Brand versus Generic

[Aznfarmerboi]

Lets admit it, a generic is not equal to brand in many aspects. Who here really prefers the generic over the brand 100 pecent of the time? I am sure generic Ambien will still knock you out in 10-30 minutes, but what about nicotine patches? A generic mouthwash or diphenhydramine?

What are some of the things/drugs you would rather take brand instead of generic? Low therapeutic drugs do not count.

[pharmagirl]

In general I always prefer generic because of the price difference, even with OTCs. There are a few things like Tums that I'll buy brand just because I prefer the taste. (The smoothie type are so yummy! )

[Priapism321]

Originally Posted by Aznfarmerboi

Lets admit it, a generic is not equal to brand in many aspects. Who here really prefers the generic over the brand 100 pecent of the time? I am sure generic Ambien will still knock you out in 10-30 minutes, but what about nicotine patches? A generic mouthwash or diphenhydramine?

What are some of the things/drugs you would rather take brand instead of generic? Low therapeutic drugs do not count.

I prefer generic 100 percent of the time. You claim there are many aspects that render generics inferior, but give zero examples.

[genesis09]

I use generic diphenylhydramine and it works great. I've never had a problem with any generic drug. I'll take brand over generic if it is cheaper.

[Doctor M]

diphenhydramine knocks me out pretty good. I took generic omperazole and it works fine. There may be solubility differences in the body after taking a brand name but most of the time your body will get use to it. I orefer generics 100% of the time.

[Doctor M]

Originally Posted by Aznfarmerboi

Lets admit it, a generic is not equal to brand in many aspects. Who here really prefers the generic over the brand 100 pecent of the time? I am sure generic Ambien will still knock you out in 10-30 minutes, but what about nicotine patches? A generic mouthwash or diphenhydramine?

What are some of the things/drugs you would rather take brand instead of generic? Low therapeutic drugs do not count.

How so? name examples please.

[Epic]

Originally Posted by Aznfarmerboi

Lets admit it, a generic is not equal to brand in many aspects. Who here really prefers the generic over the brand 100 pecent of the time? I am sure generic Ambien will still knock you out in 10-30 minutes, but what about nicotine patches? A generic mouthwash or diphenhydramine?

What are some of the things/drugs you would rather take brand instead of generic? Low therapeutic drugs do not count.

That's right...keep buying brand...cuz it'll keep my drug company stock prices up!

[Hokie Grad]

Originally Posted by Aznfarmerboi

Lets admit it, a generic is not equal to brand in many aspects. Who here really prefers the generic over the brand 100 pecent of the time? I am sure generic Ambien will still knock you out in 10-30 minutes, but what about nicotine patches? A generic mouthwash or diphenhydramine?

What are some of the things/drugs you would rather take brand instead of generic? Low therapeutic drugs do not count.

I can't believe there are pharmacists who still don't get this:

generic = same amount of API in blood as branded product. A generic drug company has to prove this by filing an ANDA which takes about 18 months to complete and another 12-15 months to review and approve. In fact the API can be and is often sourced from the same API manufacturer that supplies the brand.

I'm not sure how long it will take generic ambien to knock you out, but I am reasonably certain that it will deliver the same amount of zolpidem to your blood stream as you would get from the brand.

Hope this is helpful.

[Aznfarmerboi]

Hokie, while this is true, I wasnt referring to that. I was referring to other things. For example, lets look at the market experience. Acetaminophen from tylenol have more than 50 years of experience, while acetaminophen from a generic company that recently started has 0. A patient might feel better swallowing their capsules which are smaller, or easier to go down.

In terms of "bioequivalence", there are many cases where different therapeutic responses are not seen as equal. Two or more products might appear "identical" or "equivalent" because they contain the same drug, in same dosage strength, and in the same dosage form. However, if the formulation materials such as diluents, binders, disintegrants, lubricants, are not the same, then it is possible the product might exhibit differences. For example, dilantin toxicities in the late 1960's (long time ago, but not really) in Australia (not USA FDA, but still). The toxicity was due to a domestic product, binder, that released more dilantin, increasing the bioavailibity. Digoxin was another example that exhibited varying avaibility from different manufactueres, although the dosage form was the same. Just the method of manufactuer might change the whole entire picture. This is the reason why we are not allow to change a patient who have been on synthoid to another one, etc.
While, we have gone a long way since the 60's and the FDA does requires dissolution test to make sure everything is okay now, not all "generic" are equal still. For example, I do have a few complaints of customers saying that the nicotine patch do not "Stick" as well. The ointment base that a medication is in might be different as well. While a drug might be equal, it might take longer for the same drug made by different manufacters to reach their peak differently (even though the AUC is still the same), etc.

My original post was still referring to other stuff, hence things/drugs. So for example, give me the real oreo over pathmark oreo. That is still generic.

[SCal]

I prefer brand, I think it's just a matter of personal preference...You believe in it then it'll work, vice versa

[Epic]

Originally Posted by Aznfarmerboi

Hokie, while this is true, I wasnt referring to that. I was referring to other things. For example, lets look at the market experience. Acetaminophen from tylenol have more than 50 years of experience, while acetaminophen from a generic company that recently started has 0. A patient might feel better swallowing their capsules which are smaller, or easier to go down.

So, if a newer company makes an even smaller caplet... then the generic is better?

Originally Posted by Aznfarmerboi

In terms of "bioequivalence", there are many cases where different therapeutic responses are not seen as equal. Two or more products might appear "identical" or "equivalent" because they contain the same drug, in same dosage strength, and in the same dosage form. However, if the formulation materials such as diluents, binders, disintegrants, lubricants, are not the same, then it is possible the product might exhibit differences. For example, dilantin toxicities in the late 1960's (long time ago, but not really) in Australia (not USA FDA, but still). The toxicity was due to a domestic product, binder, that released more dilantin, increasing the bioavailibity. Digoxin was another example that exhibited varying avaibility from different manufactueres, although the dosage form was the same. Just the method of manufactuer might change the whole entire picture. This is the reason why we are not allow to change a patient who have been on synthoid to another one, etc.

This doesn't support your argument of brand being better. So if patient was started on generic, then generic is better for the patient...since we don't want to swap... then again, for every one of your exceptions...I'll give you 100 generics that we can sub with no issues.

Originally Posted by Aznfarmerboi

While a drug might be equal, it might take longer for the same drug made by different manufacters to reach their peak differently (even though the AUC is still the same), etc.

My original post was still referring to other stuff, hence things/drugs. So for example, give me the real oreo over pathmark oreo. That is still generic.

Again, you haven't built a case to say why brand is better....just brand may be different than generic because of fillers..

[Aznfarmerboi]

yeah, but i never said brand was better. . ., i just ask who prefer what. . . which was what most of the ppl answer with lol. . .

[Epic]

Originally Posted by Aznfarmerboi

yeah, but i never said brand was better. . ., i just ask who prefer what. . . which was what most of the ppl answer with lol. . .

My original post was still referring to other stuff, hence things/drugs. So for example, give me the real oreo over pathmark oreo. That is still generic

why would anyone prefer brand if they didn't think it was better

[confettiflyer]

funny i saw a Tylenol commercial today...basically a bunch of PR interviewing of regular employees and their "passion" for quality and knowing their product goes into patients. Then an off handed comment essentially saying, "tylenol...trust us over the generics."

Makes you feel real good about taking the brand!

[Sosumi]

America is based around brand loyalty. That's why advertising is so important and such big business. Btw, isn't Ambien and zolpidem currently made by the same manufacturer anyway?

[Epic]

Originally Posted by Sosumi

America is based around brand loyalty. That's why advertising is so important and such big business. Btw, isn't Ambien and zolpidem currently made by the same manufacturer anyway?

hey...is you a licensed druggist now??

I remember when you were a kid... I think you responded to my "Who's got info on Aminoglycoside?" thread!

There are many brand and generics manufactured by the same company..just packaged differently.

[confettiflyer]

speaking of this discussion....

http://www.msnbc.msn.com/id/21142869/

whoops. Synopsis: Study finds that budeprion XL doesn't work as well as its brand.

NOTE: study wasn't traditional, done by some group called consumerlab.com. just thought i'd post this here!

[Aznfarmerboi]

I just read that post too confetti and thought to myself, wow. . . let me post this up too. However, the article doesnt have much quotations except to consumerreport (which in my opinion, is a good research company), but not acceptable in the clinical world. However the line that as FDA moves to speed the generic approval process faster, we should pay more attention to it.

[sdn1977]

Originally Posted by Aznfarmerboi

Hokie, while this is true, I wasnt referring to that. I was referring to other things. For example, lets look at the market experience. Acetaminophen from tylenol have more than 50 years of experience, while acetaminophen from a generic company that recently started has 0. A patient might feel better swallowing their capsules which are smaller, or easier to go down.

In terms of "bioequivalence", there are many cases where different therapeutic responses are not seen as equal. Two or more products might appear "identical" or "equivalent" because they contain the same drug, in same dosage strength, and in the same dosage form. However, if the formulation materials such as diluents, binders, disintegrants, lubricants, are not the same, then it is possible the product might exhibit differences. For example, dilantin toxicities in the late 1960's (long time ago, but not really) in Australia (not USA FDA, but still). The toxicity was due to a domestic product, binder, that released more dilantin, increasing the bioavailibity. Digoxin was another example that exhibited varying avaibility from different manufactueres, although the dosage form was the same. Just the method of manufactuer might change the whole entire picture. This is the reason why we are not allow to change a patient who have been on synthoid to another one, etc.
While, we have gone a long way since the 60's and the FDA does requires dissolution test to make sure everything is okay now, not all "generic" are equal still. For example, I do have a few complaints of customers saying that the nicotine patch do not "Stick" as well. The ointment base that a medication is in might be different as well. While a drug might be equal, it might take longer for the same drug made by different manufacters to reach their peak differently (even though the AUC is still the same), etc.

My original post was still referring to other stuff, hence things/drugs. So for example, give me the real oreo over pathmark oreo. That is still generic.

You have quite a bit of information that is wrong.

In the case of Dilantin, it was only discovered the Dilantin product has a long acting formulation after it was off patent. It was not designed that way, rather that was discovered after new manufacturers got into the market. They don't even quite know why the product has such a stable controlled blood level property that it does. That is why today, we have generic phenytoin & brand name Dilantin. No, they are not interchangeable, but that does not make one over the other better. You just titrate the individual.

Premarin is an example of a drug which can't be marketed as a generic because they can't get the exact amount of each component. But, that market has fallen way off anyway. But, that was the primary reason synthetic estrogens were developed - to be able to refine & define the basic drug which helped Estradiol & much later all the generics which came after.

The levothyroxine issue is longer & has a far more interesting history. Synthroid was the first manufacturer & has been in the market for over 40 years, altho the company making it has changed hands many times. The Synthroid drug itself has also changed as well. It was reformulated in 1981, an exciepient was added to the 50mcg tablet in 1983. In 1989 the dyes were changed in 3 of the strengths & in 1991, the exciepient was removed from the 50mcg tablet. Synthroid along with every other levothyroxine product had to undergo NDA applications in August 2000. That is when they were are define bioequivalently with the reference drugs being Synthroid & Levoxyl.

Then we get to the issue of the bioequivalence study of levothyroxine done by Dr Dong at UCSF in the 80's. It was demonstrated there was no significant difference. But, politics, money & pressure prevented the study from being published. (This was a HUGE scandal!!!) It was resurrected much later & bioequivalent has been indeed be demonstrated. The bioequivalence codes for levothyroxine products are a bit more complicated than for other drugs, but they are rated AB1, AB2, AB3 or BX depending on how the compare based on the reference drug.

Levothyroxine is inherently an unstable drug & is subject to recalls frequently due to this very instability.

And, as part of each ANDA, the manufacturer does indeed have to demonstrate dissolution characteristics as well as adhesive properties, in the case of patches. But, the variants are not in the drug product itself, more in the patient, particularly the skin of the patient. I have many, many patients who prefer the adhesive properties of the Mylan fentanyl to the Duragesic fentanyl (no - not due to the ease of removing the fentanyl). Some will react to the adhesive or it will not "stick" - but those same folks will buy BandAid, Curad or store brand.

For myself, I will use generic drugs anytime because I know they are the same. However, I buy brand name Cheerios, Best Foods mayonaise (west of the Rockies) and Dreyer's ice cream. They taste better to me. I prefer the taste of Hydrox cookies to Oreos & just won't buy a store brand of either.

[Epic]

Only a very old pharmist would know this stuff

[Old Timer]

Originally Posted by sdn1977

In the case of Dilantin, it was only discovered the Dilantin product has a long acting formulation after it was off patent. It was not designed that way, rather that was discovered after new manufacturers got into the market. They don't even quite know why the product has such a stable controlled blood level property that it does. That is why today, we have generic phenytoin & brand name Dilantin. No, they are not interchangeable, but that does not make one over the other better. You just titrate the individual.

I think you might be wrong on this one. Dilantin is considered to be Phenytoin Sodium Extended. All previous generic versions were Phenytoin Sodium Prompt and carry a BX rating. The first AB rated generic was not approved until 1998. A few others followed over the years according to the Orange Book.

Originally Posted by sdn1977

I prefer the taste of Hydrox cookies to Oreos & just won't buy a store brand of either.

Say it ain't so.... Even if you do have great legs, you don't know cookies. A bag of Oreos and a 1/2 gallon of milk. The greatest dessert ever....

[sdn1977]

Originally Posted by Epic

Only a very old pharmist would know this stuff

Thank you sir! However, a gentleman would never mention a lady's age, only how good her legs look.

[sdn1977]

Originally Posted by Old Timer

I think you might be wrong on this one. Dilantin is considered to be Phenytoin Sodium Extended. All previous generic versions were Phenytoin Sodium Prompt and carry a BX rating. The first AB rated generic was not approved until 1998. A few others followed over the years according to the Orange Book.


Say it ain't so.... Even if you do have great legs, you don't know cookies. A bag of Oreos and a 1/2 gallon of milk. The greatest dessert ever....

Ha, Old Timer! No - it is "now" considered phenytoin sodium extended. However, it was not known originally it was an extended forumulation. When the patent expired, manufacturers made it, but the kinetics were not the same. That's when PD realized it was an extended release formulation - thus.....the development of the phenytoin prompt formulation.

btw.....PD didn't really even invest in the drug until nearly the end of its patent life & it purchased the drug in 1908. But, when it did, it pushed it hard & unfortunately paid a price. During the 90's it suffered quality control issues & by then, Warner-Lambert owned the drug & paid $10 million in fines due to these issues. I think the patent ended in the early 70's, but generic manufacturers coudn't dupicate the AUC or kinetics....thus the studies. I know there was a lab (probably down the hall from Dr. Dong) who was also doing kinetic studies at UCSF. So...they discovered the phenytoin prompt & later were able to duplicate the extended release phenytoin. The interesting part about this whole thing is the original product was extended release, but they didn't know it nor did they originally set out to make it.

A few other really interesting things about Dilantin:

Jack Dreyfus (of the Dreyfus Fund) put a SIGNFICANT amount of money into this drug because of how it changed his life in 1966 after he got an rx for it for depression in 1966. Makes you think differently about SSRI's???

Richard Nixon was supposedly given lots of rxs for it - it was used for depression at the time......gives new insight perhaps into not just depression, but his presidency & decisions?? (does anyone but me remember Watergate?????) Wonder what kind of a president Hubert Humphrey might have made - huh??? (For those who don't know - he was Lyndon Johnson's vice president & a pharmacist & ran against Richard Nixon).

Also, Dilantin got a lot of publicity since it was one of the major drugs used in One Flew Over the Cuckoo's Nest (the book) in 1962 since it was used not just as an anticonvulsant, but also to control inmates behavior.

Dilantin has an interesting past.......

[Epic]

Originally Posted by sdn1977

Thank you sir! However, a gentleman would never mention a lady's age, only how good her legs look.

I'm no gentleman when it comes to good looking legs..

[sdn1977]

Originally Posted by Epic

I'm no gentleman when it comes to good looking legs..

Again - I thank you sir!

[Old Timer]

Originally Posted by sdn1977

Ha, Old Timer! No - it is "now" considered phenytoin sodium extended. However, it was not known originally it was an extended forumulation. When the patent expired, manufacturers made it, but the kinetics were not the same. That's when PD realized it was an extended release formulation - thus.....the development of the phenytoin prompt formulation.

I wasn't questioning the history lesson. What I was commenting on was the fact there is presently an AB Rated version of phenytoin sodium extended. As I said. it was not approved until 1998, while the patent on Dilantin had run out years before. They are interchangeable and legally substitutable, at least in Pennsylvania.

[sdn1977]

Originally Posted by Old Timer

I wasn't questioning the history lesson. What I was commenting on was the fact there is presently an AB Rated version of phenytoin sodium extended. As I said. it was not approved until 1998, while the patent on Dilantin had run out years before. They are interchangeable and legally substitutable, at least in Pennsylvania.

Goodness! You are soooooo literal tonight!

My comments were directed to Anzfarmerboi's initial comments on Dilantin.

But - I accede to your last word on the AB rating of Dilantin & the legal substitutability of the great state of Pennsylvania.

Lighten up!

[Old Timer]

Originally Posted by sdn1977

But - I accede to your last word on the AB rating of Dilantin & the legal substitutability of the great state of Pennsylvania.
Lighten up!

First of all it's the Commonwealth of Pennsylvania.

Second, I did say nice things about your legs...

Finally, you didn't say anything about the Oreos V Hydrox comment

[sdn1977]

Originally Posted by Old Timer

First of all it's the Commonwealth of Pennsylvania.

Second, I did say nice things about your legs...

Finally, you didn't say anything about the Oreos V Hydrox comment

I already said I like Hydrox over Oreos - its just a personal preferance - nothing to argue or discuss.

Then.....I guess its just hard to take the whole rest of it lightheatedly when you are so d*mn serious about everything - CVS particularly - you might want to give that whole thing a rest, but that again is just an opinion.

But - I do apologize. I must admit I only hear when they announce who voted for whom during the primaries. I guess I heard the great state of Pennsylvania rather than the great Commonwealth of Pennsylvania. I will admit I lose interest soon (altho obviously not in 1968 Humphrey/Nixon race).

Finally, thanks for the legs comments. I think you're a bit late to the joke, but thanks nonetheless.

Again - I hand you the last word! You are again right......

[Old Timer]

Originally Posted by sdn1977

Then.....I guess its just hard to take the whole rest of it lightheatedly when you are so d*mn serious about everything - CVS particularly - you might want to give that whole thing a rest, but that again is just an opinion.

If you look carefully, I have stayed away from the CVS threads recently. They know where I stand and as I have said many times, I prefer clarity to agreement.

Good Night m'lady......

[Epic]

get a room...you 2 old farts..

[sdn1977]

Originally Posted by Epic

get a room...you 2 old farts..

What would we do with that???? You never told us all about those drugs that end in .......fil. (That was a good topic too btw - different thread)

[Epic]

I'm drivin
Lookin @ manhattan

[sdn1977]

Originally Posted by Epic

I'm drivin
Lookin @ manhattan

and texting at the same time?

[Epic]

Yup

[golf299]

It is my understanding from what we were told in P1 year that generics must be 80-120% the bioequivalence of the brand name drug.

[PharmDstudent]

Originally Posted by golf299

It is my understanding from what we were told in P1 year that generics must be 80-120% the bioequivalence of the brand name drug.

On page 23, which is 26 on the Adobe page count, http://www.fda.gov/cder/guidance/5356fnl.pdf, the FDA says that the confidence interval has to be within the 80 to 125 range. If there are any factors that could contribute to this in a bad way, like poor solubility, absorption, or distribution, it could be hard for a generic to pass that standard. They should probably have a bioequivalence closer to 90-110% for the sake of meeting the standard- that would give them more wiggle room.

Supposedly in Australia they have to meet a 90% standard for their generics. I've thought about moving there, but I haven't done the adequate research yet. The summers wouldn't be so hot and since I live in the South, I don't worry about a white Christmas.