Authorized Generic Concerta Medication Update

 

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

Quick Summary Points:

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

  • It’s a rapidly changing story. What was true yesterday might not be true tomorrow.
  • I keep it organized best I can, 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!)
  • 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”.
  • 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, that might be your best bet. See link in story below.
  • It might be that one of these generics suits you better than Concerta. That isn’t the issue.
  • The issue is that 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:

  1. Your best options now — overview
  2. Specifying 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!)
  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

First: Please Support This Reader Service

    • For seven+ years, I’ve taken the lead in first 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 time and effort.
    • 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” who has rejected pharma funding. 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 – @Gina-Pera-1 . You can also shop via my Amazon link to right—and support this blog cost-free to you! Thank you!

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 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.). And that can be a huge difference.

2. Specifying Authorized-Generic Concerta

This is the information you can share 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, better, 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. The “no substitutions” box. This is tricky. See more details below.
  7. 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.”

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.

To be crystal clear, the prescription should 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.”

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

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

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 share 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, as a result, 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. 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’ concerns about bioequivalence. That is, do these generics work as well as the brand versions?

This is especially critical when it comes to medications with 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. Instead, they were simply ignored.

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 enormous and 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!)

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

Consumers are still able to procure 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.

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 methylphenidate medications
  6. Always look before you pay! If the pill does not say Alza, it’s not Concerta (brand or authorized-generic)

Again: What’s An Authorized (or Branded) 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 (aka branded 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, I see no hope of reversing this horrible decision by FDA Chief Gottlieb. He left after about 17 months, back to the rightwing think tank, the American Enterprise Institute.  But it would take a cataclysmic event to reverse this decision.

Still, it’s worth putting it on record. As I mentioned, the FDA in 2017 was incredibly responsive to our complaints about the first two Concerta generics. But that was before the new administration took the White House.

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.

Summary

For sure, this is a lot to take in!  (Guess what! it was a lot to research and attempt to write, too—and constantly re-write—not to mention field 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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1,030 thoughts on “Authorized Generic Concerta Medication Update”

  1. Interestingly, we seem to have had kind of the opposite problem – my daughter first got prescribed concerta meds in 2020 and was put on a round white (I think) pill that worked Perfectly for her. She didn’t need all day every day, just something to give her a little boost to get her through the school day. Now that pill is apparently no longer AB rated so we can’t get it through the military pharmacy we use, and I naively never wrote down what the exact prescription was, so I’m having trouble seeing if it is still available any other way. Without telling us they simply refilled her meds last time with the 24 hour barrel pills by avkare and they have been Terrible. She can’t get enough sleep and has a stammer now where she repeats words over and over, and when we don’t give them on the weekend she is 3x more adhd than normal. But, she also can’t function in middle school without some sort of adhd med. We are reaching out to her Dr to talk about options since apparently she didn’t know about the switch either (a different dr on the team processed our refill last time), but I don’t know what we are going to do until we get something figured out. Hopefully her teachers will be understanding.

    1. That circular pill might be the Amneal brand. It worked really well for us too, even though it’s not AB rated anymore. I called Amneal and they are manufacturing it again but have not released it to distributors yet – maybe mid-October they said. We switched to Camber and it’s been okay. We also had a terrible experience when the generic brand switched. The government really needs to tighten generic manufacturing regulations and monitoring.

    2. Hi AB,

      A little history, as you can read about in the post: “The government” was absolutely helpful when I first started looking into this, in 2014 or so. A FDA representative suggested that I open a MedWatch complaint about the first three inferior generics. I did, readers followed through in reporting their adverse experience, and those inferior generics were downgraded by the FDA.

      Then Trump and the Republicans took over, appointing an FDA with more ties to industry than to science or regulatory bodies. He pushed through dozens of generics — many of them over the objections of FDA scientists. And that is why we are dealing with this now.

      “Government” is us, and who we vote for. :-). Not a “political” post. Just the facts.

      g

    3. Hi Caitlin,

      Can’t your pharmacy find that order and the manufacturer? It should be on record, somewhere.

      I would press your doc and pharmacy to remedy this ASAP, not to wait. The sleep deprivation alone is a huge problem, and one that might linger if she ever gets better Rx.

      It might be that even Ritalin LA would be better than what you have. And that would probably be easy to get.

      But going forward, if you cannot find the generic you prefer, maybe try the brand/authorized-generic.

      Good luck
      Gina

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