What’s Up With Generic Concerta?

You can read updated details about generic Concerta in this 12/12/13 post; please subscribe to this blog to stay apprised of developments.

After advising caution regarding generic medications for ADHD here and here, I’m now hearing that Concerta is recently available in a 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? Maybe. In fact, it might be the exact same medication.

Original Concerta, 54 mg

The details are hard to come by in a field swimming with lingo: co-licensed product, single-source generic, authorized generic, bioequivalent and clinically equivalent. My conversations with pharmacists and the manufacturer’s scientific liaison leave me thirsting for straight talk with no tricky qualifiers. Internet searches and first-person reports in online forums are made murky by the apparently marked difference between Canada’s generic Concerta and that in the U.S.. (Forum participants seldom specify where they live, presumably because most don’t realize there is a difference between the two countries’ generic versions of Concerta.)

The U.S. generic for Concerta is  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 the so-called “authorized generic” are manufactured in the same plant, said the Ortho-McNeil spokesperson by phone. And, this authorized generic is both bioequivalent and clinically equivalent.  Does that mean it’s the exact same medication?  Yes, according to this FTC report on generic drugs, it is the same product:

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.

According to a press release 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.

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 a generic drug.  That means the generic version is exactly like 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 if the results are the same.

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Comments

  1. says

    Thank you for posting/

    I thought I was given the wrong med. that is how I found your post. I thought I would do some research before going back to the pharmacy. The generic I was prescribed is exactly what is posted Lbir: Kremers Urban / Methylpenidate ER 54 MG Tab.

    I picked up my refill and today was the first time I took it. There is no point in taking this generic medicine it does not work. I will contact my doctor to see if there is an alternative.

    I will print out your website for him to check out, and to see others are having the same issues.

  2. nancy says

    My daughter also noticed that the generic was not as effective as the brand name. I use the generic, but have a few of the brand name still left, for when I need to really concentrate. This past refill I asked the doctor to do a Brand Name Only Rx.

  3. Mark T says

    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.

    • says

      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

    • Mark T says

      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?

    • says

      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

    • Mark T says

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

      Regards,
      Mark.

  4. Jeff Kreines says

    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.

    • Barbara says

      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

  5. Tiffany says

    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!

  6. Donna says

    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.

    • says

      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. Helen says

    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.

    • says

      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

  8. Terri says

    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.

Trackbacks

  1. […] Backstory: Watson struck a deal with Concerta’s manufacturer, Janssen: Watson would delay introducing their own generic to compete with Concerta if Janssen would manufacture and supply Watson with this brand-name Concerta, allowing it to market 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.) […]

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