Episode 15: Authorized Generic Vs Generic
This episode is a long time coming, I have been working on it in my head since October-ish. As you know, or maybe don’t if this is your first time listening, I have been on this medication roller coaster for a while and it has been a struggle. I think many of you know all too well how annoying, irritating, and frustrating trying to find ‘the’ medication for you can be. I had hoped that the pharmacogenomic testing would help narrow the options for me make it easier. OK, really, I hoped it would lead me straight to the medication that would be it for me, you know so I wouldn’t have to go through all of the trial and error. This whole process has been exhausting. With all of the work I have done to find fingers crossed ‘the one’ that works it disgusts me that anyone could think this diagnosis is fake or made up or just turpitude (sorry I don’t know where that word came from just popped in my head and I like it, lesson for the day it means immorality basically and yes I had to look it up to make sure I wasn’t making the word up..lol). Why would anyone put so much energy into finding not a cure obviously but something to help if it wasn’t real if we didn’t really struggle on our own. I wouldn’t there is no way.
PSA: I want to make sure I make this disclaimer very clear before I go any further with this episode. I am not a medical professional of any kind, I am not promoting any of the medications I have taken nor would I suggest that any of the ones I have tried are the “best” ADHD medication for anyone. A medication may be best for ME but I am one person with my own individual set of DNA and medical history that my doctor and I have referred to before making any decisions to try any of the medications I talk about. You have to speak with your doctor and take into account any medications you are currently on and your medical history before taking ANY new medication not just ADHD meds.
I would also like to suggest carefully reading the possible side effects and look for any contraindications with your current medications, In medicine, contraindications means a factor that serves as a reason to withhold a certain medical treatment due to the harm that it would cause the patient. Like when you see commercials that say do not take if you are on an MAOI or not to take a medication with certain supplements it’s the same type of thing. I now return you to your regularly scheduled program…..
Each new med I tried I hoped and prayed that it would be the one that would help me focus better at work and at home but each time I was disappointed. Let’s just recap all of my fun journey, after all that’s why I am here.
- Strattera (Atomoxetine) the only non-stimulant approved for ADHD treatment at least that I know of, if there are more please let me know. It works for ADHD but why is not exactly known but they have guesses. Straterra is also an SNRI or selective serotonin-norepinephrine reuptake inhibitor. What this means is that the level of the neurotransmitters are increased by blocking them from the reuptake by the nerves. A lot of antidepressants are SNRI’s https://www.mayoclinic.org/diseases-conditions/depression/in-depth/antidepressants/art-20044970. I had to take a pretty high dose for it to be effective but I think I was on 80mg by the end of a year being on it. It took a while before I started to notice it was working. I think I started to notice when I was at 60mg a difference. About 2 hours after I took it though I would get nauseous, but what I figured out was that if I ate at around the 1-1.5 hour mark after taking it I was fine. The other issue I had was that I was tired not just tired but I felt completely drained in the most literal sense. On the weekends especially I would get up after 8 hours of sleep and feel like any energy I had was just slipping right out of me. I would fall asleep on the floor in our play room when I was supposed to be playing barbies or a board game. So that just was obviously not good. So back to the doctor.
- Wellbutrin (Bupropion) an antidepressant used to treat major depressive disorder, seasonal affective disorder, a pharmacotherapy for smoking and has been known to help with attention and impulse control in certain patient populations (Acheson, deWit) https://www.ncbi.nlm.nih.gov/pubmed/18489015
I was told that it would help with the sleepiness and it did it was like night and day. I finally felt like a function person again and I felt like the combination of Strattera and Wellbutrin were working well together. I still had this nagging feeling that I was missing out on something if I didn’t at least try a stimulant. I knew the Strattera was working but there are potential liver issues. My doctor was very careful to add in extra liver panel’s in my blood work at my yearly wellness exam to make sure my liver wasn’t being damaged. Then to back that up even more my Pharmacogenomic testing came back that I was a rapid metabolizer which explained why if I missed a pill one day or on the weekends, I would start to immediately tell a difference. Typically, they say it takes days for it to be completely out of your system, well not me. It took weeks even months to notice a real significant difference and only 1-2 days for it to feel like it was going away.
- Vyvanse (lisdexamfetamine dimesylate) a central nervous system stimulant treatment for ADHD which is also used for binge eating disorder. It was the first stimulant I tried as I waited for my genetic test results. Something to note is that if you are on an MAOI inhibitor or have used one within 2 weeks it says DO NOT use Vyvanse. I asked to try this one because I had seen so many people in the support groups were having good results and it was supposed to last 8-10 hours. I noticed immediately the difference in the focus I had at work. It was wonderful, I was getting things done marking them off my checklist. I was replying to e-mails instead of ‘getting to them later’ I was calling people back. It really was amazing for me. The only problem was I felt like it was wearing off on the way home and by the time I got home I felt like I was crashing. I was anxious and irritable, snapping at my family not being able to be around them when all they wanted was to say hi because they hadn’t seen me all day. My kids wanted to tell me about their day and it was just too much to go from traffic to house with excited kids to cooking with a tv and talking in the background it was full on sensory overload. My doctor also took me off the Wellbutrin which now looking back I wonder if it would have helped with the crash had I stayed on it, I may just ask my doctor about that. I think if I remember right, I started on 20mg to make sure I didn’t have any bad side effects and went up to 30mg which is the most common starting ground. As much as I was loving the Vyvanse during the day I was taking it at 10am and by 6pm it was well gone and I was crashing. For me that doesn’t work I need 10 hours between work and home.
- Adderall XR (amphetamine and dextroamphetamine mixed salts) this is a combination of 2 stimulants. It is used to treat ADHD and narcolepsy. I noticed Adderall seemed to have a lot of drug interactions so check your medications against the list of interactions and with your doctor just to be safe. I think this is where I had already received my test results back and found out about Strattera, that SSRI’s (antidepressant medications) don’t work on me for the same reason as Strattera. The test did reveal that Methylphenidate had the highest probability of success but also the highest risk of adverse side effects. Taking that information into consideration we landed at Adderall. When I was on Adderall was the first time I really heard mention of the term Authorized Generic and why this term was so important but we will come back to that in a bit I promise…after all that is what this entire episode is about. I tried a few different dosages of the Adderall and added the Wellbutrin back into the mix. Well I am not sure if it just didn’t work or if it made things worse. I felt like I was in a tail spin and couldn’t do anything. At work I couldn’t focus or motivate myself to do anything. It was so bad I couldn’t imagine how there were people that this worked for. I couldn’t remember what things were like before the Strattera at this point because it had been almost 2years but I didn’t think it was as bad as they seemed on the Adderall. I think I made it 2 months on Adderall. I tried 2 different doses and that was it I was done I couldn’t keep functioning like that after knowing how much I could do with something that did work like Vyvanse and even Strattera.
- Concerta (Methylphenidate HCL, aka Ritalin, Methylin, Metadate etc.) used to treat the same as Adderall and in the same way. I was leery at this point it’s 2 years and nothing is really what I want it to be. I was ready to just say screw it and go back to Strattera despite the potential liver problems at the high doses I would need to take for it to be effective. I was also scared because what if this was ‘the one’ but I had really bad side effects like the DNA report said I could potentially experience? The one that scared me most was vomiting I HATE vomiting then there was potential vision problems….I really didn’t want that, most of the other common side effects I felt like I either already experienced them or wasn’t too worried. I talked it out with my doctor and despite my crazy ramblings she has not fired me as a patient and in fat is very patient and understanding I can’t tell you guys enough how lucky I am to have my doctor. I ultimately decided that I would try it and if I noticed anything wonky I would just stop immediately and we would try something else. Well the first month I took it I was given a generic. Ok I already knew a little about Authorized Generics vs generics but this is when I really started figuring things out. Again though this story is for a little bit later….not much longer I promise. I waited week by week and didn’t really notice anything no side effects but no improvement either. The next month I got the authorized generic and it was night and day. However, the third month which is right now I was put on a different generic but it still appears to be working. The only thing I have really noticed is the binge eating is back, and I am exhausted again. I will be discussing this with my doctor to see what we can do. I have been content but recently experiencing some severe depression and anxiety symptoms. Sorry guys you can tune out for a minute but this next bit concerns lady stuff. As a woman this could be due to fluctuations in hormones I noticed that a week before my last period I was so down and hormonal, my anxiety has been getting me worked up more than normal and my binge eating has been back with a vengeance. Again this could be because of the Wellbutrin maybe I need to adjust my dose or the Concerta since worsening mental health issues including depression can be a side effect, or it could just be normal monthly hormone fluctuations…although I haven’t noticed this previously but again I am not on the authorized generic anymore.
OK now that everyone is all caught up let’s get to the good stuff…you know the hints I dropped here and there about Authorized Generic Vs Generic the title of the episode too. I am going to give you fair warning that what follows may bore you to tears with scientific blah blah blah but I promise you will want to listen. Most of the information I am going to give you can be applied to any medication not just ADHD medications. All medications that have generics any way. What may surprise you the most to learn is that many of the medical professionals that I have had to deal with didn’t know or understand what the difference was and I was informing, nurses, pharmacy staff, and even a pharmacist what an Authorized Generic is. Yes, I know get on with it already I hear ya so lets start with the definition. I will probably have several of these. I promise this is the one episode that I am most excited to get out because I really hope it helps you avoid a lot of the frustrations I had to deal with and am still dealing with.
Authorized Generic as described by the FDA: https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs
“An approved brand name drug that is marketed without the brand name on its label. Other than the fact that it does not have the brand name on its label, it is the exact same drug product as the branded product. An authorized generic may be marketed by the brand name drug company, or another company with the brand company’s permission. In some cases, even though it is the same as the brand name product, a company may choose to sell the authorized generic at a lower cost than the brand name drug.”
From the FDA website above
A generic is a copy of a brand-name drug developed and made by another company that does NOT make the name brand. What does this mean? The active ingredient is the same, conditions that it treats are the same, dosage form (pill, capsule, tablet, syrup, etc.) are the same, also the strength, route of administration and parts of the labeling are the same. If everything’s the same then what’s the difference you ask? Excellent question! The inactive ingredients and sometimes even the delivery system or the way the medicine is released from the pill/capsule etc into your system like is the case with Concerta can be different.
That was a lot so I am going to leave it here so as not to overwhelm or bore you too much. In the next episode I want to really get into how the differences between authorized generics and generics can change how the medication works for you. Some there isn’t much difference, others it makes all the difference. Many people will tell you this is especially the case with Adderall and Concerta and I agree from personal experience.
Episode 16: Authorized Generics VS Generics Part Deux
Overall Most helpful site
Let’s just get into it. Don’t worry about writing anything down I am going to give you all the links you could ever want and the steps you need in the show notes so just take it all in.
PSA: Just like the last episode I want to make this disclaimer very clear before I go any further with this episode. I am NOT a medical professional of any kind nor do I play one on TV, I am not promoting any of the medications I have taken nor would I suggest that any of the ones I have tried are the “best” ADHD medication for anyone. A medication may be best for ME but I am one person with my own individual set of DNA and medical history that my doctor and I have referred to before making any decisions to try any of the medications I talk about. You have to speak with your doctor and take into account any medications you are currently on and your medical history before taking ANY new medication not just ADHD meds. I would also like to suggest carefully reading the possible side effects and look for any contraindications with your current medications, In medicine, contraindications means a factor that serves as a reason to withhold a certain medical treatment due to the harm that it would cause the patient. Like when you see commercials that say do not take if you are on an MAOI or not to take medication with certain supplements it’s the same type of thing. The more you know…..
Now that that is out of the way quick recap of the last episode. I rehashed the list of medications, side effects etc. I have tried to date. We also go into the definition and differences between an authorized generic vs generic. Just in case you don’t remember or didn’t listen in which case you really should. An authorized generic is when the brand company licenses another manufacturer or distributor the right to sell their brand product as a generic. That’s right an Authorized generic is the brand name medication in sheep’s clothing. Sneaky huh?? A generic on the other hand is a medication that has the same active ingredients, may have different inactive ingredients, but is bioequivalent to the brand meaning that it does essentially the same thing but may be slightly less effective or cause increased or differing side effects or in the case of Concerta have a completely different delivery system. Essentially a generic is a copy of the brand developed by another company so think of it like trying to recreate a recipe. You know what the main ingredients are but not sure exactly how much of each to use or what kind. The meal is pretty much the same but may taste slightly different. Say you are making a supreme pizza for example, you have your main ingredients dough, cheese, sauce, pepperoni, sausage, peppers, and onions. Let’s say the brand uses a special 4 cheese blend, they butter their crust and get it slightly cooked before adding their toppings and use yellow onions. These are all things you can’t really tell by looking at it. You go to make your supreme pizza and you use mozzarella cheese, white onions, and don’t bake your crust or butter it before adding the toppings to finish baking. They are both still supreme pizzas with the same primary ingredients. There are only slight differences but differences that can change the taste of the pizza all the same.
Ok so something I have been noticing while researching for this episode is that there are many misleading articles out there about the differences between generics and brand name drugs such as this one I found on the GoodRx site https://www.goodrx.com/blog/brand-vs-generic-drugs-whats-the-difference/ called Brand Vs Generic what’s the difference it states they are the same even the FDA website states they are the same then says bioequivalent on a different page. So what does that mean? Ok so bioequivalent is defined in 21 CFR (Code of Federal Regulations) § 320.1 as “The absence of a significant difference in the rate and extent to which the active ingredient or active moiety (In pharmacology, an active moiety is the portion of an ion or molecule responsible for the activity of a drug) in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.” Basically all the important things are the same/similar without there being a significant difference. The difference is 20% or less.
Adderall- I mentioned this before but when I was first prescribed Adderall I also had my first introduction to the whole Auth Generic VS Generic thing. I was told that I needed to request the manufacturer Prasco, Amerigen, or Sandoz to get the Authorized Generic of Adderall. This was because 1.) my insurance didn’t cover the name brand and 2.) because I had read that people had better luck with Adderall if it was the Brand or Authorized Generic vs the generic. What is happening is that more and more companies are creating their own generic versions most recently Teva and Impax have created their own generic versions of Adderall. So who knows what will happen with the availability of Authorized generics in the future.
FDA Listing of Auth Generics as of 12/2019
Now to the most important one and the one that seems to cause people the most issues, Concerta- chances are that you have been given a generic like I was. My first bottle of generic Concerta was from Mallinckrodt Pharmaceuticals. I didn’t think anything of it cause generics right, they are pretty much the same thing….WRONG I obviously didn’t learn anything from when I tried Adderall mostly because it didn’t work for me either way so for me there wasn’t a lesson learned and I forgot about it. What I came to find out after remembering what little I had learned from Adderall though is to pay attention. I also remembered the various complaints I had seen on the different FB groups about Concerta and issues with the generics not working. For Concerta this is particularly important because part of what works with Concerta is their delivery system. This is how the pill is manufactured to let the medication into your system slowly over time. This is what makes Concerta so unique from its generics. Concerta’s delivery is unique because of their patented OROS or osmotic-release oral system. The Alza corporation patented the OROS technology that is used to make Concerta an extended release product. This means no one else can make the same delivery system. Alza merged with Johnson and Johnson in 2001 which if you remember from last episode they also own Janssen. This is just a little background to explain why the pill says Alza on it and why it is the only one like it. The Concerta OROS is composed of 3 parts, there is the outer layer that is designed to give an immediate release dose into the system followed by a second drug layer that is released into the system by what they call the push layer made of a polymer that expands from the fluids in your system as it expands the pressure pushes the medication out at a controlled rate over the next 6-7 hours. What do the other generics do then? Well they are all different. Since the patent for this delivery system does not expire until July 2024, they can’t copy it just try to come close. Some use a bead system to achieve the extended release others drill laser holes in the top. There are a few others still but the thing is they are none of them the same. They are all attempting to do the same thing as Concerta’s OROS but aren’t quite there.
Another important thing to note is that some people think the FDA rating of AB means it is an Auhorized Generic this was a discussion I had on a FB group with a pharmacist. I had to explain that the rating just meant it was bioequivalent which still allows for that 20% variance I told you about. One generic manufacturer to be aware of is Mallinckrodt (the one I mentioned earlier that I tired first) and Kudco (now UCB/Kremers Urban) – the FDA changed their Orange Book therapeutic equivalence codes from AB (indicating therapeutic equivalence) to BX (data are insufficient to determine therapeutic equivalence). It is also noted that these should not be automatically substituted for the brand if the insurance will not cover it. This to me is pretty significant. So please check your bottle if you are just starting to take a generic for Concerta on your own ADHD rollercoaster and it doesn’t seem to be working this could be why so check your bottle and if it is from Mallinckrodt request a different manufacturer when you go for a refill. I am currently taking a generic from Alvogen that seems to work. The current company that sells the Authorized Generic is Patriot Pharmaceuticals, a subsidiary of the Brand company Janssen Pharmaceuticals which is owned by Johnson and Johnson.
As if all of this isn’t complicated enough, the process of just getting the Authorized generic was extremely painful. The following steps are the ones I had to go through and the whole process took me about a week due to the weekend, waiting for the doctor to change the pharmacy where the Rx was originally sent, waiting for prior approval, etc. These are in a sort of order but not really just make sure you have done everything. Gina Pera from ADHD Rollercoaster has amazing info that she updates i will have the link along with all of the others in the show notes by Wednesday.
- Make sure your doctor checks the no substitutions box on the Rx and writes it to ‘fill as directed’. This is important because then you will be more likely to get what you need from the insurance company and your pharmacy.
- Check with your Insurance to make sure that it will cover the generic you are trying to get. You would be surprised but it has actually happened where an insurance company will only cover the brand and not the generic where it is usually the opposite. There are also times where some generics are covered and others are not.
- Get the NDC or National Drug Code number. This is the number the pharmacist will use to request the authorization/prior authorization from your insurance company. It is what will be approved and what the Pharmacy will fill. What you will need to do to get this number is go to the FDA’s website. It’s easiest to just google NDC number you will find it or the link is in the show notes along with a dozen other links you might find useful. You can look it up by the proprietary name in this case Concerta and it will pull the codes for the Brand and any generics. You will need to know either the generic or non-proprietary name for Concerta that is Methylphenidate hydrochloride or the labeler so Patriot because that is who sells the Authorized Generic. You will also need to know what your dosage is or how many mg is it, 18, 27, 36, etc. This will help you narrow down which NDC you want. For 36mg dose your NDC number is 10147-0688-1.
- Call your pharmacy first to see if they carry the manufacturer they prefer if you have the NDC number it makes it easier for them to look up the drug in their system and tell you whether or not they have a contract with that company to sell the drug, have it in stock, or can/cannot order it. Having this number will make things so much quicker than them having to look it up by name, trust me I have done both. What you will do is call the pharmacy and ask if they carry that NDC number and if so then they need to request approval from your insurance company. I am not sure if they all work the same but I did run into the situation that my Rx had been written for a generic but it had been requested and approved on a specific NDC the pharmacy sent in so when I asked for the authorized generic NDC I had to get a whole new approval. It is important to make sure you know the pharmacy carries the authorized generic before getting the Rx filled. Don’t forget to make sure the pharmacy is requesting the correct NDC for approval from your insurance. I had to get a second prior approval because I had not done this and it was a pain and meant not only did I have to go the weekend without my medication but 2 working days as well while I waited for the authorization to come in.
- Once all of this is done and you are ready to pick up your Rx CHECK THE BOTTLE make sure it is what you requested as in the Authorized Generic. Read the label if you aren’t sure and can’t tell by the label ask because once you pay and leave it’s too late. This is how I discovered that after the first month of taking the authorized generic I worked so hard to get the pharmacy no longer has a contract with the manufacturer and can no longer get the authorized generic. Apparently companies renegotiate their contracts yearly around December. Ask the pharmacy when they renegotiate so you know and mark your calendar to make sure your authorized generic isnt’ swapped out for a generic. Guess what that means? Yep you have to start calling again. Did I mention I HATE this whole process? Why is this so hard? Never in my life have I had so much trouble getting medication.
- You may have to call multiple pharmacies to find one that does carry the Authorized Generic and it may not be the one you put on your drug contract with your doctor. Explain all of this to your doctor so they understand why you are requesting to switch pharmacies. I had to explain to a lot of people that there was in fact a difference between a generic and an authorized generic. Once I did the nurses, pharmacists, and my doctor understood more about why I was being such a pain in the but and many of them even thanked me for telling them something they didn’t know. You also have to worry about the company that currently holds the liscense to sell the authorized generic not having it or deciding to make there own generic then you really have to start over.
- How to find the authorized generic
- Therapeutic equivalency does not = authorized generic it is just how close the generic is to the brand and as such the authorized generic.
- Requesting the doctor writes the Rx so you can get the generic
- Checking with insurance to make sure the medication is covered just because it is a generic doesn’t mean it is covered.
- Calling the pharmacy and requesting the authorized generic by the NDC number and how to find the NDC number
- finding the manufacturer/distributor of the Authorized generic and what pharmacies they sell too
- checking the bottle before you pay for and take home your Rx to verify the manufacturer is the one who sells the Authorized generic you requested
- Pharmacies renegotiate contracts Dec/Jan so just because you found a pharmacy that sells the Authorized Generic it may change so make checking the label before you pay and take home a habit. This happened to me with the Concerta.
https://www.fda.gov/media/71474/download Therapeutic Equivalencies rating information