Generic Adderall XR – New Formulations

By Dr. Kenny Handelman

Adderall XR went generic in the US in April 2009. I wrote an initial blog post about it here: Generic Adderall XR. You can also review the nature of generic medicines in an article here: Are Generics The Same?.

While my initial thoughts were that the generic Adderall XR was very similar to the trade brand (made by Shire), the comments on my blog post made it clear that many people are finding that the generic version of Adderall XR just doesn’t work as well as it is supposed to.

As DS writes:

“After the first week, I really felt a difference, but tried to put it out of my mind. My shoulder and rib cage is sore, I don’t sleep and I am snapping at people all day, all night. This is not the same drug mixture/compound. It cannot possibly be. I feel tired from the lack of sleep, moody/agressive/weepy (not me!), sore (for no apparent reason) and just plain out of sorts.

Has anyone had any luck figuring out why some of us are feeling this hell-ish effect from the generic version?

- Sleepless (and crabby) in Seattle

The original generic Adderall XR was produced by the pharmaceutical company Teva.

Now, two more pharmaceutical companies will be joining the production of Adderall XR:

  1. Impax Pharmaceuticals will begin to ship its own version of Adderall XR at the end of 2009/early 2010. You can read more about this here.
  2. Sandoz Pharmaceuticals just settled a law suit with Shire (the original makers of Adderall XR) to allow them to make a generic version of Adderall XR as well. It is not clear when their production and distribution will begin. You can read about this here.

Why Are These Generics Coming?

When a pharmaceutical company creates a new medicine, they get a patent for a certain number of years. They spend hundreds of millions of dollars to get their drug to market, and then they have a number of years to profit from their medicine, before it goes ‘generic’ and other pharmaceutical companies start to manufacture the medicine (and they sell it for less).

Even when a medicine is within its patent, the generic pharmaceutical companies start law suits to challenge the patents – i.e. to see if they can start to market the drug earlier, and increase their profits. It seems that the companies that are now manufacturing and selling generic Adderall XR have pursued the legal process to challenge Shire’s patent, and they are now in the position to start to manufacture and profit from this medicine.

What does this mean to you?

Well, although I initially thought that the generic Adderall XR wouldn’t cause problems for people – there are 94 comments on my original blog post which essentially prove me wrong – i.e. many people are struggling with the generic form of the medicine.

Here is where it gets complicated.

If you used to be on the Shire Adderall XR, and then the Teva generic comes out – your pharmacy or insurance gives you the ‘cheaper’ version. Let’s say it doesn’t work as well for you, but because of the finances, or your insurance’s policy, you work with your doctor, adjust the dose and make it work.

Now, your pharmacy, or insurance company may make a deal with Impax – to get their new version of generic Adderall XR. Now, the formulation is slightly different again. Translation – you may have a different response or reaction to the new version of the generic than you did to the first one. You’ll need to go to your doctor, advocate at your insurance, and see if you can get on the medicine which works best for you.

Of course, if you can afford it – you can always ask your doctor for a prescription for Adderall XR – No Substitution (this means that your doctor is insisting that you get the original adderall xr only). The thing is that your insurance can refuse to pay for it, even if your doctor is that specific.

This can be complicated for you, or your child if you take Adderall XR. Best to monitor your symptoms, and work with your doctor to find the best solution for you.

Please share your thoughts and comments below. Your input is tremendously helpful to thousands of other people who come to this blog and learn from your experience.

All the best,

Dr. Kenny

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Comments

  1. Kermit says:

    WoW! For once it sounds as if Bc/BS is looking out for the consumer. XR name brand is much better than the generics. Don’t even consider using the Teva version of the generic. (just look at some of the horror stories earlier in this conversion thread.

    When I was off of insurance, and had to pay full price for XR, it was much better that getting cheap generic. Unemployment only goes so far, but it is better for me -not- to take Adderoll at all if the only choice is generic.
    The primary problem these days is consistency in the quanitity/quality of the name brand.
    ..

    I have not heard on anyone having a good reaction with any of the generics. Some one might have had good experiences with a generic Adderoll, but I have not heard about it.

    The usual issue with insurance companies is that they would only pay for the generic and not for the name brand.

  2. fred erikson says:

    I got the generic thanks to a screw-up at rite-aid.

    Figured- eh, I’ll take them back in a couple days if it doesn’t work the same.

    A month later, after taking 30mg/day for a couple years without incident, I can state unequivocally that this is not the same medicine.

    I’m ANGRY. As in FURIOUS. Not about the mix-up, but rather as a side-effect of the medicine. Plus, it does nothing for the ADD. Might as well be an angry pill.

    The adderall is so-so to begin with but I’ve tried everything else. This generic crap is a blue capsule with little writing on it [very tricky] but it is not the same medicine. I recommend that you avoid it if possible.

    The only thing that ever really helped was provigil. Blue cross wouldn’t cover and $23/day was brutal on top of my insurance premium.

    FU Rite aid for stealing a month of my life.

  3. fred erikson says:

    The other big difference that I have noticed is that I have had food & sugar cravings. Very big appetite change. This is not at all like me; other than this generic switch, I am pretty consistent.

    I actually got out of bed in search of candy/chocolate a couple nights ago [I'm easting a hershey bar thinking "why the hell am i eating this hershey bar?"]. It was like having the munchies.

    I talked about it with my wife the couple times it has happened, and attributed it to stress or whatever, but it is the generic xr.

    Basically, I have been out of sorts all month and am too dense to have figured out why. Presently making the connection that this medicine switch really mixed me up. If equivalent = identical, this generic adderall xr is not equivalent. The nonsense about it all being made by Shire must be just that – Shire has to be leaving something out of the mix to the generics.

    Two nights this month I woke up with charlie horse type calf cramps. This month also. This has not happened to me before.

    Very hard getting to sleep [good job on that at the generic factory].

    This was my first and last experience with this fake medicine.

    It should be assayed for purity – it is not right to tinker with peoples’ neurochemistry. Insurance, big pharma, they are all in cahoots.

    • Gayle says:

      I have been on adderall xr for 10 years and still got sugar cravings until I got some whole foods based vitamin supplements through my chiropracter (Standard Process brand). Within a week of taking chromium, magnesium and zinc (always tested low with regular supplements in each and chromium did the trick) my cravings disappeared. No one told me this would happen, I just observed that I no longer had cravings.
      I will never stop these supplements!
      The ADD I had all my life, that was overcome with self-discipline and no medicine, was severely exacerbated by a hemmorhagic stroke. The adderall just helps me maintain focus on my tasks. Of course it does have some hunger abating properties but nothing ever worked on the sugar craving until the supplements were begun.
      I despair the thought of having to give up the original formulation when we lose our corporate BCBS covereage at retirement. Just one day off my adderall and I lose all ability to focus on any subject or task.
      What can we do about companies getting to change the original formula by substituting lesser ingredients?

  4. JG says:

    After reading a number of posts, I thought I should check what I’m taking. I am 6 days from the end of my current Rx and have one ready to fill this week. So, in looking at the physical capsules of Adderall XR 30 (brand), I noticed something odd. On some of the caps, the text “Adderall XR” is printed on the clear end and “30mg” is printed on the opaque, orange end. On other caps, this is reversed. I also happen to take Lilly’s Cymbalta, which has green and blue ends on the capsules and both ends are consistently labeled. I expect this on-capsule print variation on Adderall XR points to a clear deficiency in process consistency…typically a no-no in the eyes of the FDA. I know…I used to work for Lilly.

  5. lakemcdougall says:

    I checked my remaining capsules — out of 20, 70% or 14 have Adderal XR printed on the opaque, 6 have it printed on the clear end of the caps. Very odd indeed. I have never checked before, but I will on all future refills to determine whether it’s the exception or the rule. Oddly enough, up until a month ago I too was taking Cymbalta and mine are labeled consistently on the dark blue end of the capsule. Will post results of next refill. thanks!

  6. kh says:

    Generic Adderall does not work for me. I noticed with the first pill that something was wrong. It has absolutely no effect on me. I wish the FDA and insurance companies would get their act together. Because this drug literally keeps me alive.

  7. lakemcdougall says:

    Amen. This drug DOES literally keep me alive. well said. Nobody gets that. thanks.

  8. KB says:

    Thank you to everyone who posted here, because I now do not feel like I’m crazy or that something is wrong with me. Not only is the generic not the same mixture, it’s also very inconsistent. I was taking the brand name Adderall XR because my insurance would not accept generic… I wondered why they would refuse the generic brand, but now I completely understand. They must know it is a ripoff as well. I was recently laid off and my insurance is no longer. Even though it is going to be very expensive for me, it is more expensive than monetary cost when you look at the positive aspects that the actual Adderall has had on my life. It’s not worth losing that by any means.

  9. AmandaLee says:

    My daughter had been on brand name Adderall for a year, then we switched her to a generic brand, because of insurance reasons. She did well on that generic brand for 6 months, then out of no where they quit working. For two months my daughter complained that her pills did absolutely nothing but make her nervous. So when I went in to get a refill at Walgreens they made a comment about the generic brand they carried had switched to Teva brand. So I went home and checked our old refill receipts/printout and sure enough right when they switched brands is when her meds quit working. We have gotten only brand name since then and she has had no complaints. We lost our insurance over the summer and are now looking into generic again, maybe global brand. I don’t know if I want to mess with the generic or not. I might just bite the bullet and fork out the $300 for the brand name.

  10. Teresa says:

    THANK YOU!!! THANK YOU!!!
    My son was doing great first semester last year on Adderrall XR 20mg, then everything went down hill second semester. We ended up DOUBLING his dosage which of course concerned me greatly. During a med check with the doctor, he asked of we were on the generic and the lightbulb went on! The change had occured right at that crossover point. We do not medicate on weekends, unless homework dictates, or long breaks and summer. This summer there were a few time he needed the focus for college apps, etc. and we did medicate. I had since gotten the name brand Adderrall xr in hand. I gave him that but DID not mention anything to my son. When I questioned him about his focus that day, he said it was great! Just like first semester! A week or so later he was working on a project and I gave him the generic and did not mention it. When asked about his focus that day, he had a very non-committal, “ehh” and he had accomlished a lot less!

    I’ve asked a couple of pharmacists about the generic and none think that should be an issue especially since it is made by Shire. With a growing teen it is hard to tell whether it’s med or growth related but after my own “blind test” I really think there is a difference.

    It is bad enough to have to medicate your child for anything on a a daily basis but to keep pumping meds into him with barely an effect other than the nasty side effects of appetite and sleep loss then have him struggle the way he had to second semester… I’m beyond furious! What can we do to being this to the attention of the FDA or someone who can correct the problem???

  11. alex says:

    @kh, you can live without adderall, you just need to gradually stop taking it or come to the realization that if you take this for the rest of your life, you will be facing some pretty nasty long term side effects down the road… at one point or another, everyone stops taking it cus they dont wanna die of a heart attack by age 30. just giving you a heads up cus your life wont last long on speed

  12. Dan says:

    It is IMPOSSIBLE for the generic adderall xr to “not work” It is manufactured by Shire, the same company who makes the brand and not a single ingredient is different. In fact, when it first came out, some of the generic capsules still said adderall on them!!! I am sorry, but when something is the same, it is the same. By the way, the same holds true for the Barr/Teva brand of the generic IR tablets, as they are manufactured by the same company, Teva as the brand. I find it interesting that people who take the brand name of this formulation had no problems when Teva bought the product from Shire. Teva, by the way is primarily a generic drug manufacturer.

  13. Teresa says:

    @ Dan
    Are you speaking as someone who works for one of these companies? I’m curious because after further research, I have learned that the “delivery” component within the medication can be different than the active ingredient. This can cause people to absorb the medicine at different rates. The FDA regulates the active ingredients and only requires the generic to be within 10% (over or under) of the amount in the name brand. They also DO NOT require testing as that has been done on the name brand and why the name brand is so expensive. So I was wondering if you knew if Barr or Teva was using another delivery method. Obviously each person handles each drug differently so if Shire is different than Barr and Teva, that possibility exists. I could be wrong but I thought I read that Teva and Barr bought the active ingredient from Shire not the entire product. Also, in checking with the Vons pharmacist, there is a Shire branded generic which my son was not on. I have to but mine from the CVS mail order and they use Teva. If I could buy from Vons, I would be wiling to try the Shire generic.

    Since my post, my son has been back in school. I have switched my son between the generic and name brand and there is a dramatic difference in results. He has no idea this was happening but would cpme home complaining about his focus level. I have since thrown out the generic. I also noticed the bottle noted Teva as the manufacturer. In doing more research and talking to

  14. Kermit says:

    It would seem logical that a generic from the same company would work almost as well as the name brand. The generic TEVA formulation is a disaster. In almost all cases, the current counter indication for the TEVA version requires that it _not_ be used in patients under 21. As far as I know, the other generics do not have this listed as an issue. That the others have different issues, is well understood.

    I think we all would want the generic Adderall to work as well as the name brand. It would be so much less expensive. In practice, most of the people that I’ve met that use prescribed Adderall have had major issues with each of the generics.
    The frustration level because the shire generics are so much trouble is incredibly high. We all wish it were otherwise.

    Three sets of pharmacies (local in texas, kroger, Walmart and CVS) have not been able to get the generics because of the current recall. (The recall was given as the reason for the back order) No problems if you want the brand name version..

    just a side note: Working with the doctor, I reduced the dosage of the Adderall (in conjunction with blood pressure issues) and added the use of Deplin. The theory is that it reduces the threshold of XR related transfer.

    I don’t know enough to say that it increases serotonin uptake or that reduces loss via membrane transfer.

    summary: Moving from Adderall XR to a generic should be watched carefully. In many cases, the changes are dramatic but because of situation, the patient doesn’t detect that the changes are due to the change of formulation. Many people have an increase in bad symptoms. Most teens and many adults have increases in suicidal thoughts.

    On two occasions (once because I didn’t understand the difference, and once because the pharmacy disregared the notice of brand-only) when I change to generic, my attitudes and impulsive reaction lead to situations where I got fired.
    Twice. Finding good work is really hard these days. Brand Name adderall is much cheaper than being unemployed.

    Not using any form of Adderall is safer than using the generic form (currently)

  15. Bret says:

    generic or not, how about the suppliers get some product on the shelves so we can get our scripts filled … it’s a bit frustrating running all around town trying to find a pharm that has product in stock.

  16. solo says:

    Can a company claim patent for compounding two generics into a fixed dose combination?Also can a company get patent protection for reformulating a generic eg an injectable-(original) to a patch?

  17. LANI FELIX POTTER says:

    I have been taking Adderall XR for more than 10 years. My doctor always prescribes the name brand only…. no substitutions allowed. When I inquired, he explained that as a doctor in the army, the pharmacist who was in charge of ordering all the drugs, medical supplies etc, told him that he never ordered generic drugs. He further explained that generics have a 17% window… meaning the active ingredient can be 17% higher or lower than the name brand, without any way of knowing, as well as varying binders from varying generic companies. The FDA allows this 17% variance…. Remember that the next time your doc writes you a prescription.

  18. LANI FELIX POTTER says:

    Also…. Shire has since sold their patent for Adderall XR to Barr pharmaceuticals, so don’t be alarmed if you see the name Barr instead of Shire on your name brand Adderall XR labels. Hope this helps.

  19. Dan says:

    @ Teresa
    It is true that for some sustained released products the release or delivery system may be different (generic Wellbutrin for depression and procardia for hypertension come to mind) but this is not the case for Adderall. Adderall XR is not a true generic. It is what is called an authorized generic where the originator contracts with a generic company to supply a “generic” but continues to manufacturer it and the two split profits. It is a ploy when drugs are going off patent that pharma uses to hold on to some money. This is why some insurance companies still price it as brand. The products, however are identical. I do not work for Teva or Shire, just a community pharmacist and if your son feels the brand is better, by all means ask for it. I have learned that that is a battle not worth fighting. I offer the generic as required by law, but if the doc or patient wants brand than so be it. In this case, there really should be no difference as they are identical down the the last excipient, but to each their own.

    • Teresa says:

      @Dan
      Thank you, as I appreicate you taking the time to write an explanation. He’s definitely taking a differrent dose with name brand at 20mg and the generic at 40mg. So for now while he’s in school, we cannot afford to experiment. But I’m willing try it again over a break as the generic is certainly cheaper. I have been told that an oral generic capsule content may be 7% over or 7% under the stated content, e.g. a 100 mg. capsule may be as low as 93 mg. or as high as 107 mg. Wouldnt’ that have an effect?

    • Mick68 says:

      @ Dan….It continues to amaze me that people continue to run to the defense of Shire and their fraudulent practices. I started my investigation of Shire and the generic issue a couple of years ago. I was switched from the brand name Adderall XR to Shire’s generic version of the same to try to conserve money, under the assumption that because Shire was producing the generic that it would be the same. Boy, was I wrong. After the switch, I began having major side effects-headaches, chest pains, racing heartbeat, pain in my legs, and EXTREME anxiety and panic attacks. I contacted Shire to inform them of what I was experiencing. The spokesman for Shire said, “They both come off the same line. There is no difference.” I told him that what he was saying made absolutely no sense at all. The generic cannot be the same exactly, otherwise there would be no difference in price, not to mention that they would not stop the imprint machine and then switch to the generic marked capsules. I also informed him that the blogs were full of such complaints. That is when they switched me to another department and I got the same run-around!
      I also called the FDA and filed a report with them about my experience with the generics. My wife and son both take Adderall XR, as well and they report the same problems. I mention it to my neuro-psychiatrist, who opened a drawer full of generic prescriptions that were turned over to him which he regularly sends back to Shire with formal complaint letters.
      It still makes no sense that the FDA approved Shire to stamp the name brand with both Adderall XR and mixed amphet. salts. The generic can only be stamped Mixed Amphet. Salts. I think this is complete fraud and unethical. Interesting that suddenly, there was/is a shortage in the generics as well as the brand name. It is my opinion that Shire will have to answer for this. I hope sooner than later!
      Unless you have actually taken both the name brand and the generic, then I would suggest you refrain from saying, “there is no difference.”. So my question to you is, have you taken them both? If not, then it would be advisible not to take sides in the issue!

  20. Dan says:

    @ solo

    Change in dosage form would be a new drug and require full approval not an ANDA. I would also like to talk about the so called 20% variance the FDA allows. There are virtually no drugs that vary by more than a very tiny fraction (maybe 1%) If they did, they would be fair game for other drug companies to say, look our product is 20% better than theirs. There is only one major drug that I am aware that the generic varied by this much (Dilantin, phenytoin) and the newest generic actually did a study showing that it truly has the same pharmacokinetic profile as the Dilantin. Now again, for Adderall XR this would not be the case as they are identical.

    • Mick68 says:

      Again, Dan, my question to you is, have you taken either the generic or name brand Adderall XR or IR for that matter? If you have not, then again I say, You have nothing relevant to add to this discussion except quoting your Rx manuals…I understand what they are “supposed to do,” That is not the issue here! We are all aware of what the regs are that pharma’s are expected to follow. In the case of Shire, they are not following them! You can say they are the same til you are blue in the face, but until you have tried them both in a blind test, then you do not have complete information. Quit telling us they are the same! They are not! Too many have complained and continue to complain about their differences. I spoke with my neuro-pysch this week about this issue once again. He is still having multiple patients bringing him the “trash” generic Adderall XR which he is sending in droves back to Shire. We are not all crazy. Shire will answer for this whether with the FDA or in court. One way or the other this will get exposed as FRAUD!

  21. Dan says:

    One more thing. Shire has not sold the patent to the XR version, only the IR.

  22. lakemcdougall says:

    The bottom line on authorized generics is unless you have actually taken them you really are not able to add anything relevant to the conversation. If we were able to resolve the medication issues we encounter by reading pharmaceutical literature, we wouldn’t need Dr. Handelman’s blog. We come here to discuss issues with others who have similar experiences, and to gain insights into the problems we face. I have taken the authorized generic (Teva) for Adderall XR 30 mg and the fact is, they Don’t Work. Period. Unless you have taken the medication, telling us they do work is ludicrous and truthfully, insulting.

    • Mick68 says:

      Exactly, lakemcdougall…I am sick and tired of hearing from pharmacists that they are the same! I always ask the pharmacists, “Have you taken either or both name brand and generic Adderall?” I always get the same reply. “No, I haven’t.” Well, then you obviously don’t know about the side-effects or the fact that the generic doesn’t work! Until someone has taken them both, they will never know. (Unless you start listening to the multitudes who have had issues with the generics)

      My neuro-psychiatrist has taken them both and has reported extensive side-effects, as well. You know, he knows this medication considering he has been in practice for over 35 years treating ADD/HD. (By the way, I started having the side-effects long before talking with him about it, so it isn’t just my imagining that there are differences.) Once I changed to the name brand, miraculously the ill-effects went away and I was back to normal.

      Bottom Line:
      I could care less what ANY pharmacist says until they have actually taken both drugs and endured what we the unsuspecting public have dealt with!

  23. Dan says:

    I do not have ADHD, so fortunately do not need to take Adderall. If you read my posts I said if you feel the brand is better, by all means ask for it. I really am an advocate for patients and like to give them what they want. I do not work for Shire, never have, and personally feel that pharma does do many conniving and borderline unethical things. However, unless they are utterly lying about their manufacturing processes (which I have no way of knowing), I stand by my statement that they are the same. They can price them differently because it costs them next to nothing to produce them. You are paying for R&D costs when you purchase drugs which can be billions of dollars. You guys are getting hostile for no reason. If you ever came to my pharmacy and asked for brand name anything, I will give it to you and not think twice about it. But, anectdotal evidence is not true science, and psychiatric conditions do not have measurable metrics, so it is very diffIcult to say that this drug can lower this or raise that when talking about diseases of the mind. Any doctor or pharmacist knows this but wants to see their patients improve, so if they feel the brand works better, no medical professional in their right mind would tell them they have to take the generic. But, people are putting false info here. There is no difference in indication for age as someone said. Shire did not sell the patent to XR as someone said. There is no difference in release mechinism as another said. I am just trying to be helpful, but would NEVER, AND I MEAN NEVER, tell a patient to take the generic if they do not want it.

  24. Dan says:

    Dr. Handelman,

    With so many complaints over the generics, even the authorized ones are you aware of any legitamate clinical studies testing this? I remember reading ones in school about non-psych drugs but never have seen one for ADHD drugs.

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