Victory! Concerta Generics Downgraded!

Concerta generics downgraded

The best news! The FDA announced today that the two approved generic versions of Concerta manufactured by Mallinckrodt Pharmaceuticals and Kudco have been downgraded.

It’s horrifying that so many people have already been adversely affected, and without warning—and their concerns dismissed by some pharmacists and even physicians.

“It’s the same as the brand,” some pharmacists said. “No, it’s not!” we said. And the FDA heard us.

ADHD Roller Coaster readers had much to do with that!  Many of you followed through by filing a complaint with the FDA’s MedWatch program, as I’ve encouraged repeatedly over the past year.

That form was NOT easy to complete, especially if your meds were underperforming! And I’m sure Dr. Kristen Stuppy, who blogs at Pediatric Partners, is celebrating. She has worked hard to publicize this issue, too.

Please note: A more recent post provides updates on this topic: Authorized-generic Concerta update  But you might want to first read the background info below.

Congrats and Hooray!

You can read the full press release below.  I’m pulling out this very practical point here for emphasis.

In short, 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.
  • If you take Concerta, it’s worth having a chat with your physician about this. Perhaps bring in a copy of this announcement, below or share the link to the post above: Authorized-generic Concerta update

Methylphenidate Hydrochloride Extended-Release Tablets (generic Concerta) made by Mallinckrodt and Kudco

[11-13-2014] FDA concerns about therapeutic equivalence with two generic versions of Concerta tablets (methylphenidate hydrochloride extended-release)

Based on an analysis of data, FDA has concerns about whether or not two approved generic versions of Concerta tablets (methylphenidate hydrochloride extended- release tablets), used to treat attention-deficit hyperactivity disorder in adults and children, are therapeutically equivalent to the brand-name drug. The two approved generic versions of Concerta are manufactured by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd.

FDA has not identified any serious safety concerns with these two generic products.  Patients should not make changes to their treatment except in consultation with their health care professional.

If you or your health care professional are concerned the drug product is not providing the desired effect and you do not know the manufacturer, contact the pharmacy where the prescription was filled to verify the product’s manufacturer.  If you, or those under your care, are taking the Mallinckrodt or Kudco products and have concerns about lack of desired effect during the dosing period, contact the prescribing health care provider to discuss whether or not a different drug product would be more appropriate.

FDA’s Scientific Evaluation of Generic Concerta Products

An analysis of adverse event reports, an internal FDA re-examination of previously submitted data, and FDA laboratory tests of products manufactured by Mallinckrodt and Kudco have raised concerns that the products may not produce the same therapeutic benefits for some patients as the brand-name product, Concerta, manufactured by Janssen Pharmaceuticals, Inc.  Janssen also manufactures an authorized Concerta generic, which is marketed by Actavis under a licensing agreement and is identical to Janssen’s Concerta.  FDA included the authorized generic in its analysis and found it to be bioequivalent to, and substitutable for, Concerta.  Apart from the Mallinckrodt, Kudco, and Actavis products, there are no other generics for Concerta.

Methylphenidate hydrochloride extended-release products approved as generics for Concerta are intended to release the drug in the body over a period of 10 to 12 hours. This should allow for a single-dose product that is consistent with the effect of a three times per day dose of immediate-release methylphenidate hydrochloride.

In some individuals, the Mallinckrodt and Kudco products may deliver drug in the body at a slower rate during the 7- to 12-hour range. The diminished release rate may result in patients not having the desired effect.

As a result, 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.

Consequently, FDA has revised its draft guidance for industry for bioequivalence testing for methylphenidate hydrochloride extended-release tablets (Concerta). FDA has asked that within six months, Mallinckrodt and Kudco confirm the bioequivalence of their products using the revised bioequivalence standards, or voluntarily withdraw their products from the market.

FDA will continue to evaluate its testing and approval standards and bioequivalence guidances for other generic methylphenidate hydrochloride extended-release products and revise as needed.



41 thoughts on “Victory! Concerta Generics Downgraded!”

  1. Pingback: Top 10 Posts: ADHD Roller Coaster 2015 - ADHD Roller Coaster with Gina Pera

  2. I am another person that can attest to how ineffective the Mallinckrodt generic Concerta ER (54 mg) is.
    And- I Just received the Mallinckrodt Generic Concerta in the mail again. (April 30, 2015)

    After a conversation with a pharmacist from my mail order company 3 months ago, I thought this brand would not be the substitute any more.
    Of course, I called the mail order pharmacy when this new batch of the Mallinckrodt came. This pharmacist said I need to have my doctor write that a generic can not be substituted.
    What’s going on? Do I have any recourse with the new 90 day supply?

    1. Good question, Cathy.

      I’m not familiar enough with the legalities, especially as they might vary by state.

      But that pharmacist is wrong, that you are asking for brand when in fact there is an authorized generic available.

      I would go up the chain of command, perhaps going to your health insurance company.

      And fax them, if necessary, this post (which is more current that the “Victory!” post on which you comment):

      My sense is that this pharmacist hasn’t a clue, the mail-order pharmacy has no supply of the “authorized generic,” and they are just feeding you a line of bull.

      If you get the runaround, I would take it to Twitter. I’ve found some of these companies are much more responsive when these problems are aired publicly. 😉

      Good luck, and please keep us posted.

  3. I’m not sure if this was a victory. My doctor knew log ago that everything but the Watson rx were crap. Now that the others are pulled from the market, our copay has doubled in 2 months.

    I resent Watson for capitalizing on a sad situation and am angry that the FDA doesn’t do something to prevent price gouging when a ruling of theirs doesn’t become a windfall for others.

    Anyone ever tried Quillavent? They have a $20 or 30 copay program and I’d like to avoid giving another dime to the maker of Concerta after their recent price fixing.

    1. Hi Jennifer,

      I appreciate your frustration. It is not in the FDA’s charter, though, to regulate pricing of medications, and that’s probably a good thing for consumers, especially when it comes to the introduction of new and better medication.

      As for the makers of Concerta, I’m sorry but you have it entirely wrong. Janssen has not been doing any “price fixing.” The company that is marketing the authorized generic of Concerta, Actavis/Watson, is competing in the marketplace. That’s how capitalism works. With all its problems, it’s still better than countries such as UK and, heaven forbid, France, where adults with ADHD are typically left high and dry.

      Instead of blaming the FDA, I would look to your insurance company. Ultimately, they have aided and abetted pharmacies whose profit margin is larger on generics than brand. Sometimes insurance companies even make money on generics, because the co-pay is more than the medication costs at places such as Costco and Wal-Mart.

      And yes, it definitely was a victory. Read the posts from people here, people who did not know the Concerta generics weren’t truly “equivalent.”


  4. Pingback: Sound Off: Generic Concerta Users' Stories - ADHD Roller Coaster

  5. Now the FDA needs to do the same with Actavis and their “generic Adderall XR” because insurance companies are being a royal pain about covering the authorized generics even though I know a pharmacist and in his database, some doses of the authorized generic is cheaper than the Actavis. I am an adult and I need to work etc. I think none of the kids are on Adderall XR these days or something because the moms went to town on the Concerta but the Actavis feels like taking nothing but a diet pill that gives me diarrhea and panic attacks.

    It didn’t even calm me down at all and they will only cover a specific quantity and I am on 60 mg and that is their “FDA approved amount” although the tablets, I can go up to 90 mg on those with no issues but I am used to the XR from global and it is the same one as before. Come on doctors, start putting the kids on Adderall again. It’s bad enough I am just “settling” with this drug because they don’t cover Dexedrine which is what I grew up on and worked the best for me.

    1. Hi Matt,

      I don’t know all the details on Actavis and its Adderall XR. But I did find this:

      Shire plc (LSE: SHP, NASDAQ: SHPG), announces that its subsidiary Shire US Inc. has entered into an agreement to supply an authorized generic version of its product Adderall XR. Under the agreement, Sandoz Inc. will market an authorized generic version of Adderall XR® beginning July 1, 2016. From the December 1, 2013 effective date of the agreement through the end of the agreement’s five-year term, Sandoz has agreed to exclusively sell the authorized generic version of Adderall XR supplied by Shire.

      Shire will manufacture and supply Sandoz with all dosage strengths of the authorized generic product. Sandoz will distribute the product in the United States. Shire will receive a royalty from Sandoz’s sales of the product.

      Perhaps it’s a matter of finding a pharmacy that stocks it? As I said in the round-up piece, sometimes the mail-order pharmacies have the best supplies. The local pharmacy seems to not keep a readily available stock, and there is also the issue of the cheaper generics being more profitable.

      As for putting more kids on Adderall, please no. I know it helps some people, and is the best choice for them. For many others, it causes more problems than it solves. I’m convinced the over-prescription of Adderall is in large part responsible for the backlash against ADHD and specifically the medications used to treat it.

      If you do best on Dexedrine, you might do best paying out-of-pocket for it at places like Costco.

      Good luck!

  6. I have used all 3 generics forms of Concerta and Mallinckrodt is BY FAR the most effective of all 3 manufacturers for me personally. All that this is going to do is raise the price of everyone’s medication – moving forward I will simply have my Doctor write my prescription for Methylphenidate ER versus Concerta so my pharmacy can fill what I feel is the better medication.

    1. Luke,

      I’m glad you found an Rx that is effective for you.

      Perhaps if Mallinckrodt called its generic something else, that would be fine.

      But it’s claiming that it is bioequivalent to Concerta, when it is not.

      THAT is the issue.

      Read the other comments from people for whom these generics were a sorry substitute, and you’ll see the problems.


  7. Wow, I can’t tell you how thankful I am to come have come across this website. My son has been on Concerta 27 for a little over a year with great results. He has received a generic for each fill, but it had always been “the good one” until this last refill. Holy cow, it was night and day difference for my child. There have been more tears, emotional outbursts and general unhappiness than we’ve had since before he was diagnosed.
    This holiday break has been miserable for our whole family. I finally called his doctor this morning, and she just scratched her head and couldn’t figure out what could be different. Maybe it was just the stress of the holidays she said. But one of her nurses did some research and came across this information. She called every pharmacy in our area until she found one that carried the authorized generic and she got us a new script. Hopefully tomorrow, we can begin spending the rest of our break enjoying our time together. Thank you for getting this info out there. I’m so angry that this drug company messed with people in this way.

    1. Hi Stephanie,

      Wow, that nurse went way above and beyond the call for you and your son. Good for her.

      Yes, it’s pretty shocking how a generic manufacturer can manipulate FDA loopholes for profit, no matter the risk to the humans taking the medication. I’ve read some of the business reports. The Mallinckrodt CEO is clamoring about the unfairness of government. Ha! I’m preparing a little post for him soon. If he and his company’s shareholders have no conscience, at least they can have a public shaming.

      Best of New Years to you and your son!

      Gina Pera

  8. This is the best news! Like many others, I stumbled across this website when I received my Concerta rx in the Spring that didn’t look like Concerta and turned out to be manufactured by Mallinckrodt, and I subsequently filed a complaint with the FDA. I’ve been on Concerta for 11+ years and it is the best drug therapeutically for me but no matter what insurance company I’ve been on over the years this drug has caused numerous headaches whether it be cost, generic issues or what have you. It is so nice to feel like we finally got a win.

    For people wondering about availability and pricing this is what I found out — I have United Healthcare and use OptumRx mail order pharmacy:

    Not knowing the Concerta generics were downgraded, when I saw my ADHD doctor last week I complained about the Mallinckrodt version and he wrote my rx for Concerta and substitution permitted for the Actavis version, but said it may be an issue especially with mail order since most pharmacies aren’t carrying this. I decided to call my pharmacy today, OptumRx, to see if they carried it before I mailed my rx in. After being on hold for 15 min. I was fully prepared for the bad news. However, the customer service rep came back and said while they don’t have the one by Activas they had the real brand version of Concert from Jannsen. It turns out, the brand version is now cheaper than the so called generics. I asked how this happened and she explained it was because of the recent events with the FDA that my insurance now finds the brand to be the best option therapeutically. I am so happy to get actual concerta and not have to pay $400+ for it (I take a 54mg and 36mg each morning so I pay two copays for this stuff).

    I am so happy for everyone who has shared my same struggles…now lets hope this lasts!

    1. Hey Katie,

      Congrats on the good news, and thanks for sharing it with us!

      I’ve been trying to get a bead on what’s what, with the recent downgrading. And it seems such a mixed bag.

      So much of pharmacy policy is left up to the individual insurance policy, and the types of negotiations done by the employer, etc.

      I’m really happy that you are getting the real deal at an affordable price. Happy New Year!

      Gina Pera

  9. So glad I found your blog post. I hadn’t heard about the problem with the generics until yesterday. My daughter takes the Actavis produced generic Concerta without issue. We changed her dosage last week, and got sticker shock at the pharmacy when we went to pick it up. My insurance company told me that the FDA no longer considers that particular generic a ‘generic’. I can’t seem to find any information on this issue, and it seem coincidental that this happened at the same time the other two generics were downgraded. Just curious if anyone else has encountered a cost increase with the Actavis generic? I mean, it’s not an astronomical cost compared to what many have to pay, but when our plan allows children’s generics with zero copay, it’s definitely a budget buster. I’m wondering if my insurance co has the correct info.

    1. Hi Karen,

      So sorry I’m just now seeing your comment. WordPress has been goofing on me.

      Your insurance company is wrong. The Actavis generic IS the brand, and it is marketed as a generic. It has NOT been downgraded, as with the generics by Mallinckrodt and Kremers-Urban.

      What is more likely is that your insurance company, as happens this time of year, is changing its policy. It has probably removed Concerta from the formulary entirely, in light of the cheaper generics not being available any longer. In other words, it is probably using that as an excuse to stop paying for the brand or the authorized generic. (It could also be that the brand and the authorized generic have taken advantage of the situation and raised their prices, no longer being in competition with the inferior generics.)

      I’d complain, complain, complain until you get some answers. Insurance companies can pretty much do what they like in this regard. But don’t let them tell you that the FDA downgraded the Actavis generic, because that is plain wrong.

      Good luck!

    2. While the FDA announcement has it’s good points, it also now it seems, has a real downside for users. I have found the same problem As of January 1, many formularies dropped this as a generic an stated that even the Activis was still a generic it was being considered a brand. The net effect for many will be a large increase in co-pays. I have been told that Activis did this because it had not competitors so it raised its prices. Some insurance companies purchased “generic insurance” so that if this happened, their formulary would not change. Others just change the formulary mid year whenever they want making it useless really for comparison purposes.

    3. Hi Bill,

      Yes, there is definitely some fall-out. We expected the problem you describe, unfortunately. Also, the limited amount of MPH has been tied up in these downgraded generics, resulting in a shortage of the other MPH products.

      I don’t have any great answers. I’ve been pondering an update post for a few weeks, wondering how it would all shake out.

      It seems the best that consumers to do is make a pest of themselves with the insurance companies and, when necessary, ask their MDs to write letters to the insurance company about why Concerta has been found the best option. Often, there must be some trial of the other choices.

      Good luck!

  10. Hi- Cost issues!

    Thanks to the explanation about the OROS delivery system, I understood why the Mallinckrodt product did not work for me. I had been filling my Rx at the local Walgreens and when I began to use mail order thru my insurance, I rec’d the Mallinckrodt product. I had used the generic Actavis b/c of the cost and as described in the blog, it is the same as the “non-generic” by Actavis. My concerns are now about the cost of the generic made by Actavis. I was paying for the medication outside my insurance b/c it was about half the price – under $600 for a 90 day supply of 54 mg ER thru my insurance or $250 with a discount coupon I found on the web. (Don’t know if I should name the issuer of the coupon.) Yesterday, I discovered the cost of the 90 days supply at the local Walgreens increased to $328. This is a significant increase! I am concerned about the current cost – AND the future cost since the agreement allowing the sale of the generic Actavis product ends in a few weeks at the end of calendar year 2014. I called the issuer of the coupon and was informed the price increase was the result of a price increase by the manufacturer. Any information you can share would be appreciated!
    Thank you.

    1. Hi Meg,

      1. I’d be happy to share with readers where you found that coupon!

      2. Many Rx manufacturers will make coupons available at their website. (There is also a financial assistance plan for those who qualify, for almost all Rx.)

      3. Things are in flux right now for a host of reasons:

      The market (drugstores, insurance companies, etc.) is adjusting to the downgrading of these inferior generics.

      This is also the time of year when insurance companies make policy changes — e.g. adding/removing Rx from the “formulary” (the list of Rx covered by insurance).

      On top of this, there is an apparent supply issue. There is a restricted supply of the ingredient in these medications (methylphenidate), and with so much tied up in the inferior generics, the supply seems to have gone short for a while. I hear that it’s easing.

      4. Last I checked, the Actavis marketing agreement with Janssen had been extended to 2017. So, that’s one piece of good news.

      I am working on a “roundup” post of all these factors. It has been tough getting a sense for all that is happening!

      Good luck!

  11. Krista Johnson

    I stumbled onto this while researching my daughter’s meds. She takes Methylphenidate ER 36 in the morning and then methylphenidate 10mg after school if needed.

    I was curious after reading an article on how some of the generic meds to last as long. I talked to the pharmacist today, and she told me that some of the generics had been downgraded, but the ones they were using were not. Well, the one brand is Kremers Urban. Should I be looking into this?

    The meds work just fine- I’m just annoyed that the supossed 12 hour dose sometimes only works for 8???

    Thanks, and I’m looking forward to reading more from you!

    1. HI Krista,

      So sorry for the delay. WordPress malfunctioned and I wasn’t notified of your comment.

      To be clear: The two downgraded Concerta generics are made by Mallinckrodt and Kremers Urban. So, if your pharmacy told you otherwise, I’d find a new pharmacy.

      If the Kremers Urban generic is working well for your daughter, great. But are you sure it’s working as well as the brand Concerta (and authorized generic from Actavis)? And if it’s not lasting as long as the brand does, then that is a problem.

      Good luck!

  12. Anyone who can help, I was able to find Watson labs concerta back in October. At first I was on keeners urban and mallinkrodct but found a new pharm because keeners caused a lot of ups and downs. So last week I go to get my script filled and they give me the mallinkrodct generic I guess the Watson generic is on back order. Now they are substituting it with mallinkrodct, first this pisses me off because the pharmacist had no idea when I went there about the fda downgrading the others until I told him. And secondly Watson is on back order I guess anticipated since sep. I’m wondering what can I do the fda says it could last through 2q15 and I already turned in the script. What can I do to get the Watson generic. I need the medicine and I feel handcuffed. Any help would be greatly appreciated.

  13. I may be the only one, but I’m actually disappointed that the generic manufactured by Kremer Urban has now been downgraded as well. My son has done beautifully on it. On the authorized generic manufactured by Actavis, he suffers from recurrent panic attacks.

  14. My biggest question is: what are the negative side effects from taking the generic brands that don’t meet the FDA requirements? I started taking “Concerta”54 mg 2 months ago to treat my ADHD and depression.. I noticed SOME positive differences but my irritability is definitely not better and I noticed waves in my energy level that are a bit strange. And if I drink caffeine, my HR is crazy! I would have NEVER known about the two generics that have been downgraded until today when my pharmacy said they needed to call my doctor to make sure he is ok with me taking the generic rx (since the one they carry is one that has been downgraded)! I started doing my research and called every pharmacy in town to discover that Sam’s Club carries the Actavis generic – they are the ones who explained that this is the only generic identical to Concerta name brand. Looks like I will be heading over there! Hopefully the results will improve now that I will be taking something that properly formulated! Thanks for any advice/comments in advance!

    1. Hi Kasey,

      Well, let’s hear it for that pharmacist at Sam’s Club!

      You wrote: My biggest question is: what are the negative side effects from taking the generic brands that don’t meet the FDA requirements?

      First, it is important to understand that all the methylphenidate formulations (Ritalin, Concerta, Daytrana, etc.) contain the exact same medication. The difference is how they are delivered to your system. For example, is the medication delivered in a big lump, or is it slowly released over a period of time?

      This “delivery system” can make all the difference in the world for some people.

      Concerta uses a highly sophisticated osmotic pump that delivers the medication slowly as it travels through your GI system. (The capsule is actually excreted; it does not dissolve.) And it does it with a certain profile — roughly, steadily ascending and then slowly descending.

      The problem with the generics is that while Concerta’s “profile” looks like a smooth curve, the generics are all over the place, up down up down up down up down.

      So, any “side effects” will be from that less-than-steady delivery.

      I hope this helps. I will be posting more as this issue develops; to be notified, please subscribe to my blog.

  15. I just found this web sit today. I am adhd adult 40. I was so happy when my wife brought my pills home today. I was like wow I got real conserta! It maid so mad when the pharmacist at C_S told me I was wrong because I told them there pills suck it was like I didn’t even take my meds. Then went to krogers and the pills they had kind a worked. Now they have the ones maid by jj. I am so happy my wife thinks I am nuts but I feel she will understand once I start taking the good stuff!
    Thank you
    Thank you

    1. Hi Mike,

      I completely understand your happiness. Hurrah!!!

      As for those pharmacists who are “gaslighting” people buying these **** generics, I’d like to tweak their noses!!

      Good luck!

  16. Can someone help me here – My girls are on generic Concerta 18 & 27 – our last fill was all Alza products and today I picked up Alza 27’s and Round Pink 18’s from Kremers Urban Pharmaceuticals – I can not find pictures of the generic’s you talk about above nor any information on Kremers. But am wondering if Kremers is one of them or suspect as well??
    Not sure if I have been living under a rock or how I missed this issue in the news, but for sanity sake hope this explains some things….we have had these round pink’s in the past although I never kept track of what we had from month to month and CVS is constantly switching it up on us and assures me there is no difference…THANK YOU!

    1. Hi Caroline,

      It’s not like you missed this in “the news.” My blog is one of the few places you’d learn about this issue with the Concerta generics. 🙂 (I will be writing a “summary post” on this soon. Please subscribe to my blog if you want to be notified of updates.)

      The bottom line: If it doesn’t say Alza on the pill, you have one of the downgraded generics.

      It’s a shame, but many drugstore pharmacists are clueless about these generics. Or else they are giving the party line. (These generics are more profitable to the drugstore.)

      Readers have indicated that Walgreen’s is more reliable than CVS in getting the brand or the authorized generic (which IS the brand, just marketed through an agreement as a generic). Overall, I encourage folks to use mail-order, if they have that option. You get a larger supply, at lower cost, and there is a better chance of getting the better products.

      If the Kremers Urban worked for your child, then no problem. But, if it didn’t, you want to tell the pharmacy that these generics have been downgraded by the FDA.

      I hope this helps.
      Gina Pera

  17. Great, except now no one has the generic by Actavis. Can’t find it anywhere. And… The pharmacy won’t fill my script that says Concerta generically unless it’s with the Actavis version.

    Doc has to rewrite the script to read “Almost Concerta” or maybe “Close, but not quite Concerta”. Just kidding about that, although he does have to rewrite it as Methylphenidate ER 54 so I can at least get the crappy version until pharmacies start stocking the authorized version.

    You’d think a little forethought might’ve been put into this and maybe the pharmacies could have started stocking Actavis before they were instructed to stop filling with the substandard version.

    1. Hi Douglas,

      I’m not sure exactly what you mean.

      But, to be clear, that’s what you want: The Actavis version. That is the exact same as brand. It’s just sold as a generic due to a marketing arrangement.

      The pharmacy should fill it with the Actavis if your doc writes Concerta OR Methylphenidate ER 54, as long as he specifies generic (or doesn’t specify “do not substitute”).

      Good luck!

  18. I read about this 2 days ago and discussed it with my nurse this morning. She had read this last week. Go to the pharmacy and they gave me mallinckrodt. I mentioned this and requested Activavis. They didn’t have it in stock but the rite aid across town did. Rite aid has not been told to not dispense for Concerta. The pharmacist told me they have to dispense until they receive the official update from the FDA, which may be next month. The other pharmacist told me that until they get that, my nurse needs to write it for the Actavis generic and do not put Concerta. That pharmacy keeps it in special stock for another patient fot this reason.

    1. Hi Suzanna,

      Good for you, for being a smart consumer. 🙂

      Yes, that was my advice in a post summarizing these issues: to ask the MD to write on the Rx “OROS only” or “Actavis.” Personally, I think OROS is the more reliable option, as these companies seem to change their names with the change in the weather. 😉

  19. Wow, Bruce! That’s fantastic!! $7!!

    And hey, big hugs from me to that pharmacist. He/she went above and beyond, truly serving patients’ needs instead of store’s bottom-line profits. Yay!

    Thanks for writing!

  20. A great victory, and a great demonstration that we live in a country where individuals can have significant influence!

  21. Penny Williams

    That is fantastic news! My son has been getting scripts with “name brand medically necessary” ever since those two generics came out. It was like my son wasn’t taking any meds anymore on the Mallinckrocdt generic. It was a huge hassle to get insurance to approve it, and we pay more for it. I’m going to ask our pharmacist right away when they will be stocking the Janssen/Actavis generic again! 🙂

    Penny Williams

  22. Gina,

    Thanks for this news!

    The FDA MedWatch reporting site (where you scroll down to consumer) is here:

    I didn’t do it anonymously and I had some major issues with the Mallencrocdt generic. Hearing my phone ring and then say “Mallencrock” in its automated voice got me out of bed on an otherwise bad day. I answered yes to all their “can we contact…” questions and when they asked if I told my doctor about these adverse effects, can he verify blah blah… I said yes, it was a long time ago and I’m not sure how much detail I went into but if nothing else, he WILL remember that I had problems and asked him to start writing my scripts (the way Gina suggested).

    I saved the pills someplace special where they wouldn’t get thrown out when they expired and to this day I cannot find them!

    I had the good fortune of my pharmacy giving me half OROS and half Mallencrocdt and a pretty bad reaction that was reproducible in an A B A B A comparison with the Watson OROS consistently being fine and the Mallencrocdt consistently not.

    This was my first experience with both that dose, which has been the right dose, and a true generic. Had the timing been different, a little later (i got the last of the OROS pills, all on the bottom with a tissue separating them or something), I may have thought the problems came from that dose and not realized I didn’t do well on the generic.

    A former doctor once told me to keep track of the brand of pill I was given when another med I was on went generic years ago and explained to me in GREAT detail all the differences there can be. It was great advice. Different generics can produce drastically different results, especially if you happen to have a sensitivity to an inactive ingredient… Instead of just changing one variable, the dose, two were changed – the dose and the brand. With pharmacists preaching they’re the same (not mine), so many wouldn’t go back to that dose. Luckily I already knew better.

    If you want to get a good feel for delivery mechanisms, compare the fine mist produced by Afrin vs the store brand. If you want to be banned from your pharmacy, use this to demonstrate that you know the active ingredient may be the same, but the generic is NOT the same. Make sure to prime the pump. For added fun, get one with menthol in it and one without. Hey menthol isn’t the thing that’s the same… Be sure to make a huge mess with the store brand all over the counter and pharmacist. I suggest dousing the pharmacist with menthol like you are a perfume sprayer in a department store. Make sure it’s not a pharmacist you like if you choose to use a visual and olfactory and tactile aid such as this when showing your knowledge about no it’s NOT the same. Purchase the nasal sprays before doing this (i suggest paying in front if it’s a big store) and have your receipt on you. If you are lectured by a pharmacist you really can’t stand, it is often possible to get a pretty good stream out of the store brand by turning the bottle sideways. Now you have a squirt gun if you’ve practiced. Aim for an article of clothing other than the white coat. Oh and this is important. Make sure you have paid for and have in your hand anything you intend to bring home before you show the pharmacist, using very effective props, that you know your stuff and will not tolerate their deceit. Because when you are done, you may want to run as fast as you can, preferably right before security is called. And be prepared to never go back there again.

    In all seriousness though (trust me, you don’t want to do this demonstration at a pharmacy you ever want to go back to), I said “sure store brand is fine” when I was sick and needed Afrin. I didn’t realize the pump would render the store brand useless… After I did a facepalm for wasting a lot of money trying to save a few pennies, I thought “wow what a perfect illustration!”

    I knew something was funky when my shiny new generic Concerta had the exact same appearance and imprint as the brand. My pharmacist told me there weren’t any generics yet and I was getting a good deal on the brand. And then I found this blog and learned about true generics and the whole confusing story and got myself into a grandfather clause with my insurance this year to not pay out of pocket for brand. I don’t know what I’m gonna do in 2 years when it ends except hope they add a medical necessity clause for exceptions or alza’s patent expires or they license it to generic manufacturers or something…

    Thanks for all your hard work, Gina, in keeping us updated, and everyone who reported adverse effects. The lady from Mallencrocdt was really nice by the way. They really do want to improve the product. I want to be able to afford a med that works. I’d like to see these pulled from the market but I didn’t mention that part. To me, it’s just time release Ritalin and can’t be called Concerta without OROS. And I’ve seen OROS used in another class of drug too. It seems to agree with me. It’s what makes Concerta Concerta.

    Thank you for all the info you’ve worked so hard to gather and thank you to everyone who reported adverse effects. Let’s keep spreading the word. Other countries have tighter controls on generics…


    1. Danielle — LOL!!! Menthol!!

      Thank YOU for doing your part in the effort. Kudos!!!

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