Hi Ann,

      Yes, the Janssen/Watson-Actavis-Teva agreement expired at the end of 2017.

      So. yes, good point, Kathy might have received the AG.

      I try to emphasize using ALZA to identify the pill, not the distributor’s name. Makes things easier—and more accurate! 🙂

      g

    4. Suzanne Stock

      Kathy,
      In looking for other methylphenidate products for myself, I searched for the extended release profiles or pharmacokinetics and found the graph for Quillivant is similar to Concerta. My insurance is paying for it and so far it works for me.
      Good luck.

    5. Teva core is a hydrogel matrix. Concerta is a tri-layer core. The hydrogel matrix is not osmotic release. We tried my son Teva and it was not a good fit. It did little to control his symptoms. Everything in my area is back ordered … we plan on trying Camber and/ XLcare generic whenever it is available. Their profile seems similar to Concerta… tri-layer core and osmotic release. Anyway hoping these generics are a better fit for him.

  9. I have talked with my daughter’s doctor about requesting Concerta Brand with our insurance through their exception process. We have Tufts HMO with Optum Rx for pharmacy (used to be CVS Caremark). I had a message on my answering machine today from TEVA Pharmaceuticals regarding Methylphenidate. I will call tomorrow but it seems strange I’m getting a call from TEVA. What do they have to do with my insurance or Concerta? Is our insurance trying to push the TEVA generic on us? I’ll update tomorrow when I call them back. I’m feeling AAAAARRRRRGGGGGHHHHH!!!!!!!!!

    Kathy

    1. VERY INTERESTING, Kathy!

      This isn’t the first such incident. I have a feeling that Teva is overstepping its bounds—and pharmacies are encouraging it.

      If it was CVS, well, anything goes with them. (Optum Rx and CVS have partnered.). I avoid them.

      Absolutely, Teva’s generic is being pushed on you, and I bet you’ll hear that it’s “just like” Concerta. It isn’t.

      Conflict of interest, it seems.

      g

      g

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