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. ivytamwood says:

    Adderall XR was wonderful when I had good prescription coverage. Then I had to go to generic Adderall, which was okay, until they removed the Barr version and gave us Core Pharma. It was a nightmare and I am not the only one – everyone all over the internet have made big complaints about this nasty pink pill. I kept finding pharmacies who distributed the Barr version but now it has been discontinued. I have been hoarding the last few, breaking them into pieces and suffering with severe ADD. I am wondering if these XR generics are any good. I just don’t know what to do and my psychiatrist doesn’t seem to know much about ADD so I have to do the research myself. But I’m really confused about what to try. I could pay a ridiculous price for the real thing and try to fight my insurance company for payment, but I doubt I will get anywhere. Any ideas on this stuff?

  2. I would suggest trying Adderall XR – it is once per day, lasts 12 hours, and a great medicine. The issue now – is – around which generic version is available to you.

  3. loribeth says:

    I was taking Adderall XR through their patient assistance program for nearly 3 or 4 years when they suddenly cancelled the program and I was forced to take the generic regular Adderall which for me does not work as well. I have to pay for the Adderall XR myself and when I tried to get the generic I found that the cost was still way too high for me to pay ($375.00 for 60 ct, 30 mgs) could you please look and see when the cost will finally come down and why is still so expensive?

    Thank you sincerely, loribeth

  4. Mike says:

    I had switched over to 30mg of the generic a few months ago, and hadn’t consciously noticed a difference. After reading this post, I dug out a couple spare non-generic Adderall XR, and tried them Sunday and Monday. I could immediately tell the difference. I was now calmer and more patient. At work, yesterday, I was able to focus WELL past 4pm, which is where I had been dropping off. Upon reflection of the last few months, my performance at work had dropped, and I can think of several incidents where I had inappropriately lost control.

    I’m wondering if the generic formulation is simply coming up short, for me. My experiment, though brief and hardly scientific, has convinced me to switch back to the name brand.

  5. Moktarino says:

    I had good luck with amphetamines, but always felt like a robot. So I switched to nicotine.

  6. not to get into too much detail on my past, but yeah i used to snort more than that all the time, the first time I ever did was a 30mg and then proceeded to do like 5 more one night… you should be just fine.

  7. KD says:

    The first time that my son received the generic, right after Teva’s Adderall XR generic was approved in April, he tried to jump out of my car while driving down the highway and told me he was going to kill me. My son was in Kindergarten. His behavior had dramatically declined the week and a half that he was on it. I returned it to the pharmacy, told them what had happened and they exchanged it for Shire’s brand name for me. Well, maybe exchange isn’t exactly the correct word since they charged me the difference in price.

    Since then, we’ve asked our Pediatrician to only prescribe the brand. Every time we get a refill RX, we have to get it corrected for brand name only. This time the pharmacy dispensed the wrong medicine. That’s what I get for sending my husband to do an errand for me. :) We couldn’t figure out why his behavior started to change. Thank God it wasn’t as bad as before, but school and his before and after care program complained and life pretty much stunk at home. Supposedly its been marked in his chart again at the pediatrician’s office and his ‘profile’ has been flagged at the pharmacy as “Brand Name Only”. It’s a good thing he is not deathly alergic to something. Its interesting that CVS won’t provide us with a copy of the original prescription. Its also interesting that they do not track the lot numbers of the medication that they distribute. I need to look into that. Can that really be legal? How would they handle a class 1 recall? It might be time to change pharmacies and send an email to the FDA.

  8. Linda says:

    I am taking generic Adderall XR (an orange capsule)and it is manufactured by Barr. I know the first person was taking Adderall by Barr and this is the XR, so maybe this is the only Adderall this company now makes. It seems to work well for me.

  9. Daniel says:

    I have been on Adderall XR 60 mg daily for the past 6 years. When the Generic (Barr) came out, I continued with the same dosage. Within two weeks my concentration was lacking, as if I had stopped taking the medication. Additionally, by 2:00 pm I was dead tired and actually ready to crawl in bed. (My work is pysical.) I begin to become unreasonably angry and even enraged at fellow coworkers to the point of initiating aggressive confrontation over the least little thing. I joined the ranks of “road rage drivers”. This was not me.

    I called my doctor’s office and left her a message. She had a new prescription for No Sub written up which I picked up and took to the pharmacy.
    The pharmacy said that my insurance company refused to fill it because I had just picked up a supply. I explained the situation and the pharmacy said that I would have to wait until the time period for the supply expired and then resubmit the prescription.

    I took it for two more weeks. When I went to the pharmacy they could find no record of the prescription. I called the dr’s office who faxed a copy to the pharmacy, but the pharmacy said that they only accepted originals for controlled substances.

    I went back to the doctor (took 5 days to get an appointment so I was without medication) and she was upset at the entire thing. She wrote a letter to the insurance company and gave me a new prescription. The pharmacy said that the insurance company needed a preapproval from my doctor to consider it, so I called the dr’s office and they called the insurance company. Five weeks after I ran out The pharmacy called and said my prescription was filled in name brand.

    The first dose was night and day difference. I had my old level of concentration back, could juggle two or three things simultaneously, and my energy level was strong into early evening. I also found my depression lifted. Even though I take 450 mg daily of Wellbutrin XL I had become more and more depressed. The end of the month came and the insurance company refused to refill the name brand again. They wrote my dr and said that she could appeal to an arbitrator and try to establish just grounds for the name brand and what they called extraneous dosage level. They only want to pay for 30 pills for any med. I tried taking three and four of the generic and my concentration level did increase, but my agitation, anger and aggression were just too much to handle. We are appealing to an arbitration board (comprised of insurance company employees) but don’t expect much success. And I am on Social Security disability for bipolar I, so it’s not like there isn’t a history for justification. Sorry I got carried away into the insurance thing so much. To sum it up, I have to say the generic I have experience with has a formula compounded of chemicals that induce depression in order to combat the levels of aggression, anger, and agitation the medication produces, and the entire formula seems weak compared to the brand name.

  10. Hi Daniel – thanks for sharing your story. That’s unbelievably complicated. I hope you and your doctor can get that sorted out!

  11. Jimi says:

    By the way…, Dr. Handelman, your blog and contributions to the topic of ADHD are very much appreciated. The subject is complex from a medical and scientific standpoint and (often in despair) consumers have needed such accessible advocacy. It’s long overdue… proper treatment of these conditions can be positively life changing.

    Oops, back to the topic… I’ve been treated with Adderall for nearly 5 years (XR, 20-30mg BID). I no longer have insurance (IP) and can not afford even generic XR (which my IP switched me to upon it’s release and was fine [Barr]). Moved to 15mg IR QID (split 30mg tabs) and noticed reduced efficacy (more “rollercoaster,” jittery, reduced duration of action (given same mg amt) with Barr 30 mg tabs. Clearly suboptimal but welcome considering the med’s profound positive impact. Then came CorePharma. MAJOR PROBLEM. I experienced a nearly 50% or more reduction in efficacy (focus, concentration), had drastically increased side-effects (fatigue 1h post dosing (?!), intolerable jitters). I refused to be ripped off/suffer the next month and found a CVS with one last month of Barrs stashed. RPh warned that next month would probably be CorePharma which I will not consume. Period. I’ll find an alternative somehow. Just my experience, phenotype disclaimers apply. Thanks again.

  12. Jimi – Thanks for the compliment. I appreciate it :-)
    I’m sorry to hear of your problems in getting the medicine.
    Can you please explain to me what CorePharma is? Is that a different generic manufacturer of the immediate release Adderall? Is Barr no longer producing the generic?
    And to help you out – are there any programs which may be able to help to pay for your medication? Either sponsored/subsidized by pharma or by government?
    Dr. Kenny

  13. Jimi says:

    You’re welcome, this really is an excellent resource.
    Sorry, although I initiated therapy with XR (DAR) I cant afford either the generic or Shire (which actually sold the XR to Barr), I have gone off-topic in mentioning the Core/Pharma IR failure. Either way this topic is about (Big)Pharma and is/will affect large numbers of patients negatively. I’ll try to put in an up to date nutshell… hold on…

  14. Jimi says:

    CorePharma/Ranbaxy manufactures the pink 30mg IR that has caused an uproar on many ADHD support boards for quality issues.

    Shire (orig patentholder of XR+IR) sold to Barr which was engulfed by Teva. Teva reformulated the IR also to poor consumer reviews and will be/is producing a reformulated/abbynormal original Shire brand. .

    Sandoz=Eon Makes IR form that may be the generic of choice based on several anecdotes.

    The death of the miraculous Shire brand Adderall XR has been pronounced by the financial talking heads and stock message board manipulators/shills alike. Apparently we have Shire to thank for bailing on “the Colonel’s recipe” XR product (off patent) in favor of the more lucrative Vyvanse.

    I’m starting to get the gist of this… correct me if I’ve misstated the details. Bottom line, the Barr XR generics I was dispensed weren’t that bad, but that was pre-Teva.

    The proper formulation of this medication is crucial to providing the gold standard for the stimulant treatment of ADHD. Thousands of anecdotes suggest that these reformulations may not only be inferior for therapeutic success, they also suggest that years of clinical trials and safety data may have been rendered noninformative. Unsettling to the consumer and prescriber, I’m sure.

    Again, chime in if you see errors.

  15. Sid says:

    Is it just me or are many of your side effects non medicine related? I have many of these symptoms quite often in a week including rib, chest, back pains sleep problems and depressed behaviors. But I think it could be due to mood swings, diet, not enough exercise or even an old mattress.

    I don’t know much about these medicines much, but I’m a 22 year old adult who haven’t taking any kind of medication or treatment since I was in elementary school (9 years old) Ritalin. I was diagnosed with ADD/ADHD (inactive version) and I think I was taken off of Ritalin after the first year because of head lice or something. Ever since then I have been living with it and school was a problem but I was a diligent and pushed my self alot to get things done. The problem with me is really the processing aspect where I couldn’t concentrate with the work and tests took me forever to finish but the teachers gave me extra time in tests. Reading and math was quite bad because i have to reread,remember and understand the steps to get it in my head, though my memorization was quit good for me. Another big problem i have is self-esteem issues so depressed feelings set in quite early for me. Shyness and inability to tell and reminisce stories gave me social issues when in group situations.

    Well enough about me.

    I guess now is really the time why I’m thinking of starting medication again since I’m in the working world and being fast at your feet and multitask is really important.

    I’m hearing more favorable accounts with Adderall XR then the other ones any objections?

    Thnks.

    Sid

  16. Hi Jimi,
    While I can’t say for certain – I can share my opinion.
    When it comes to the assertion that Shire ‘bailed’ on the Adderall XR patent – here’s my understanding.
    When a research and development Pharma company brings a drug to market – they invest heavily in the research and development. Estimates are that it costs upwards of $1 Billion USD to bring a medicine to market. The pharma companies are given a patent to market and sell their medicine for a set price (I know this is regulated in Canada – don’t know about how it is done in the US), for a set period of time. Then they lose their patent and generic pharma companies can start producing it.
    While people love to vilify the pharma companies – the reality is that they invest heavily in the development of medicines, and they (and their shareholders) need to see a return on investment – or – there won’t be any new medicines developed!
    So – that is all reasonably clear.
    Where it gets tricky – is that the generic companies start suing to break the patent well before it is supposed to finish. And, they can be successful in their lawsuits.
    Normally, big pharma fights these battles hard to protect their patent and their medicines.
    My understanding with Shire was that their patent for Adderall XR in the US was getting close to being near its end, and they were facing legal challenges from generic companies. My reading of the business reports online was that they decided to create a deal with the first generic company (Barr, I believe), so that there was essentially a settlement, rather than fighting a long drawn out battle.
    Of course, Shire had Vyvanse coming in advance of losing the Adderall XR patent, so their business model was certainly to promote Vyvanse before Adderall XR went generic.
    The unfortunate thing – as this blog post and all of the comments show – is the huge cost for PEOPLE who now can’t afford their brand name Adderall XR because their insurance won’t cover it, and the generic doesn’t work as well for them.
    Anyhow – thanks for a great and lively discussion.
    Dr. Kenny

  17. Jake says:

    Hi everyone,

    So it has been a while since I have used Adderall XR, probably 4-5 years, and I am trying it again. I am trying it again, since I am diagnosed with ADHD without Hyper-activity, to see whether it will help me stay focus on my schoolwork while in college. From what I have heard about the side-effects of the generic Adderall XR, I really do hope it will not affect me. Are these claims really true or do each individual react differently to it? Though, like I said before, it has been quite sometime since I have used it. Hope it goes well.

  18. Caitlin says:

    hi!
    I’ve been taking 30 mg Adderall XR for about 2 years now and will sometimes get the generic and sometimes get the brand name, usually depending on whats available at my pharmacy. I personally can’t tell a single difference between the way i feel or act when taking the generic compared to brand. The generic is by BARR. I think it works just as well as when i take actual Adderall. I usually try to get the brand name only because I pay 50$ a month for the brand, and still pay 50$ for the generic. Does anyone know why i pay the same amount for the generic? Isn’t the whole point of generic medications to lower the cost???

  19. Sarah says:

    Does Shire even make/sell Adderall XR anymore? Or is “Barr” the primary company now?

  20. Sarah,
    Shire still makes Adderall XR. To get it though, your doctor would have to write a prescription that says: Adderall XR NO SUBSTITUTION. That way, they have to give you the Shire version. That said, your insurance may or may not cover that.
    Best,
    Dr. Kenny
    http://www.SafeADHDMedication.com

  21. Sheila Kerr says:

    Hi,

    How can I tell the difference as to whether I am getting the real (Shire) or some other version of Adderall XR? I take a 30 mg pill, and I have noticed that some months it just doesn’t seem to work as well – but I haven’t noticed a difference in the colour of the pills, or anything…I thought maybe I was just tired or stressed or it was a ‘bad’ batch or something.

    Thanks

  22. Missy says:

    I’ve been taking Adderall XR for over five years with great results. Without my noticing, my pharamicist filled my prescription with the generic version. I started feeling terrible. I was constantly nauseous. I took a pregnancy test and it was negative. I went to my GP to see if I had an inner ear infection and didn’t. I lost weight and didn’t have any appetite. My GP couldn’t find any reason for my nausea. The next month I had my Adderall presciption filled at a different pharmacy and they gave me the name-brand and within a couple of days I felt like my old self. The next time I had my script filled I had to go to four different pharmacies to find the name brand.

  23. EM says:

    I too have been taking Adderall XR for years with great results. I don’t currently have health insurance and now have to take the generic form although it is expensive as well. After my last refill, I started experiencing terrible headaches and nausea everyday. I thought it could be from my medication but disregarded that because I hadn’t had the same side effects when I had previously taken it. I am now going to check into it more. Thank you for your comments and insight.

  24. Amie says:

    Today I tried to get my prescription for Aderall XR and the pharmacist told me that the prescription saying “prescribe as written” was not the same as “no substitution.” I had pointed this out to my dr’s office and they insisted that it was same thing because the name brand was written at the top. In my state, the pharmacy is required, by law, to substitute the generic if it is available. However, my insurance does not cover the generic. The pharmacy would only fill my prescription with the generic version.

    When I called my insurance company, they told me that the generic version had not been approved by the FDA. A second pharmacy told me that the generic version had been approved. Searching the FDA database, I cannot find an approval for a generic version of Adderall XR for 20mg. Is there an approved version of generic Adderall XR for 20mg?

  25. Amy says:

    Hello,

    I am a Psychiatric Nurse Practitioner licensed since 2003. I started Adderall XR 20 mg in 2002 (at age 31 for ADHD, inattentive type) which was a significant factor in my ability to complete my training program. I love psychopharmacology and have a great appreciation for its complexity. I am not sure I will ever master it as I seem to learn something new constantly.

    When I prescribe meds, I explain to patients that they should get a similar response with the generic that they do with the brand name but may very by the individual AND (possibly more importantly) their perception may have a significant impact on the response. I encourage patients not to decide on med choices based on what they hear from others and explain how important it is that they communicate and journal their own response. So… I tried to practice what I preach when switched to the generic Adderall XR. However, after changing from Adderall XR 30 mg brand name to gereric for the past several months, I started looking for feedback from others due to my poor response and decline in functioning. -With the brand name, within an hour of dosing, I am ready to go – focused, organized, with good energy. Taking my meds at 6:30 am, I seemed to do quite well until about 4:30. To combat the rebound, I would take a dextrostat 5mg about this time most days that got through making dinner, etc.. Since, taking the generic has been a whole different ball game. My sleep cycle is totally screwed up. I also take Wellbutrin XL 300mg and have for years but seemed to be getting more and more depressed. Within and hour of dosing, I have to go back to sleep and currently sleeping 12 + daily. It’s miserable. Usually about 4pm, I finally start waking up and have some energy but at 10pm, I am ready for bed.

    I never expected such a drastic difference with the generic and thought surely something else was wrong. In November I went to see my PCP and found that my vitamin D was a little low but now normal, otherwise medically cleared. Last week, I started an extensive work up for rib pain that has been increasingly bothersome and ongoing since August. I explained that it starts during the night and terrible by the am but once I get up and move around, it’s not noticeable. Of course, he immediately started asking about my mattress. I felt like such an idiot going to him with this weird somatic complaint so I had been going through all kinds of scenarios and symptoms with my husband (a radiologist) knowing that the PCP would likely think I was a complete fruitcake. —I was floored to see the above complaints of chest, rib, and back pain. Now I am hoping to put off the KUB and chest CT I am scheduled for.

    It is my understanding that manufactures of generics are only required to have 80% of the active compound (in the US). I also think that the “fillers” can effect the release of meds in the XR form. I have an appointment with my psychiatrist next week to discuss options. It doesn’t sound like increasing the generic will improve the response. I am wondering if I am getting significantly more of the active compound in the morning and being overmedicated then tapers to what I am used to in the afternoon. Also, I am wondering if the rib pain may be a rebound symptom since it starts at night and improves when I get up in the morning and move around (the same time I take my morning dose).

    Sorry so lengthy but I would greatly appreciate your feedback.

  26. Amy,
    Thanks for sharing your story. I have to say that i was a little surprised to see several reports of musculo-skeletal pain as a side effect of the generic, but there are a few people who have reported this on the blog.
    You also raise a very important fact – when a generic is made – it has to have an ‘area under the curve’ of 80%. This means that the amount of medicine in the blood over time has to be the same. It does not mean that the generic has to have the same absorption profile. So, it is possible that the generic releases its medicine more slowly, or more quickly – and could still be approved.
    I hope you feel better – and please do come back and update us. Having your medical background provides great insight for us.
    Thanks,
    Dr. Kenny

  27. Blaire says:

    i have been given 60mg a day but only been taking 30mg of the brand name Adderall XR for over 2 years now and it has been working fine. a few months ago my pharmacy messed up and gave me the generic xr but swore there was not a difference. i spent the month wanting to kill the pharmacy for putting me through that hell but the next month i got the brand name again and then a few weeks ago i went to fill my prescription and my insurance has decided to not cover the brand name anymore so i was forced to get the generics again. my doctor upped the dose to 40mg twice a day of the generic xr’s and 10mg of the instant release for the later afternoon (i’m in college for 12 hour days) well i have resorted to taking 60mg xr and 10mg instant together when i get up in the morning but i still am in a fog the whole day. my grades are showing the difference since i have gone from a 4.0 to making C’s and D’s in my classes. plus i have not been a very pleasant person at work for the last few weeks. i’m at the end of my rope with this whole generic issue.

  28. Blaire says:

    p.s i have also been itching during the day but it gets pretty severe starting at about 5pm every day since i switched to the generic xr. the most bothersome part is that the itching starts on my feet and hands and moves to my face and back. i have spoken to my doctor and he agrees that it sounds like a drug allergy. what else will go wrong! :-)

  29. Laura says:

    I have been taking adhd drugs for past few years. I am a 39 year old female with the inattentive type. About 2 years ago I switched to Adderall XR from Concerta. It was a wonderful and welcome change. When the generic adderall xr came out I tried it once and got horrible headaches and felt bad. After that, I switched back to name brand with no problem. Then, last Thursday…I filled my medicine…paid name brand price ($40 co pay) and received the generic labeled adderall xr imprinted with m. amphet salts. After many phone calls I was informed that both name brand adderall xr and the generic form are now labeled the same way…So, I paid name brand price for the generic…And was told by pharmacist and Shire that all name brand adderall xr is now labeled m. amphet salts now just like the generic…So, since I am back to having the horrible headaches that I had the last time I took generic,(Even though, it is supposed to be name brand) I am forced to go back to doctor to get a different medicine since evidently shire isn’t making the same name brand any more…and Adderall xr will not be an option since they seemed to have changed it….Has anyone else had same experience lately ( within past month this change has happened) If you have not experienced it yet…just wait!

  30. Sevenpetals26 says:

    IM SO LOST HERE!!! CAN ANYONE HELP ME??? WHY WOULD THE MANUFACTURER OF ADDERALL XR STOP PRODUCING PILLS. I CANT FIND ANY INFO ON IT AND MY SON IS ALMOST OUT AND IM SCARED THAT SOMETHING IS WRONG…. MY SON NOW HAS TERRETS BECAUSE OF THIS PLEASE SOMEONE HELP ME…..

  31. Sevenpetals26 says:

    I figured it out… they couldnt keep up with the demand but in all reality adderall is a horrible medication that isnt good for children at all…………………….. There are other ways…. I hope that anyone with issues figures them out and does well good luck all

  32. Jimi says:

    Sevenpetals, I’d be concerned with giving psychostimulents to kids under 12 without a thorough neuropsych workup especially with mild symptoms, but I’m not a physician. I will tell you that Adderall is probably not a horrible drug and I wouldn’t be surprised if (cost:benefit) (when it all works out in the wash) the treatment will likely save lives and prevent profound co-morbidity,including ironically drug and alcohol abuse. Go figure.

    Ken,

    Re: your response to my comment #14.

    You wrote (in part):

    >While people love to vilify the pharma companies – the reality is >that they invest heavily in the development of medicines, and they >(and their shareholders) need to see a return on investment – or – >there won’t be any new medicines developed!

    To clarify: I’m copasetic with big pharma/little pharma/anyone with a license maintaining their IP rights to the letter of the law, and grateful to the vast altruistic majority producing reliable quality products. However, in light of perceived (yet poorly scientifically addressed) product safety/efficacy concern, I’m left with a funky taste in my mouth over so many reports of inexorable responses from such a variety of companies.

    Also, I simply intimated that Shire may have “bailed on”/failed to disclose a specific formulation that may have prevented the perceived suboptimal transition to the generics. A major supposition, since it’s much more likely that the generic co’s chem whiz folks implemented their own formulations most amenable to their existing manufacturing processes (with no foresight of malice).

    So, from my continuing anecdote: 1) Both Shire and Barr XR formulations were life changing meds with excellent evidence based utility and safety in adults. 2) XR formulations (now generic and presumably of varying composition) remain expensive and now have uncertain bioequivalence (anecdotal). 3) IR formulations are affordable but seem significantly inferior to XR for a plethora of reasons. I’ll maintain my opinion that the mixed salt formulation (IR or XR) remains an excellent treatment option in select adult ADHD individuals with the caveat that drastic differences in overall drug action/side effects exist across the range (wild west) of generics (all anecdotal and simply my opinion). Thanks for the forum.

  33. Colin says:

    While my experience is simply anecdotal, I have had great success with the Global Pharmaceuticals version of Adderall XR. It has been smoother than the brand version, in my case.

    One side note, I’ve tried administering this medication with applesauce and that method works far better than I anticipated. For some reason, although I’m not sure how, the medicine lasts longer when the capsule are undone and the beads are sprinkled over the mashed fruit.

    Perhaps it has something to do with the body’s natural absorption of food. Whatever the reason, it’s been working, which is a great relief as I just switched to the generic version to save some money.

  34. Emily says:

    I have been struggling with rashes for a couple months, thinking I had a food allergy, now I am thinking it is because of a change in my generic Adderall XR. Has anyone else had this problem, and how do I know who the manufacturer is of my past prescriptions? I asked one pharmacist a couple months ago if he knew the manufacturer of my pills, and he said they don’t have that information! Thank you.

  35. GW says:

    I’ve been taking Adderall XR 25 for ADD since 2004 with great, life changing results. April of 2009 CVS switched me to a generic from Barr and I never noticed any change. It also worked great. 2010 CVS switched again to a generic from Global which does not have the same benefits and leaves me feeling anxious and irritable in the afternoon. This morning I spent a few hours on the phone with Shire and Barr Customer Service, and was told that Shire is manufacturing Adderall XR for Teva, Barr, Global, Impax, and Shire labels, and all should be the same, although they continue to receive many phone calls complaining of numerous and varying issues consumers are having with these generics. I spoke with five different customer service reps and none were able to move beyond the “company line” that “all should be equal” and give me real answers regarding how I can determine which generics are really the same as the Barr that had been working for me. I explained that I was just looking for some help finding a product that was manufactured at the same plant, or used the same formula as the Barr that had been working for me. I also asked, now that Teva owns Barr, is the Teva product the same as the Barr product? I got transferred to various departments, but never got any direction that might help reduce the trial and error aspect of finding what works and avoiding another 30 days of what doesn’t. Somewhere, someone has the answers to these questions. Those of us whith brain chemistry needs, should not be put in a position of experimenting to find which Adderall is the real deal. I understand that finding the drug and dosage that works involves some experimenting, but once you’ve found it they shouldn’t be allowed to take it and hide it from you, and essentially that’s what they’ve done. There should be a thread of info available to us to help us stay with our program. This has great impact on “quality of life”. It is much more than mere inconvenience.

  36. Ashley says:

    Has anyone had issues with Shire’s recent co-mingling of both Adderall XR and generic? I have been taking Adderall XR for the past 6 years to treat my ADD. I have had Cigna as my insurance for almost 4 years and have been able to get a 90 day supply of Adderall XR from Cigna through the mail-order pharmacy. I had no idea there was a generic form of the XR until this past week. I realized my last 90 day supply of XR was generic- all the capsules looked the same but the markings said “M. Amphet Salts” but the bottle said “Adderall XR” and I paid for BRAND. Plus, my doctor always writes “do not substitute” because I got bad headaches from the generic fast-acting Adderall tablets, and it didn’t work. (I take a combination of both XR and fast-acting). I honestly didn’t notice the markings were different for 2 months. But I had been feeling awful. I was so tired, unmotivated, had bad headaches, was very irritable and short with people around me. My productivity at work went way down, and I was so stressed. I thought something was wrong with my thyroid, had blood tests and went to my doctors to figure out the issue. Then a light bulb went off and realized my “M. Amphet Salts” AKA generic were the issue. I had basically been un-medicated for the past 2 months. I immediately called my pharmacy, and told them they made a mistake. Unfortunately, the pharmacist said that they have no control over the supply that Shire gives them because they now “co-mingle” both XR and generic together. Shire claims that the only difference between the 2 are the markings and the mail-order pharmacy fills prescriptions with machines, they don’t have the man power to sort out generic and XR capsules from one bulk supply that says they are all brand. So I called Shire, and they said over and over “both are branded products.” Well if that’s the case, I have a few questions: 1) Why would they take the time to produce a new stamp to change the markings on the capsules if both are allegedly the same?; 2) Why would I feel so different after 6 years of being on Adderall XR and this the first time I’ve gotten capsules with different markings? It’s ludacris.
    I filed a report with Shire and then turned to the FDA. I filed a complaint and it is part of an investigation. Turns out, the FDA approved the co-mingle last year. But they are still investigating the problems associated with that decision. I have no way of knowing if I’m the first to complain or one of many who have already complained.
    I had to pay $570 out of pocket to get a 30 day supply for the Branded capsules at my local pharmacy because according to Cigna, my original 90-day prescription was filled correctly since I paid the Brand price AND according to Shire, it was a “branded product.” So of course if another prescription went through for the controlled substance during that same 90-day window, it would be denied.
    It is so upsetting that Shire is getting away with this fraud. All I care about is being able to get the right medication, and it seems like it will now be a struggle. I can’t rely on the mail-order pharmacy, which was conveinent and cheaper. I will now have to get a 30 day supply filled at a local pharmacy for more money.
    Has anyone else come up against this? Shire called to me to offer me a free 30-day coupon for the XR capsules. What is that all about? All I want is my $570 back and to be able to get the right branded capsules. I don’t mind paying more for brand.
    I am now looking into finding others with this same issue to file a class action suit. If anyone has any advice or information to share, it would be greatly appreciated.

  37. Ashley says:

    One more comment from my post above: I forgot to mention that once I got the 30-day supply of the Branded capsules, I was back to old self. I was back to feeling energized, productive and less stressed. My co-workers, family and doctors could even tell the difference from my voice.

  38. lhl says:

    I have also found the generic Adderall XR to be ineffective and echo other’s complaints of having to take significantly higher doses of generic to get even close to the same effect as the brand. Also The start time is much slower, and duration shorter. For blood pressure reasons I need to cut back my Adderall XR dosage very gradually and very specifically (from 40 to 35 and then possibly 35 to 30). Generic adderall makes this enormously difficult -if not impossible.

    I do not understand why this is not sufficient reason for considering brand Adderall XR “medically necessary” in my case.

    Does any one know what the different criteria would be considered sufficient to meet that threshold? It probably varies with insurance companies, but any thoughts would be appreciated.

  39. Sonia says:

    I’ve been taking adderall xr 20 for five years. It works great for me. My 17 year daughter is adhd and takes adderall xr 20. I filled her presciption last week and got the generic brand. I tried a generic adderall because I ran out of mine. TERRIBLE!!! My hands feel cold and numb and I have brain fog headache. My daughter is coming home from school taking naps. She doesn’t feel it helps her focus for long. Why is this CRAP still on the market!!!!

  40. Mick68 says:

    I appreciate your blog Dr. Handelman. I wanted to relay my experience with Adderall XR to you. I was diagnosed as an adult with adhd 2 years ago. I started with 20mg of adderall xr and finally worked up to 80mg daily. I had amazing results. The fog literally lifted and I was able get things done, my confidence improved. My memory improved drastically. I was rolling along great until May of 2009 when my neuro-pyschiatrist told me about the generic of Adderall XR. I decided to give it a shot. I had lots going on in my life at the time, so I attributed the differences I was feeling to that.

    By September, I began to have chest pains, increased anxiety, pain in my legs, and headaches. I talked to my doctor about it and he said that many in his practice had the same experience. He suggested that I go back to the name brand. He wrote out the prescription, I had it filled and I was plodding along great again.

    I live in a different city than my doctor, so I have have to call for refills and receive the prescriptions through the mail. In December, I received the prescription in the mail, took it to CVS and had it filled. The bottle was a white Shire Adderall XR bottle and said manufactured by Shire. I began taking the meds and by the 2nd day began feeling like I did in September. Looking at the pill itself, I noticed that the imprint did not say, “Adderall XR” like they always had. It said, “Mixed Amph. Salts.” I checked online and found that someone had posted that Shire did not have permission to change the imprint. I then checked it out on the FDA website. At first, it looked as if Shire did not have approval to change the imprint. I did call Shire and they assured me that 1)the name brand Adderall XR and the generic came off the same line and were exactly the same, 2)the name brand could have either marking. I told the rep. that that was the most ludicrous thing I have ever heard. I said, “Do you mean to tell me that as a consumer, I have no way of identifying the generic and the name brand?” She responded, “You have to look at the bottle, sir. If the bottle says,’Manufactured by Shire’ then it is name brand.” To which I responed, “I understand that. Let me get this straight, you are saying that as a consumer that if I don’t look at the original bottle and I have two pills in my hand one generic and one name brand that I have no way to tell by looking at the imprint to know which one is which?” She respnded,”You have to look at the bottle.”

    I called the FDA the next day and spoke to them about my experience with Adderall XR and its generic form. I asked about the imprint situation and the FDA rep explained that Shire did have approval for the imprint on the name brand to say either “Mixed Amph. Salts” or “Adderall XR.” Again, I had the same “ludicrous” conversation with the FDA rep. She told me that the FDA had received calls concerning this, that the imprint was causing confusion and that they were in discussions with Shire. She said that any patient who fills the prescription and has adverse reactions whether generic or brand name go to the FDA website and report it. She said that so far they have not had many reports filed and until they do their hands are tied.

    I had an appointment with my doctor yesterday. He told me that his patients have been reporting adverse reactions to the brand name Adderall XR that is imprinteded with “Mixed Amp. Salts.” He has been advising his patients to make sure the name brand is imprinted with “Adderall XR.” So far, none of his patients have had issues with the brand name “Adderall XR” imprinted on the pills. He also informed me that Shire and the FDA had contacted him by mail to discuss the issues with Adderall XR. So, know that calling Shire and the FDA can make a difference. They certainly took notice and maybe it will ultimately bring about needed change.

  41. Mick68 says:

    Ashley, if you proceed with litigation, I would be happy to join you. I paid a co-pay of $194 for a 30 supply of “M. Amphet. Salts” imprinted on the capsules. I see this as major insurance fraud. I was unable to continue with them and had to switch to Concerta, which did not work for me. I have now switched back to Adderall XR and as long as the imprint says “Adderall XR”, then I am ok.

    Shire should be held responsible for this fiasco. The forums and blogs are filled with people who are currently having major issues with both the generic and name brand Adderall XR. I am glad that the FDA is getting involved, but how long will that investigation take. Looking at the way our government agencies handle things, I could be a senior citizen before it gets worked out. In the mean time, I am having to trust that Adderall XR that is imprinted as such is the real deal. At this point, I do not trust Shire.

  42. Mick68 – thank you for sharing your experience with this. It is helpful. I guess the message is that people need to let the FDA and Shire know if they are having problems!

  43. lola says:

    I have been taking adderall xr 30 mg. brand name, shire for about 6 days now. Was previously on generic instant release for one month, but felt jittery. The xr does not work. I took two yesterday and was spaced out. I called my insurance company to find out if they would pay for 2 per day. I need prior authorization to up the dosage. Don’t know what to do. I am preoccupied with adderall and I am afraid I am becoming psychologically addicted to this drug.

  44. JimV says:

    I have been on Adderall XR 10mg 2 times daily for approx. 7 years. Been great, able to focus and work like I used to. A while back I decided to try the Generic Adderall ER, per my insurance company. Within a month, my wife was ready to kick me out of the house. I was irritable, angry, tired, explosive temper, with no reason. She even called the insurance company and explained it to them, with the same reference, that she could not live with me since I started on the Generic Adderall ER.

    Switched back to the brand name Adderall XR, life went back to normal. However, for the past 2 months, I have been receiving (from Target Pharmacy)a bottle labeled Adderall XR and paying full price, but getting capsules labeled M.Amphetamine Salts. THIS CRAP HAS THE SAME SIDE EFFECTS AS THE GENERIC. I called the pharmacy, and they assured me this was a name brand version. I even showed them the Generic bottle (I had several left as I could no longer take them), and they were labeled the same as the so called “name brand”. I have had to stop taking the bogus Adderall XR, and will now be going from pharmacy to pharmacy to see if anyone acually has the real labeled stuff.

    I agree with the above posts, this is a load of garbage. And not being able to get a STRAIGHT answer from the pharmacies or the manufacturers is unacceptable. I, too, will be lodging a complaint with the FDA, and will try to get my doctor to do the same. Anyone with the same problems, I urge you to post a complaint, as this seems to be the only hope we have.

  45. Ren says:

    The posts here have been extremely valuable to me (thanks to all!) as I lie here, miserable on the sofa, too exhausted and headach-y to move, courtesy of the Teva formulation of Adderall XR 20.

    Taking cues from above posts – especially those citing the imprints on the capsules, whether Adderall XR ot Mixed Amph. Salts – and talks w FDA and pharmacists.

    I just read Shire’s 10-K form for year ending 12/31/2009.

    Here’s what jumps out:
    1. “The company sells the authorized generic version of ADDERALL XR to Teva and Impax and currently receives royalties from Impax on the sale of its authorized generic.”

    2. (Page 9)
    “Shire receives revenue from the supply of authorized generic ADDERALL XR toTeva and Impax.”

    3. (Page 17)
    “The company sources ADDERALL XR, … and Xagrid from a single contract manufacturer for each product.”

    4. The company’s US distribution center is in Kentucky. (This does not mean that Shire’s contract manufacturer of Adderall XR is in Kentucky, as speculated in an above post. Indeed, according to this, Shire doesn’t manufacture the generic Adderall XR OR the actual non-generic brand Adderall XR. Manufacture of all, if my reading of the 10-K is correct, is not done in Shire-owned facilities.

    5. In October 2005, Shire filed a Citizens Petition with the FDA about Adderall XR, generics and requirements of bio-equivalence and additional clinical testing. So far, the FDA has not addressed this petition.

  46. Kermit T says:

    Like many others, I’ve tried the generic from Teva and from Barr, and have had extremely bad experiences. At first, I didn’t realize that the problems might be caused by the med’s, but going back to the brand version of adderall XR was a night and day comparison. Today, when I went to the pharmacy, it was suggested to me to use the generic, because of the price difference. I expressed myself quite clearly on the subject indicating past extreme issues with the teva and barr products. The pharmacist showed me the generic which had a shire label. I was surprised that the capsules were identical (except for the number)

    Has anyone tried the Shire version of the generic? ($70 vs $470 for 30mg is a big differential) [[again, the Teva and Barr versions caused extreme problems. Going without any meds was an improvement until I got the brand version again.]]

  47. Mick68 says:

    Kermit T
    I tried all three-Shire,Teva and Barr. all of them are trash! Had major side effects-headaches, chest pains, racing heartbeat, pain in my legs, and EXTREME anxiety and panic attacks. Shire tried to tell me that there was no difference in their generic version and the brand name. 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!

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