ADD Forums - Attention Deficit Hyperactivity Disorder Support and Information Resources Community  

Go Back   ADD Forums - Attention Deficit Hyperactivity Disorder Support and Information Resources Community > TREATMENT & MANAGEMENT > Medications > Adderall
Register Blogs FAQ Chat Members List Calendar Donate Gallery Arcade Mark Forums Read

Adderall (four amphetamine salts)

Reply
 
Thread Tools Display Modes
  #1  
Old 05-24-12, 01:39 AM
Dubwise's Avatar
Dubwise Dubwise is offline
ADDvanced Member
 

Join Date: Jan 2012
Location: Alexandria, Virginia
Posts: 114
Thanks: 50
Thanked 60 Times in 35 Posts
Dubwise is on a distinguished road
I think I may have solved the great GENERIC ADDERALL DEBATE!

I had posted this in response to another posters question, but I feel my findings are important enough to warrant their own thread to encourage more discussion. Below is a combination of several posts I made in a different thread. I feel more people will see them here as they are not associated with a very specific question about barr/teva.

----

The FDA does allow a small percentage of variance in amount of active ingredient. I do know for certain there are no regulations on the inactive ingredients. To be clear the "inactive ingredients" still could have affects on the performance of the drug in some people, but in general if the FDA approves a generic it works as close to the name brand drug as possible in the majority of people taking it.

The FDA does not seem to actually have a set standard of allowance of any discrepancy that I can find in research on this topic today, however studies have been done comparing the absorption of generics vs name brand drugs and have identified a 3.5% fluctuation in the absorption between them. [SOURCE: Davit et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother. 2009;43(10):1583-97.]

Below are some info I found searching the FDA website:

Quote:
Originally Posted by fda FAQ
What standards do generic drugs have to meet?
Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:
  • contain the same active ingredients as the innovator drug(inactive ingredients may vary)
  • be identical in strength, dosage form, and route of administration
  • have the same use indications
  • be bioequivalent
  • meet the same batch requirements for identity, strength, purity, and quality
  • be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products SOURCE


Quote:
Originally Posted by FDA Generic Drug standards Facts
FACT: FDA requires generic drugs to have the same quality and performance as brand name drugs.
  • When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity, and potency. However, some variability can and does occur during manufacturing, for both brand name and generic drugs. When a drug, generic or brand name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.
  • Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product. Generic drugs do not need to contain the same inactive ingredients as the brand name product.
  • The generic drug manufacturer must prove its drug is the same as (bioequivalent) the brand name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured. If the levels of the drug in the bloodstream are the same as the levels found when the brand name product is used, the generic drug will work the same.
  • Through review of bioequivalence data, FDA ensures that the generic product performs the same as its respective brand name product. This standard applies to all generic drugs, whether immediate or controlled release.
  • All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs, and the generic products must meet the same exacting specifications as any brand name product. In fact, many generic drugs are made in the same manufacturing plants as brand name drug products.
SOURCE


Another point I feel is important to bring up is that a medication that does not carry a trade name such as 'Amphetamine salts' not identified as a generic to adderall (not saying this applies specifically just using as an example) is not the same as a generic for a trade named medication. The addition or omission of certain inactive ingredients can and does affect the performance of a drug and can prevent it from performing as well as the trade named drug(such as adderall). There are regulations ensuring a drug claiming to be a generic of adderall behaves like adderall. There are no regulations that a drug not claiming to be a generic works as well as the trade named drug with similar active ingredients.

I feel this is important becuase there are a lot of Amphetamine salt drugs that ADHD patients receive, I think that we need to do additional research to see if these are all listed as official generics of adderall. This could be difficult becuase the document I quoted below indicates that drugs are sometimes mislabled as generics in databases so that insurance will pick up the cost under the coverage of generics. See Below:

Quote:
Originally Posted by source PDF
The absence of a trade name does not equal a generic drug
Not all drugs marketed with out a trade name are approved generics. For example the drug product albuterol sulfate HFA, manufactured by IVAX, was approved without a proprietary name on Oct. 29, 2004, under NDA 21-457. Since the IVAX albuterol sulfate HFA product is labeled with only the established (generic) name, one could easily assume this is a generic version of one of the other two currently marketed albuterol sulfate HFA products: Proventil HFAand Ventolin HFA. Although all three products contain the same active ingredient and propellant (HFA), they are not substitutable products. Differences in excipients such as oleic acid and alcohol—in addition to actual differences in device components, such as the canister and size of valve—may affect performance, resulting in different clinical responses.

Confusion may also arise when drug products are listed incorrectly in drug databases. For example, First Data Bank and Medispan list IVAX albuterol sulfate HFAas a generic drug. Additionally, in clinical practice various
formularies may consider all three brand-name products as generics for reimbursement purposes. SOURCE



There is an FDA resource that maintains lists of all approved generic drugs and call it 'the orange book' and can tell us if various tablets sold as 'amphetamine salts' are approved generics to adderall. Below are my findings when searching for FDA approved generics to adderall:

Quote:
Originally Posted by orange book

Searched for Adderall
N021303
RLD:No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL 2.5MG;2.5MG;2.5MG;2.5MG ADDERALL XR 10 SHIRE

N021303
RLD:No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL 3.75MG;3.75MG;3.75MG;3.75MG ADDERALL XR 15 SHIRE

N021303
RLD:No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL 5MG;5MG;5MG;5MG ADDERALL XR 20 SHIRE

N021303
RLD:No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL 6.25MG;6.25MG;6.25MG;6.25MG ADDERALL XR 25 SHIRE

N021303
RLD:Yes AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL 7.5MG;7.5MG;7.5MG;7.5MG ADDERALL XR 30 SHIRE

N021303
RLD:No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL 1.25MG;1.25MG;1.25MG;1.25MG ADDERALL XR 5 SHIRE
Searched for Medications containing Amphetamine salts
A040422 RLD:
Yes AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 7.5MG;7.5MG;7.5MG;7.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR

A040422 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 1.25MG;1.25MG;1.25MG;1.25MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR
A040422 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 1.875MG;1.875MG;1.875MG;1.875MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR
A040422 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 2.5MG;2.5MG;2.5MG;2.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR
A040422 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 3.125MG;3.125MG;3.125MG;3.125MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR
A040422 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 3.75MG;3.75MG;3.75MG;3.75MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR
A040422 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 5MG;5MG;5MG;5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR
A040444 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 1.25MG;1.25MG;1.25MG;1.25MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE COREPHARMA
A040444 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 2.5MG;2.5MG;2.5MG;2.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE COREPHARMA
A040444 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 5MG;5MG;5MG;5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE COREPHARMA
A040444 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 7.5MG;7.5MG;7.5MG;7.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE COREPHARMA
A040439 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 1.25MG;1.25MG;1.25MG;1.25MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE SANDOZ
A040439 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 2.5MG;2.5MG;2.5MG;2.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE SANDOZ
A040439 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 5MG;5MG;5MG;5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE SANDOZ
A040439 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 7.5MG;7.5MG;7.5MG;7.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE SANDOZ
A040472 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 1.25MG;1.25MG;1.25MG;1.25MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TEVA PHARMS
A040472 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 2.5MG;2.5MG;2.5MG;2.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TEVA PHARMS
A040472 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 5MG;5MG;5MG;5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TEVA PHARMS
A040472 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 7.5MG;7.5MG;7.5MG;7.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TEVA PHARMS


I bolded the RLD(Reference Listed Drug) in the above examples because this seems very important. The definition of this is in quotes below. This would seem to indicate that only one of the above listed results is actually a recognized Generic of adderall and all others in the list are all brand name since they lack an RLD. All other drugs containing a mix of amphetamine salts that are not listed are not FDA Approved as actual generics for adderall and are being sold as 'amphetamine salts' and are not necessarily equivalent to adderall in its absorption and effectiveness. This seems to indicate that ONLY BARR produced 'amphetamine salts' is approved to be called ADDERALL GENERIC. This could finally explain why there is so much debate surrounding which manufacturers 'generic' is the closest to name brand adderall. I may be interpreting this wrong so by all means if anyone can weigh in on this I think it will help the discussion.

Quote:
Originally Posted by RLD
A reference listed drug (21 CFR 314.94(a)(3)) means the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its ANDA(generic drug labeling).
FDA has identified in the Prescription Drug Product and OTC Drug Product Lists those reference listed drugs to which the in vivo bioequivalence (reference standard) and, in some instances, the in vitro bioequivalence of the applicant's product is compared. By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. Such variations could result if generic drugs were compared to different reference listed drugs. However, in some instances when listed drugs are approved for a single drug product, a product not designated as the reference listed drug and not shown to be bioequivalent to the reference listed drug may be shielded from generic competition. A firm wishing to market a generic version of a listed drug that is not designated as the reference listed drug may petition the Agency through the Citizen Petition procedure (see 21 CFR 10.25(a) and CFR 10.30). When the Citizen Petition is approved, the second listed drug will be designated as an additional reference listed drug and the petitioner may submit an Abbreviated New Drug Application citing the designated reference listed drug. Therapeutic Equivalence Evaluations Codes Products meeting necessary bioequivalence requirements explains the AB, AB1, AB2, AB3coding system for multisource drug products listed under the same heading with two reference listed drugs.


TL;DR = ONLY BARR is producing approved generics for branded adderall.

Additionally there is a WEALTH of information regarding generic drugs on the FDA site below:

http://www.fda.gov/Drugs/ResourcesFo.../ucm169209.htm
__________________
Like Electro house, tech house, breaks and drum&bass? Come check out my mixes:
http://www.mixcloud.com/ChristoFarley/

Last edited by Dubwise; 05-24-12 at 02:06 AM..
Reply With Quote
The Following 13 Users Say Thank You to Dubwise For This Useful Post:
AddYourAll (05-24-12), Amtram (05-24-12), BillDoolin (06-07-12), Drewbacca (05-28-12), Jay Dee 23 (10-27-17), Jenn1202 (10-22-14), kali_shey (05-30-12), Maurice (10-20-14), salleh (05-24-12), sarahsweets (05-24-12), TeamKProd. (05-30-12), upworkhometvbed (06-11-13), Waitingame (08-16-16)
  #2  
Old 05-24-12, 09:37 AM
JR1973 JR1973 is offline
ADDvanced Forum Guru
 

Join Date: Oct 2006
Location: USA
Posts: 1,210
Thanks: 1
Thanked 298 Times in 214 Posts
JR1973 is a jewel in the roughJR1973 is a jewel in the roughJR1973 is a jewel in the rough
Re: I think I may have solved the great GENERIC ADDERALL DEBATE!

Howdy fellow Alexandria, VA resident!

Dang, you've done your homework. Thanks for sharing this info.
Reply With Quote
The Following User Says Thank You to JR1973 For This Useful Post:
Dubwise (05-29-12)
  #3  
Old 05-24-12, 11:08 AM
sbcy sbcy is offline
Contributor
 

Join Date: Mar 2011
Location: Chicago, IL
Posts: 482
Thanks: 3
Thanked 119 Times in 79 Posts
sbcy is a jewel in the roughsbcy is a jewel in the roughsbcy is a jewel in the rough
Re: I think I may have solved the great GENERIC ADDERALL DEBATE!

Quote:
TL;DR = ONLY BARR is producing approved generics for branded adderall.
Not quite, Barr seems to be what other generics of Adderall IR are now based on (since Shire no longer makes it). Thanks for the interesting post.

"RLD (Reference Listed Drug)*
A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA).* By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart."

Haha what a joke, come on FDA peeps.

http://www.fda.gov/Drugs/information...079436.htm#RLD

Does anyone know why drug companies always seem to make their RLD the highest strength of a medication?
__________________
PLEASE Boycott: Teva/Barr, CorePharma, Mallinckrodt (Methylin)
Diagnoses: ADD-PI, GAD, OCD (mild)
Reply With Quote
The Following 2 Users Say Thank You to sbcy For This Useful Post:
Amtram (05-24-12), Drewbacca (05-28-12)
Sponsored Links
  #4  
Old 05-24-12, 02:01 PM
AronP24 AronP24 is offline
Member
 

Join Date: May 2011
Location: Jawja
Posts: 30
Thanks: 2
Thanked 6 Times in 5 Posts
AronP24 is on a distinguished road
Re: I think I may have solved the great GENERIC ADDERALL DEBATE!

This has been known for a while and even posted in previous years..but yes, it is phenomenal information to have and should show everyone that Sandoz is the only one close to the original Adderall formula...Barr is garbage filled with horrible fillers
Reply With Quote
  #5  
Old 05-24-12, 06:20 PM
Dubwise's Avatar
Dubwise Dubwise is offline
ADDvanced Member
 

Join Date: Jan 2012
Location: Alexandria, Virginia
Posts: 114
Thanks: 50
Thanked 60 Times in 35 Posts
Dubwise is on a distinguished road
Re: I think I may have solved the great GENERIC ADDERALL DEBATE!

Quote:
Originally Posted by AronP24 View Post
This has been known for a while and even posted in previous years..but yes, it is phenomenal information to have and should show everyone that Sandoz is the only one close to the original Adderall formula...Barr is garbage filled with horrible fillers
I am not sure how you deduced that from the information provided, it seems you did not read the information and assumed that it contained something you have read previously. The listings for sandoz do not have a reference listed drug to compare to. This means they are being produced solely as an amphetamine salt and not a generic of the original branded Adderall. While it may work better for people in some cases, it is not close enough to the documented absorption and effectiveness of Adderall to be an OFFICIAL called generic for Adderall.

Shire is listing multiple XR drugs as trade name adderall and then one XR generic drug that references adderall. This means that there is one 'official' generic XR Adderall and it is also made by shire.

As far as IR is concerned, there was no IR drug listed with the trade name Adderall meaning it is only available in generic. Only Barr is listing an RLD for their 'amphetamine salts' combo meaning it is the only OFFICIAL IR generic to Adderall. All other manufacturers are producing a basic amphetamine salts prescription drug that does not have the same absorption or effectiveness as original branded Adderall, this includes corepharma, sandoz and teva(who incidentally is owned by barr).

While Barr may contain 'horrible fillers' as stated by many posters on these forums and the internet in general, it is the only one with FDA approved efficiency and absorption levels in comparison to trade name Adderall.

As the information points out, many drugs are unofficially listed as generics to Adderall to meet the requirements of insurance companies who cover generic drugs. This does not make them approved generic versions of trade name Adderall though because they still lack the qualities such as comparable absorption and effectiveness required to be called an approved generic.

None of this means that Barr is the best version of amphetamine salts combo. All this means is that Barr is the most similar in action to the original Adderall formula, it is the one that is most like the version that patents were originally taken out against. That is not to say that some people will find other brands better.

The only thing this information points out is the reason why there is so much reported difference in effectiveness from brand to brand and why there is a paradoxical report from doctors and pharmacists that all generics are the same. Doctors and pharamcists beleive that there is no difference because the FDA says there can't be in order for the pills to be called Generic adderall. But patients believe there is a difference because manufactures who are not approved as generics are being referred to them as such so that insurance will cover them. Essentially all this confusion and debate between patients and doctors comes down to a semantics issue.
__________________
Like Electro house, tech house, breaks and drum&bass? Come check out my mixes:
http://www.mixcloud.com/ChristoFarley/

Last edited by Dubwise; 05-24-12 at 06:32 PM..
Reply With Quote
The Following User Says Thank You to Dubwise For This Useful Post:
Drewbacca (05-28-12)
  #6  
Old 05-25-12, 01:41 AM
sbcy sbcy is offline
Contributor
 

Join Date: Mar 2011
Location: Chicago, IL
Posts: 482
Thanks: 3
Thanked 119 Times in 79 Posts
sbcy is a jewel in the roughsbcy is a jewel in the roughsbcy is a jewel in the rough
Re: I think I may have solved the great GENERIC ADDERALL DEBATE!

Quote:
Originally Posted by Dubwise View Post
As the information points out, many drugs are unofficially listed as generics to Adderall to meet the requirements of insurance companies who cover generic drugs. This does not make them approved generic versions of trade name Adderall though because they still lack the qualities such as comparable absorption and effectiveness required to be called an approved generic.

None of this means that Barr is the best version of amphetamine salts combo. All this means is that Barr is the most similar in action to the original Adderall formula, it is the one that is most like the version that patents were originally taken out against. That is not to say that some people will find other brands better.

The only thing this information points out is the reason why there is so much reported difference in effectiveness from brand to brand and why there is a paradoxical report from doctors and pharmacists that all generics are the same. Doctors and pharamcists beleive that there is no difference because the FDA says there can't be in order for the pills to be called Generic adderall. But patients believe there is a difference because manufactures who are not approved as generics are being referred to them as such so that insurance will cover them. Essentially all this confusion and debate between patients and doctors comes down to a semantics issue.
Again, this doesn't seem to be accurate, RLD drugs are the ones new generic drugs are based on. Just because a drug isn't a RLD doesn't mean it's not a generic of a specific drug. It just means that other manufacturers don't base their formulations off that drug. In short, Barr is now the master copy now. But that doesn't prove how far off Barr's formulation is from Shire's? It's possible that some of the current manufacturers are "off" from Barr's current formulation and end up being closer to Shire's original than Barr. There's simply no way of telling which is closer to a formulation we no longer have access to, not to mention a lab (and considerable knowledge of chemistry) to perform the accurate tests. It would be interesting if someone with sufficient knowledge and skill could compare brand name brand XR (since that's all that's left of brand Adderall) to the current IR on a chemical level if the time release mechanism could some how be removed. Not sure on the science behind that, where are the chem grad students?
__________________
PLEASE Boycott: Teva/Barr, CorePharma, Mallinckrodt (Methylin)
Diagnoses: ADD-PI, GAD, OCD (mild)
Reply With Quote
The Following User Says Thank You to sbcy For This Useful Post:
Drewbacca (05-28-12)
  #7  
Old 05-25-12, 02:58 AM
Galactica75's Avatar
Galactica75 Galactica75 is offline
Member
 

Join Date: Aug 2011
Location: Caprica
Posts: 60
Thanks: 18
Thanked 18 Times in 14 Posts
Galactica75 is on a distinguished road
Re: I think I may have solved the great GENERIC ADDERALL DEBATE!

Quote:
Originally Posted by sbcy View Post
Again, this doesn't seem to be accurate, RLD drugs are the ones new generic drugs are based on. Just because a drug isn't a RLD doesn't mean it's not a generic of a specific drug. It just means that other manufacturers don't base their formulations off that drug. In short, Barr is now the master copy now. But that doesn't prove how far off Barr's formulation is from Shire's? It's possible that some of the current manufacturers are "off" from Barr's current formulation and end up being closer to Shire's original than Barr. There's simply no way of telling which is closer to a formulation we no longer have access to, not to mention a lab (and considerable knowledge of chemistry) to perform the accurate tests. It would be interesting if someone with sufficient knowledge and skill could compare brand name brand XR (since that's all that's left of brand Adderall) to the current IR on a chemical level if the time release mechanism could some how be removed. Not sure on the science behind that, where are the chem grad students?

Yes and after Duramed acquired Shire's adderall IR rights, they "updated" the formulation of the Aderall®IR tablets, before they got bought out by the Teva/barr cartel.
There were a lot of complaints on these forums when the Duramed adderall started rolling out. This being one of the more recent ones.

So RLD doesn't mean much given the business history of the adderall IR tablet manufacturers.
Reply With Quote
  #8  
Old 05-28-12, 12:27 PM
Dubwise's Avatar
Dubwise Dubwise is offline
ADDvanced Member
 

Join Date: Jan 2012
Location: Alexandria, Virginia
Posts: 114
Thanks: 50
Thanked 60 Times in 35 Posts
Dubwise is on a distinguished road
Re: I think I may have solved the great GENERIC ADDERALL DEBATE!

Quote:
Originally Posted by sbcy View Post
Again, this doesn't seem to be accurate, RLD drugs are the ones new generic drugs are based on. Just because a drug isn't a RLD doesn't mean it's not a generic of a specific drug. It just means that other manufacturers don't base their formulations off that drug. In short, Barr is now the master copy now. But that doesn't prove how far off Barr's formulation is from Shire's? It's possible that some of the current manufacturers are "off" from Barr's current formulation and end up being closer to Shire's original than Barr. There's simply no way of telling which is closer to a formulation we no longer have access to, not to mention a lab (and considerable knowledge of chemistry) to perform the accurate tests. It would be interesting if someone with sufficient knowledge and skill could compare brand name brand XR (since that's all that's left of brand Adderall) to the current IR on a chemical level if the time release mechanism could some how be removed. Not sure on the science behind that, where are the chem grad students?
I never claimed it proved anything about barr, except to say that it is the only one who's performance is based on and compared to another proginal drug. According to the documentation on the FDA site all other brands are first generation Amphetamine salt prescription drugs.

The aim of my research was to prove that all of the drugs DO IN FACT have varying degrees of affectiveness because they are not all based on a single drug and have comparable effects to a single drug. Rather than comparing apples (adderall) to carious other apples (various generics to adderall), we are comparing apples (adderall) to imatation apples (barr) to oroanges (corpharma) to pineaples (sandoz) etc.

I do not know that you will find any MORE accurate information. This is straight from the horses mouth. Straight from the people who approve, label and deny drugs that do not meet the criteria to be called a generic. You do not have to take my word for it, I posted all of my sources and links to them (where available), go read it for yourself.

The documentation definitively illustrates a few points:

1. There is currently one(1) company(Shire) producing both trade name(first generation) and generic(second generation) XR Adderall.

2. There are NO companies producing trade name(first generation) IR Adderall.

3. Only one company company(barr) producing generic(second generation) IR adderall.

4. There are multiple companies(corepharma, sandoz and teva) producing non-trade name/non generic(first generation) amphetamine salts.




Quote:
Originally Posted by Galactica75 View Post
...snip....

So RLD doesn't mean much given the business history of the adderall IR tablet manufacturers.
It does mean much, the point you guys seem to be completely missing is that: in order for a Trade Name drug (first generation) to have an FDA approved Generic(second generation), it must have an RLD listed. Other wise it is niether a Trade name (first gen) or a generic (2nd gen). It is classified as a no-name (first gen). A no name (first gen) has no requirement or expectation to act exactly like any other first gen or second gen drug. Or like any other no-name first gen for that matter.

The whole point of this was not to prove what generic was better, only to explain why there are such wildly different experiences of the different brands and why patients continue to report differences between amphetamine salts brands despite pharmacists and doctors claiming they are all the same. It seems that all this time docs and pharmacists have all been reporting the standards of first and second gen named drugs and patients are reviewing the first gen no-name drugs. This whole time they(professionals) have been using very specific terms(generic regulations) to describe very specific products(trade name first gen drugs and generic second gen drugs) while we have been using and reviewing a completely separate group of non-comparable products(first gen no-name drugs).


If you feel this information is inaccurate, by all means do your own research. Post it in response to my posts in this thread, show your work and cite your sources. Other wise it is just your unsubstantiated opinions.



TL;DR = 1 trade name Adderall XR, 1 Generic for Adderall and 3 no-name amphetamine salt combo drugs.




__________________
Like Electro house, tech house, breaks and drum&bass? Come check out my mixes:
http://www.mixcloud.com/ChristoFarley/

Last edited by Dubwise; 05-28-12 at 12:38 PM..
Reply With Quote
The Following User Says Thank You to Dubwise For This Useful Post:
Drewbacca (05-28-12)
  #9  
Old 05-28-12, 01:37 PM
Drewbacca's Avatar
Drewbacca Drewbacca is offline
ADDvanced Forum ADDvocate
 

Join Date: Apr 2012
Location: États-Unis
Posts: 4,231
Blog Entries: 5
Thanks: 6,776
Thanked 6,260 Times in 2,929 Posts
Drewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond repute
Re: I think I may have solved the great GENERIC ADDERALL DEBATE!

Thanks for the legwork Dubwise! I found a few additional links that may be helpful in supporting your conclusions.


Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products.
http://www.fda.gov/downloads/Drugs/G.../ucm070124.pdf


CFR - Code of Federal Regulations Title 21
PART 320 -- BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
http://www.accessdata.fda.gov/script....cfm?fr=320.24


Facts about Generic Drugs
http://www.fda.gov/drugs/resourcesfo.../ucm167991.htm

For the sake of objectivity, I found one article that is critical of FDA standards. I think that it would make a good starting point if anyone really wants to argue that generics just don't cut it.
http://articles.latimes.com/2008/mar...-genericside17
Reply With Quote
The Following User Says Thank You to Drewbacca For This Useful Post:
kali_shey (05-30-12)
  #10  
Old 05-28-12, 01:58 PM
Drewbacca's Avatar
Drewbacca Drewbacca is offline
ADDvanced Forum ADDvocate
 

Join Date: Apr 2012
Location: États-Unis
Posts: 4,231
Blog Entries: 5
Thanks: 6,776
Thanked 6,260 Times in 2,929 Posts
Drewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond repute
Re: I think I may have solved the great GENERIC ADDERALL DEBATE!

Quote:
Originally Posted by sbcy View Post
There's simply no way of telling which is closer to a formulation we no longer have access to, not to mention a lab (and considerable knowledge of chemistry) to perform the accurate tests. It would be interesting if someone with sufficient knowledge and skill could compare brand name brand XR (since that's all that's left of brand Adderall) to the current IR on a chemical level if the time release mechanism could some how be removed. Not sure on the science behind that, where are the chem grad students?
A simple test might be possible with a home drug test for amphetamines. The level of amphetamines in urine should give a reasonable comparison, although it won't tell us the level that has reached the blood. No need for a chem grad student, we should be able to come up with a method with a little elbow grease and the internet.
Reply With Quote
The Following User Says Thank You to Drewbacca For This Useful Post:
kali_shey (05-30-12)
  #11  
Old 05-28-12, 02:37 PM
spc123's Avatar
spc123 spc123 is offline
ADDvanced Member
 

Join Date: May 2012
Location: Canada
Posts: 136
Thanks: 37
Thanked 129 Times in 67 Posts
spc123 has a spectacular aura aboutspc123 has a spectacular aura about
Re: I think I may have solved the great GENERIC ADDERALL DEBATE!

There are only two things any reasonable person need know to come to a conclusion.

1) The law states generics must preform in a manner equivalent to name brand drugs.
2) The USA is full of lawyers who would absolutely love for pharmaceutical companies to violate the law so they can sue them for many, many millions of dollars.

Don't trust people to do what's right. Trust them to do what's in their best interests. Passing off a generic drug that differs significantly from its brand counterpart is simply not in big pharma's interest.
Reply With Quote
  #12  
Old 05-28-12, 06:53 PM
zoekate's Avatar
zoekate zoekate is offline
Member
 

Join Date: May 2012
Location: Australia
Posts: 61
Thanks: 79
Thanked 43 Times in 26 Posts
zoekate has a spectacular aura aboutzoekate has a spectacular aura about
Re: I think I may have solved the great GENERIC ADDERALL DEBATE!

Quote:
Originally Posted by spc123 View Post
Passing off a generic drug that differs significantly from its brand counterpart is simply not in big pharma's interest.
The point being made is that aside from one, 'generic amphetamine salt' drugs are NOT being called generic adderall in the most important document - the FDA listing.

This means that these drugs may legally have wider differences in active ingredients versus adderall than in comparison to a listed generic.
__________________
(\o/)
(/|\) Oh look! It's a butterfly!
Reply With Quote
The Following User Says Thank You to zoekate For This Useful Post:
Dubwise (05-29-12)
  #13  
Old 05-28-12, 07:53 PM
spc123's Avatar
spc123 spc123 is offline
ADDvanced Member
 

Join Date: May 2012
Location: Canada
Posts: 136
Thanks: 37
Thanked 129 Times in 67 Posts
spc123 has a spectacular aura aboutspc123 has a spectacular aura about
Re: I think I may have solved the great GENERIC ADDERALL DEBATE!

A drug that is not a recognized generic can not be substituted for a brand name drug. It would need to be prescribed specifically. There are a ton of manufacturers selling hydrocodone based drugs as well. If you doctor prescribes Vicodin, only a recognized generic can be substituted. Even in this case, you can still request the name brand.

The only time there might be some ambiguity is if the doctor writes the ingredient name and dosage, rather than the drug name, for example "mixed amphetamine salts, 20mg" rather than Adderall 20mg. Even in that case, the patient can still request whichever brand of drug they prefer.

One further thing: A drug can not be introduced to market without rigorous testing. The only exception to this is a drug released under an expired patent. Perhaps these aren't specifically listed as generics in the FDA database, I am no expert on FDA inner workings so I don't know. But these drugs have to have met the same guidelines as the patent they are following.

One note of related personal experience: I have in the past participated in forums where this topic has been discussed to such lengths that any new topics related to the question are answered by a moderator and immediately closed. There is no evidence to show significant variance between differing manufactures offering drugs at equivalent dosage. This has be confirmed by doctors, pharmacists and chemists. That said placebo is certainly a very real effect, and if you are worried that one brand doesn't work as well as another, you can always request a specific brand of medication, or a specific generic or non-generic manufacturer.
Reply With Quote
The Following 2 Users Say Thank You to spc123 For This Useful Post:
Drewbacca (05-28-12), Maurice (10-20-14)
  #14  
Old 05-28-12, 08:12 PM
LauraF915 LauraF915 is offline
Member
 

Join Date: May 2012
Location: Alexandria, VA
Posts: 28
Thanks: 9
Thanked 18 Times in 12 Posts
LauraF915 is on a distinguished road
Re: I think I may have solved the great GENERIC ADDERALL DEBATE!

Quote:
Originally Posted by spc123 View Post
One further thing: A drug can not be introduced to market without rigorous testing. The only exception to this is a drug released under an expired patent. Perhaps these aren't specifically listed as generics in the FDA database, I am no expert on FDA inner workings so I don't know. But these drugs have to have met the same guidelines as the patent they are following.
I have studied FDA regulatory law (and taken classes in law school on generic drugs), so while I'm not an expert on the inner workings of FDA, I do have some education on it. I also worked as a paralegal for 3 years at a law firm that specialized in FDA Regulatory Law (and I went back there my first summer as a law clerk).

I'm not sure exactly what you mean by "the only exception to this is a drug released under an expired patent." The only way for a "drug" to be released into the market place without extensive testing and FDA approval is if it is released as a dietary supplement (i.e. all the late night commercials for pills that will do all sorts of miraculous things that have a disclaimer in tiny print that says something to the effect of "These claims have not been reviewed or approved by the FDA.") If a company wants to release a drug (as opposed to a dietary supplement), it must undergo significant testing and a long process with FDA. (And yes, there are requirements for dietary supplements and no, you can't just claim your product is a dietary supplement when it's really a drug to get around the extensive testing)

If the drug is an innovator drug (i.e., a new compound), the company must submit a New Drug Application (NDA), which can take decades to get approved and costs $1.8M to have FDA review (hence why drugs are SO expensive while they are under patent).

If the drug is not novel (i.e., it's a 'generic'), and the patent and FDA granted exclusivity period for the innovator drug have both expired, then the company can submit an Abbreviated New Drug Application (ANDA) which is frequently called a "me too" application - because the company is saying "My drug is just like his drug, so you should approve me too." The review time and cost for ANDAs is much lower because all you have to do is demonstrate that your product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. So while you don't have to prove the safety of the drug all over again (which is required in the NDA), you have to prove that you're enough like the innovator drug to show you're safe.
Reply With Quote
The Following 3 Users Say Thank You to LauraF915 For This Useful Post:
Drewbacca (05-28-12), Dubwise (05-29-12), Maurice (10-20-14)
  #15  
Old 05-28-12, 08:39 PM
Drewbacca's Avatar
Drewbacca Drewbacca is offline
ADDvanced Forum ADDvocate
 

Join Date: Apr 2012
Location: États-Unis
Posts: 4,231
Blog Entries: 5
Thanks: 6,776
Thanked 6,260 Times in 2,929 Posts
Drewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond reputeDrewbacca has a reputation beyond repute
Re: I think I may have solved the great GENERIC ADDERALL DEBATE!

Quote:
Originally Posted by zoekate View Post
The point being made is that aside from one, 'generic amphetamine salt' drugs are NOT being called generic adderall in the most important document - the FDA listing.

This means that these drugs may legally have wider differences in active ingredients versus adderall than in comparison to a listed generic.
True, but I think it is important to clarify that we are talking about both XR and IR? If we just look at the XR, I'm confused about patent issues:
As far as the XR release, Shire(?) still owns a few patents that don't expire until 2016, so they may in fact be very different time-release mechanisms for the two different extended release products. My guess, is that the mixed salt formula expired in 2009, but not the release mechanism patents. In which case, generic XR "adderall" is a different drug despite the same active ingredients. I'm not sure if this is right, but that's how I'm understanding it.

It seems like the Orange book isn't giving a full listing? I'll have to research that one a bit more or talk to a pharmacist friend.


Quote:
Originally Posted by LauraF915 View Post
The only way for a "drug" to be released into the market place without extensive testing and FDA approval is if it is released as a dietary supplement (i.e. all the late night commercials for pills that will do all sorts of miraculous things that have a disclaimer in tiny print that says something to the effect of "These claims have not been reviewed or approved by the FDA.") If a company wants to release a drug (as opposed to a dietary supplement), it must undergo significant testing and a long process with FDA. (And yes, there are requirements for dietary supplements and no, you can't just claim your product is a dietary supplement when it's really a drug to get around the extensive testing)

If the drug is an innovator drug (i.e., a new compound), the company must submit a New Drug Application (NDA), which can take decades to get approved and costs $1.8M to have FDA review (hence why drugs are SO expensive while they are under patent).

If the drug is not novel (i.e., it's a 'generic'), and the patent and FDA granted exclusivity period for the innovator drug have both expired, then the company can submit an Abbreviated New Drug Application (ANDA) which is frequently called a "me too" application - because the company is saying "My drug is just like his drug, so you should approve me too." The review time and cost for ANDAs is much lower because all you have to do is demonstrate that your product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. So while you don't have to prove the safety of the drug all over again (which is required in the NDA), you have to prove that you're enough like the innovator drug to show you're safe.
My understanding is that having the label "dietary supplement" is more a correlation and not the basis of what the FDA controls? Generally speaking (ignoring things like THC), the FDA doesn't control plant derivatives such as vitamins and amino acids which may get labeled as a dietary supplement in certain mixes. I could be wrong, but all of the amphetamine-based weight loss products have been taken off market and would be under FDA OTC jurisdiction.

I think the different requirements for the NDA and the ANDA might be the problem, if any. Being able to show that the same amount of product ends up in the blood stream doesn't guarantee that a clinical test would give the expected results. From a cost point of view, it makes sense, but it isn't the best means of testing generics. That said, I think that the generics are good enough, but perhaps they would fail for a rare person with certain body chemistry which a full clinical trial would be more likely to discover.

Last edited by Drewbacca; 05-28-12 at 09:00 PM..
Reply With Quote
Reply

Bookmarks


Currently Active Users Viewing This Thread: 4 (0 members and 4 guests)
 
Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is On
Forum Jump

Similar Threads
Thread Thread Starter Forum Replies Last Post
Adderall side effect question sywi Adderall 110 10-21-16 01:43 PM
adderall Tolerance/dependance MindResearcher ADDiction & Substance Abuse 11 10-13-14 04:29 AM
Strattera give same results as Adderall? Onwari Strattera 27 08-14-13 09:47 AM
Why has generic Adderall XR become "unavailable to order" to many pharmacies? HmmrSwngr Adderall 4 01-28-11 03:27 PM
Desperate For Advice/help For Adderall Issue mel Adderall 15 12-08-04 09:55 AM


All times are GMT -4. The time now is 02:44 PM.


Powered by vBulletin® Version 3.7.4
Copyright ©2000 - 2018, Jelsoft Enterprises Ltd.
(c) 2003 - 2015 ADD Forums