A Recap: Consumer’s Guide to Generic Concerta

 

Some of this information is now outdated (though much is not). Please also see my latest comprehensive post on how you can get the authorized-generic Concerta now:  Consumer Q&A on Concerta Generics.

Why the concern about the new generics for Concerta?  I’ll tell you.

It can take much trial and error to find the ADHD medication and dosage that works best for an individual. Once it’s found, you don’t want to monkey with it!  (Especially when you don’t even know you’re monkeying with it!)

So, when long-time Concerta users felt that it had stopped working or was working less effectively, they were understandably alarmed.

  • Some worried that they had “habituated” to the medication. With certain exceptions, however, that is not typical for the stimulant medications.
  • Others worried that another variable was interfering—extra stress, a flu or cold, a different teacher at school, etc.
  • Fortunately for some, they found the ADHD Roller Coaster blog and traced that change to their prescription being filled with one of the new generics.

Do you find it shocking that a pharmacy could change a patient’s medication so drastically with no warning?  I do. What’s worse, when some readers went back to their pharmacy,  pharmacists patted them on the head and assured them that generics are the same as brand. Not so!

It is true that generic medications generally work as well as brand. That does not mean, however, that they are the exact same as brand. Here is an excerpt from a previous post on the topic (share it freely with any doubting pharmacists):

Moreover, as any experienced physician can tell you, generics can wreak havoc with that narrow “therapeutic window” — the dose that works best with the least side effects.

  • A few milligrams up or down can mean trouble, and the FDA allows a wide window of efficacy.  
  • In the U.S., the FDA  requires the bioequivalence of the generic product to be between 80% and 125% of that of the original product. That’s a bay window, for petesake!
  • Bioequivalence does not mean that generic drugs must be exactly the same (“pharmaceutical equivalent”) as their original product counterparts. Significant chemical differences may exist, especially when it comes to extended-release medications.

Concerta’s True Generics Vs. Authorized Generics

There’s one big reason, though, why  many people get confused about the Concerta generics: There are at least three generics within two distinct categories of generics. To understand the distinctions, we have to understand how the FDA defines each type of generic.

I’ll try to make this as simple as possible. Stay with me!

In sum:

  • The first (the”authorized generic”) isn’t a generic at all, in the common sense of the word. Rather, it is the brand marketed as a generic.
  • The second (“true generic”) is a generic in the common sense of the word. Within these “true generics” of Concerta are several manufacturers’ offerings.

1. The One Authorized Concerta Generic: Watson/Actavis

There is only one authorized Concerta generic; the supplier is Watson/Actavis (old name/new name).  Remember: An authorized generic is the brand drug marketed as a generic. The only difference is in price and name. Period.

Backstory: Watson (the company later changed its name to Actavis) struck a deal with Concerta’s manufacturer, Janssen: Watson would delay introducing their own generic to compete with Concerta. In exchange, Janssen would manufacture and supply Watson with this brand-name Concerta. That would allow Watson to market Concerta at a cheaper-than-brand price and give Janssen a piece of the profits.  This deal should last through 2014. (I wrote about this in detail here.)

Name on the Rx: methylphenidate hydrochloride extended-release tablets

Appearance: exactly the same as Concerta. A capsule imprinted with “alza” (the makers of Concert’s unique delivery-technology called OROS) and featuring a laser-drilled hole. (See photos below; color will vary with dosage strength)

Bottom line: If your generic Concerta is imprinted with “alza,” you have the brand medication. Period. Also, if you have one on hand, look for the little hole at the end; that tells you this capsule contains OROS, the laser-drilled osmotic pump that is the Concerta delivery-system technology.  The word “alza” is followed by the miligram of that pill.

Alza 18 Concerta OROS

Alza 36 Concerta OROSAlza 54 Concerta OROS

The Two “True Generics”: Mallinckrodt and Kremers-Urban

These two offerings are generic in the traditional sense of the word. That is, a medication that is very similar to the brand and ostensibly works as well but is not the exact same as the brand.

Currently in the U.S., there are two “true generics” for Concerta. (Note: Another is available in Canada, Teva-Methylphenidate ER-C; Toronto-based Dr. Kenny Handelman discusses this generic on his blog.)

These generics are as follows:

1. Mallinckrodt

Mallinckrodt began with only the 27 mg but now also markets its 36 mg and 54 mg generic Concerta.

[Update: Even though the FDA has downgraded this generic as inferior—meaning, you should not have to accept it if nyour insurance requires you to take a generic—Mallinckrodt is fighting it. Pharmacies such as CVS are still routinely filling prescriptions with it.]

Name on the Rx: methylphenidate hydrochloride extended-release tablets

Bottom line: This generic does not use brand-name Concerta’s OROS delivery system; you’ll see no laser-drilled hole on the end of these capsules, pictured below. Remember: It is the OROS delivery system that distinguishes Concerta.

Mallinckrodt’s generic of Concerta depicts an “M” in a square, followed by the milligrams; it does not use the OROS technology and instead appears to be more similar to Ritalin LA, a far less sophisticated delivery system. The color varies by dosage; here is the photo of the 27 mg.

2. Kudco (Kremers-Urban)

Name on the Rx: methylphenidate hydrochloride extended-release tablets

Bottom line: As with the Mallinckrodt offering, this generic does not use brand-name Concerta’s OROS delivery system; you’ll see no laser-drilled hole on the end of these capsules, pictured below. Remember: It is the OROS delivery system that distinguishes Concerta.

Update: Kudco has complied with the FDA ruling downgrading this generic and withdrawn the product.

The box looks like this (the color varies by dosage strength):

And the pills look like this, in the 18 and 27 milligram dosages:

Dissatisfied with Your “True” Generic?

Here Are Your Options:

It is possible that, for some people, the generics might be preferable to the brand; the slight differences in action might work to your benefit.

If you have tried the “true generics” and found them unsatisfactory—or you’re not willing to gamble with the change—here are your options:

  1. ALWAYS check your pills before you pay for them. You typically cannot return them once you pay for them and especially after you leave the store.
  2. Ask your pharmacy to carry the Watson/Actavis/OROS authorized generic (same as brand)
  3. If the pharmacy refuses, call other pharmacies in your town.
  4. If your health insurance includes a mail-order option (typically, 60- or 90-day supply), ask if that pharmacy carries the OROS. If not, ask how much more the brand Concerta will be.   (Note: I find the mail-order option much easier; why go through the hassle 12 times annually if you can cut it to four or six? I detailed how it works in this post, Tip: Home Delivery of Stimulant Medications.)
  5. Ask your physician to indicate “no substitutions” on the Rx script if the OROS generic is unavailable and you are willing to pay for the brand.
  6. Ask your physician to write a note to your health insurance company saying that you or your child experienced intolerable side effects to the generic and you must have brand. (Be prepared to pay the brand price, though.)
  7. Ask your physician to write “OROS only” on the prescription; Watson is in the process of changing names to Actavis, so it’s likely that confusion will result if either name is used instead of OROS (the technology that makes Concerta unique).
  8. Complain to your health insurance carrier.

FINALLY: Please report any adverse side effects from “true generics”

Above all, if you or your child experienced adverse reactions to the Mallinckrodt or Kudco/Kremers-Urban generics of Concerta (and have not had such reactions to the brand/”authorized generic” Concerta), please do yourself and everyone else a favor:  File a complaint here with the FDA’s MedWatch (scroll down to the box that says “consumer”).

If the FDA receives sufficient data that a medication merits investigating, it will do so. A generic of Wellbutrin XL was recently recalled after such an effort (explained in this previous post).

I hope this answers some questions and settles the confusion!

Please subscribe to this blog to be notified of updates on this continuing saga.

For more background, see this post (“What’s Up with Generic Concerta?”)

Gina Pera, author and Adult ADHD expert

For more information on Adult ADHD and its treatment strategies, including how to get best results from your medication, please consult my book‘s three chapters on the topic.

33 thoughts on “A Recap: Consumer’s Guide to Generic Concerta”

  1. I just came across this because until this past month, after almost 20 years, my pharmacy filled my generic Concerta with round tablets I have never seen nor taken. They don’t work at all. This was at CVS. After finding out the information about the equivalency not being the same it made sense. This month has been the worst I’ve had. I took the information to the pharmacy and they said the Oros/Actavis was discontinued and this is the substitute.

    I’m LIVID to say the least!

    1. Hi Steve,

      I’m livid, too!! They are jeopardizing real, life humans lives—relationships, occupations, DRIVING for petesake.

      It’s one thing, if CVS doesn’t want to carry the OROS/Actavis. But to tell a customer that it’s been discontinued…..WOW.

      CVS has been particularly egregious during this two years of mess. I’ve constantly heard stories where the downgraded generics were substituted for OROS– which is illegal!

      If you can, look for another pharmacy. I’ve heard the Walgreen’s has been more reliable.

      I manage my husband’s prescriptions, because I’m just better at it. But I get the refills only four times a year, given our 90-day home-delivery pharmacy benefit.

      Here is the blog post I wrote on the topic:

      https://adhdrollercoaster.org/tools-and-strategies/stimulant-prescriptions-via-mail-order-pharmacy-maybe/

      I’m glad you found my blog post.

      best,
      g

  2. Here we go again, it starts all over. Now every pharmacist in my city is no longer carrying the Actavis version of Concerta. They have all switched to the Mylan version. As far as we can tell this pill do not have the OROS delivery system.

    Has anyone tried this new version of generic Concerta?

    1. Hi Jeff,

      The Actavis version (Concerta, sold as an authorized generic) will be the only Concerta generic utilizing the OROS technology.

      It’s still available as a generic, so I’d hunt for that.

      g

    2. CVS has switched from the cylinder Concerta to the round ones. Just on my last refill which was 11/3. I called a different pharmacy and they said they had the right ones in stock. I never have had this issue and I’ve been taking Concerta for years. The round ones suck and CVS said they no longer made the Actavis ones yet HEB pharmacy said they had them in stock.

      I’ve been a CVS customer for many years. No longer. F cvs!,

    3. Hi again Steve,

      So you found another pharmacy (HEB) that can help you. Stick with them!

      I agree. It’s heinous behavior for CVS. I publicly scolded them on Twitter. I’m sure it hurt their feelings. 😉

      I miss our old Long’s drugstore, which was purchased by CVS. Nothing is as good there, imho.

      Glad you found a more helpful pharmacy.

      g

    4. I have tried the Mylan 36mg and its actually pretty good. No side effects at all. I’ve also tried the branded Janssen in comparison. Mylan from my experience is a good brand.

      I then got given a generic called Sandoz from a new pharmacy i went to which was awful! I suffered for a whole month. It did not work at all and only enhanced my ADHD symptoms and i was irritable all the time. Very unhappy period. It comes as a round pill which is unusual for ADHD medication. Never again.

  3. Hi,
    I know this is an old post, but I need help and you seem quite knowledgeable on the topic! My daughter was prescribed Concerta in the spring of 2016 at 9 years old, it worked wonders and I wished I hadn’t waited so long to medicate! Now when I refilled her prescription two weeks ago I realized when I got home it had a different appearance and started researching before I gave it to her.

    The first one she was on the worked amazingly was Kremers Urban! Now she is taking the actavis and it is not working as well at all, even her teacher noticed a difference in her ability to grasp new concepts.

    My question is, is there another medication that works very similar to Kremers methylphenidate er? I am so nervous about starting her on something new, but actavis with OROS is not working and I read that a few days ago the FDA made a recommendation to ban Kremers Methylphenidate. Any suggestions or tips on closest medication to Kremers?

    1. Hi Heather,

      There is nothing “wrong” with these generics, such as the Kremers-Urban. The problem was that they were not adequately similar to Concerta to be considered the generic of that medication.

      So, if your daughter did better on the KU generic, you can still purchase it (for now). Talk to your physician and pharmacy about how you can get it.

      Good luck
      g

    2. Gina,
      Thanks, I did find a pharmacy that still filled KU as generic for Concerta (tsk tsk I know, but she needed it), I am wondering if KU becomes unavailable what we should try next that is very close to KU.

    3. Hi Heather,

      If it’s cheap, I’d try stocking up with a 90-day supply if you have a mail-order pharmacy that carries it.

      I doubt that it’s going to be taken off the market.

      It’s hard to know what would be close to it in profile. Essentially, these inferior Concerta generics are more like Ritalin LA than Concerta. So, I suppose it’s possible that if you end up not being able to get the KU, then you could try Ritalin LA.

      g

  4. Seems like enough harm for a class action lawsuit. Imagine a child’s initial exposure to Kudco ER methylphenidate versus an Actavis version. That case scenario would be parent and child reporting and experiencing an utter failure when in fact there was help actually in the OROS version.
    If Kudco knows this (the pharmacies also), as well as Kudco’s failure to comply with the FDA’s request for bioequivalence study: …” From Princeton, NJ – Nov. 14, 2014– Kremers Urban Pharmaceuticals Inc. (KU) has been informed by the U.S. Food and Drug Administration (FDA) that the agency requests an additional bioequivalence study based on recently issued draft guidance to confirm the therapeutic equivalence of the company’s methylphenidate hydrochloride
    extended-release (ER) tablets (CII) to the category reference drug.”… then lets set a precedent.

    1. I’m no attorney, but I would agree with you, Mark.

      The bigger “800-pound gorilla” is Mallinckrodt, which is defying FDA rulings. Shockingly brazen, if you ask me.

      I’ll have a follow-up post soon. The six month period given to the two companies (Mallinckrodt and KU) ended this week. KU has withdrawn. M not so, and pharmacies (especially CVS, it seems) are still substituting it for brand.

      I’ve posted several notices on Twitter, but don’t know if anyone’s paying attention.

      best,
      g

  5. My son was given the Mallinkrodt brand and has had headaches and stomach aches. It’s horrible when compared to the Watson brand Methyphenidate. This really concerns me that the pharmacy wanted to argue this with me at first thank God for your blog I am getting it switched back but it has been a pain to do this. Watson brand seems to be good!

  6. As of 11-13-2014, the FDA has now concurred with concerns about two of the three generic Concertas. See link below.

    http://www.fda.gov/Drugs/DrugSafety/ucm422568.htm

    “The FDA has changed the therapeutic equivalence (TE) rating for the Mallinckrodt and Kudco products from AB to BX. This means the Mallinckrodt and Kudco products are still approved and can be prescribed, but are no longer recommended as automatically substitutable at the pharmacy (or by a pharmacist) for Concerta.”

    Unfortunately, pharmacies are now refusing to dispense any generic Concerta, including Watson/Activis OROS tablets, based on the false assumption that all generics are affected by the FDA ruling. Also, unfortunately, most doctors are not yet aware of this.

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