What’s Up With Generic Concerta?

Here at the ADHD Roller Coaster, I’ve long cautioned about generic medications for ADHD. Articles include Update on Generic Rx: Approach with Caution and Consumer Reports on Autos? Yes. ADHD Medications? No!

I’m now hearing that Concerta is recently available in a new generic form in the United States. (A generic has been available in Canada for some time, but it is a different type of generic.)

The question: Does this generic perform as reliably as Concerta? The answer: Yes. We know this because this particular Concerta generic is the brand; it is only marketed as a generic. That makes it an authorized-generic — not a standard generic.

You can read updated details about generic Concerta in this post- last updated 6/01/2022: Authorized Generic Concerta Update; please subscribe to this blog to stay apprised of developments.

Original Concerta, 54 mg

Searching for Clarity

The pharmaceutical industry swims with lingo: co-licensed product, single-source generic, authorized generic, bioequivalent and clinically equivalent, and so forth.

As I sought clarity on this issue, I spoke with pharmacists and the Concerta manufacturer’s scientific liaison. It all left me thirsting for straight talk with no tricky qualifiers.

Even more confusing: Reading first-person reports in online forums. For example, there is a marked difference between Canada’s generic Concerta and that in the U.S..  Yet, forum participants seldom specify where they live. Presumably, that’s because most don’t realize there is a difference between the two countries’ generic versions of Concerta.

An Authorized Generic IS the Brand

For this post, I’m addressing only the U.S. generic for Concerta.

It’s not a” true” generic—that is, a medication that is produced to be a reasonable facsimile of a brand. It is an “authorized” generic. In other words, this is the brand marketed as a generic.

On the label,  you’ll see methylphenidate hydrochloride extended-release tablets.  It is a co-licensed product by exclusive agreement — that is, a deal between the original manufacturer (Ortho-McNeil) and the pharmaceutical marketing arm of Watson Laboratories.

Both brand-name Concerta and this authorized generic are manufactured in the same plant, said a spokesperson for manufacturer Ortho-McNeil  by phone. And, this authorized generic is both bioequivalent and clinically equivalent.

Does that mean it’s the exact same medication?  Yes, according to an FTC report on generic drugs, it is the same product (FTC Report Examines How Authorized Generics Affect the Pharmaceutical Market.

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Excerpt:

An authorized generic is a lower-cost, generic-label version of a brand-name drug that is already sold by the same manufacturer.

The Hatch-Waxman Act is designed to ease the introduction of generic drugs by, in certain circumstances, granting a 180-day period of marketing exclusivity to the first generic competitor of a brand-name drug, known as a “first-filer.”

During that exclusivity period, no other generic company can receive FDA-approval to sell its product. However, this marketing exclusivity period does not prevent brand-name companies from introducing their own authorized generic versions.

When Patents Expire, Deals Are Sometimes Struck

According to a press release (no longer available online) from Watson Laboratories, the first patent for Concerta is set to expire in 2018. Thanks to a legal settlement between two pharmaceutical manufacturers, however, a generic version became available much earlier, in May 2011.

Due to the settlement, Watson Laboratories is allowed to sell an “authorized generic” version of Concerta through 2014. [Update 2019: Generic company Teva is now distributing the authorized Concerta generic, but the company and Concerta manufacturer Janssen have made public no deals about their agreement.]

Here is the apparent bottom line:  The original manufacturer, Ortho-McNeil. supplies Watson with brand-name Concerta tablets; Watson packages and sells the tablets as an authorized generic drug.

That means the generic version is exactly the brand-name Conceta in every way, except in price. For example, our mail-order pharmacy was charging $120 for a 90-day supply of Concerta; for this authorized-generic version, the charge is $20. Quite a savings!

[Update: Other “true” Concerta generics entered the scene later, and that’s when all the troubles started.]

258 thoughts on “What’s Up With Generic Concerta?”

  1. Hi there!! So after reading this very interesting article (which I am ever so grateful I have found you!!) I was able to have my prescription like your said to have it written by my doctor and it worked!! I got the patriot pharmaceuticals brand for $20 as my generic!!
    Even the pharmacist could not believe it that I got this brand he said that he thought this was the brand name Concerta and was shocked I even knew about this thanks to you my friend !

    Grateful patient of yours from CO

  2. Hi Gina,

    I’m from Portugal and here we only have one concerta’s generic, it’s form the lab SANDOZ.
    Have you ever read something about it? Or do you have some feedback on it?
    I really can’t find anything useful to decide if i should keep going with the original or switch to this Sandoz generic.

    Thanks!

    Ps: Your blog is really good, and helpful!

    1. Hello Ana,

      I’m happy to have a grateful reader in Portugal!

      I just did a little research on this Sandoz generic. It looks to be a generic, similar to our “problematic” generic.

      It does not have the OROS technology (the laser-drilled capsule that makes Concerta, Concerta).

      Here’s one study….interesting to note that the food in the gut seems to affect absorption.

      http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4317218/

      If you can, I’d stick with the brand. Of course, you could always try the generic, to see if it works well for you. And, if not, go back to the brand.

      Good luck!

      g

  3. Pingback: Consumer Q&A on Concerta and Generics

  4. Hi there,

    I work in a pharmacy and we were told by our corporate headquarters that all generic concerta medications could not be sold except for Watson brand because the FDA said that they are not equivalent to brand concerta. So if a Dr writes for a Concerta prescription that does not state brand only we can substitute with Watson because that is a recognized equivalent. Also just be aware what your insurance requires with the new guidelines. I have seen after 3 to 4 years after a generic is available that insurances will not cover a brand name medication even if it is medically necessary. So just be aware that insurances can change their mind on what they will approve at any time and do not have to give any notice to anyone. It is super frustrating for those working in the pharmacy to be the bad news givers.

  5. Is there any information on whether or not Watson will continue making their generic in the same form they have been making it after the legal agreement is no longer valid in 2014? We have just started my daughter on Concerta. We got the generic (Watson brand) the first month and switched to the brand name the second month. It was only after getting the brand name that I realized that the prior months prescription was exactly the same as the brand name. My concern is that if we switch back the to generic (Watson) that they will start to manufacture it differently (more like the other generics) and we’ll be back where we tarted with paying the full price for the brand name.

    1. Hi Helen,

      I’ve written about the various types of generics several times on my blog. I encourage you to use the “search” function and read all the posts about generics.

      In short, the Watson/Actavis Concerta IS the brand. It is simply marketed as a generic, price-wise. These are called “authorized generics” but it’s not a generic at all; it is the exact same Rx.

      Best,
      g

  6. I am having a hard time finding Concerta brand or the generic from watson. My son has issued with generic and all I can get is the pink. My question to the pharmacy was “if its pink does it have red dye 40 which a lot of children have issues with. I specifically request Watson and they told me it has not been available. I also had the dr go back to do not substitute and still received the generic (which I sent back) I had to go to a different state to find the brand because not one pharmacy had it. This is getting ridiculous.Does anyone know whats up?? With our plan I can only go to cvs or rite aid.

    1. Hi Donna,

      Sorry to hear you’re having so much trouble. My best advice is to avoid the local pharmacies, if at all possible. If your health insurance policy includes a mail order provision go with that. Other than that, Walgreen is the only store I’ve heard that regularly carries the Watson generic.

      tx
      g

  7. Hi all!

    It is definitely not the same as the Concerta with the OROS release. 6 years I have used Concerta. I was prescribed the new generic and had to go back as well. 1. It hits you hard all early in the day and makes you gittery and then you hit a wall and it is like a caffeine high falling off a cliff. I get to 3 or 4 pm and could pass out and nap anywhere. And I am not a napper.

    Ask your Dr. to make sure to not allow a subsititute and makw sure it is Alza with the dot on the side.

    Good luck!

  8. Jeff Kreines

    I was delighted to get the Mallinkrodt generic because I saved $80 on my co-pay. Then I tried it. I was not looking for problems, but noticed a day in that the drug was not working as the Alza version did. Now I am working to get my pharmacist to switch his generics to the Watson version.

    1. Thank to everyone who figured out there was a problem. January 2013 ish, after having never been on ADHD medication before (I am 46 yr Old female, just graduated college 2012 & now have a stumbling block in grad school), I was prescribed concerta and was given a generic, I’ve continued to have problems and concerns about my medication. Earlier in the year I received a letter from my insurance company they are re-evaluating if concerta will be a covered medication and would have a final answer in August. I called my Dr and he was going to switch me to Ritalin, I’ve been taking 2 36mg per day. I decided to wait to hear what my insurance company came back with before changing even though the cost for the prescription was very expensive. When it came time to refill, I called my insurance company and the cost was actually going to be significantly lower from before. The pharmacy said my insurance required only the name brand and does not permit or will not cover the generic.
      I’ve just started the name brand and will see how it goes. I had gotten to the point I’ve been raising such a fuss over asking if I am on the right medications after so many medical problems my dr. did a DNA test. He said that rather then guessing and messing around with anything now the test will show what medications metabolize best in my system.
      I’ve been relentless trying to figure out what’s been going on. Now finding out that it could have been because of a generic drug, I am hoping that things will get better in some way. I don’t think they could get any worse at this point.
      Barbara

  9. Pingback: ADHD Roller Coaster: "Is It You, Me, or Adult A.D.D.?" · We Did It! Concerta Generics on FDA Watch List

  10. Gina, I came across your site by accident while looking for Concerta price deals. I have recently been diagnosed with Adult ADHD and my insurance company has just refused to cover me because I’m over 25 years of age.
    I managed to get a 30 day trial and it changed my world. Now I’m left in a dilemma because my local pharmacy is asking $180 for 30 54 mg tablets. I just don’t have the extra cash to do this every month. I was interested to know were you got the 90 days supply for $120 and $20 for generic.
    Thanks in advance for your advise.

    1. HI Mark,

      Are you in the U.S.? That will make a difference as to insurance guidelines.

      The FDA has approved Concerta for adults, so the insurance company cannot use age to deny you.

      I would try to fight that restriction. Talk to customer support (for the insurance company) and explain your situation. Ask for your options or ways you can appeal this. There is almost always a way to appeal.

      It might be that the insurance company objects to the brand name, and wants you to take generic instead. Sometimes what happens is that you have to try the generic and report the adverse effects (if indeed they are adverse) and then you can get the brand.

      In other words, I wouldn’t take this lying down.

      But maybe I am misreading; you say “my insurance company has just refused to cover me because I’m over 25 years of age.” Do you mean you “aged out” of your parents’ policy?

      As for the 90 supply I wrote about, that is from my husband’s insurance coverage, with the Rx mail-order option.

      Gina

    2. Hello Gina, Yes, I am in the USA. I live in Massachusetts and in this case I am the parent with the policy. In fact, Im 50 years old and have gone un-diagnosed until I read a very good article on a recent American Airways flight which defined every symptom I have had all of my life. I was tested and came in high. On checking today, because the denial is as recent as yesterday, I have discovered that it is my company who are refusing to cover ADHD medication for Adults over 25 and my insurance is simply doing as my company says.
      Im not sure how they can do this if the Government have approved it? As we live in MA, Im also told that I can not have more than 30 days on one prescription. Is this true?
      If I decide to pay myself, what is the cheapest option for me?

    3. Hi Mark,

      I don’t know the applicable rules. It just doesn’t sound right that your employer can stipulate this restriction.

      My understanding is that the Affordable Care Act (Obamacare), among other reforms, prevents the insurance companies from discriminating against “mental” illness — as if the brain were not an organ and the most complex organ of all!

      I would think that, by state law, there should be some kind of information on that denial letter of how you can appeal this.

      Have you asked your prescribing physician?

      As for the 30-days prescription, yes, this is a standard limitation with prescriptions covered by insurance when filled at the local drugstore. But most policies offer a 90-day or 60-day supply by mail-order.

      As for cheaper options, you should check with the patience-assistance program for Concerta. Here is their customer service info:

      For more information, please call CONCERTA® toll-free.The CONCERTA® phone number is
      1-800-JANSSEN, and we are available from Monday through Friday, 9:00 am – 5:00 pm ET.

      Meanwhile, I would encourage you to read my book: http://www.amazon.com/dp/0981548709/tag=wwwginaperaco-20

      Sometimes the stimulant medications cause problems over time because most adults with ADHD have another condition, such as anxiety, depression, etc. Those conditions can be exacerbated by the stimulants. So, often there is a pairing of medications to treat both conditions (e.g. a stimulant and an antidepressant). My book covers in detail how to get better results from medication.

      Good luck!
      g

    4. Thank you Gina, I feel reassured after reading your good guidance. Next stop Amazon.

      Regards,
      Mark.

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