Generic vs. Trade - does it matter which is used in a bioequivalent?

[Jedi of Zen]

Let's say company A creates a new drug, gets it patented, and begins manufacturing it under a proper trade name (and they do so exclusively, under the patent terms, of course). Once the patent ends, let's say company B comes along and decides to start making and selling a bioequivalent. In this situation, is company B required to use the generic name? Or are they allowed to simply create a new trade name? Or does it matter which choice they make?

Let's say they go with the generic name. If a third company, company C , then comes along and wants to make and sell their own bioequivalent, is company C forced to create a new trade name, or can they also use the generic name?

And if company B had chosen to simply create a new trade name, what would company C's options be? ie, could they then use the generic name, or would they be required to make their own trade name?

Finally - and this is just kind of a side question, really - whenever you go to the pharmacy, you will hear people talk about "generic versions" of a drug. Is the term "generic version" simply a layman's term for "bioequivalent"?

Thanks in advance for the replies.

[APBT mom, LPN, RN]

let's say company a creates a new drug, gets it patented, and begins manufacturing it under a proper trade name (and they do so exclusively, under the patent terms, of course). once the patent ends, let's say company b comes along and decides to start making and selling a bioequivalent. in this situation, is company b required to use the generic name? generic and bioequivalent are interchangeable. or are they allowed to simply create a new trade name? they an if they want to.ex. generic name=ibuprofen brad names= motirn, advil..... or does it matter which choice they make? the companies are not allowed to use the same brand name. so two ompanies can't use motrin for their pain reliever.

let's say they go with the generic name. if a third company, company c , then comes along and wants to make and sell their own bioequivalent, is company c forced to create a new trade name, or can they also use the generic name? they can use the generic name but have to change the brand name.

and if company b had chosen to simply create a new trade name, what would company c's options be? ie, could they then use the generic name, or would they be required to make their own trade name? going to use the same example as above generic=ibuprofen brand name= (co a) advil, (co b) motrin, (co c) excedrin ib

finally - and this is just kind of a side question, really - whenever you go to the pharmacy, you will hear people talk about "generic versions" of a drug. is the term "generic version" simply a layman's term for "bioequivalent"? yes

thanks in advance for the replies.

i know that they explain it in class and it can get confusing. if you have a drug book the top name that is in lower case is the generic and the names underneath are all of the brand names that fall under that generic name.

[elkpark]

The generic name is the legal, official name of the actual chemical compound, and that doesn't change. Think of window cleaner -- they're all, basically, diluted household ammonia in a spray bottle, but lots of different trade names (Windex, Sparkle, lots of others). Same with drugs -- ibuprofen is ibuprofen, whether the manufacturer chooses to market it as Motrin, Advil, or simply ibuprofen. That's why, even when the box or bottle has a big, colorful trade name in several places to catch your eye, somewhere on the label it will say (usually in v. small print :) ) "Active ingredients: ibuprofen USP, 200 mg" (or whatever the generic name of the drug is).

If each manufacturer used a different generic name, we'd never know what we were buying!

[CT Pixie, BSN, RN]

Just to add to the confusion..

Say a company, let call it "ROLLING IN THE DOUGH" has a patent for ABC drug, the patent lasts 10 years (I believe), once the patent ends, other companies are free to make the medication. Well, guess what, lots of pharmacitucal companies also own other pharmacutical companies, so they then make the "generic". So now company "ROLLING IN THE DOUGH" makes money off the trade name drug ABC and its other company makes the generic equivalant so they are making money either way, whether the patient wants the brand name or the generic.

I leared that while working in the pharmacy. And a good friend works for a HUGE pharacutical company.

[justme1972]

Our nursing instructor made it very clear to us that generic vs trade drugs were not equivalent. She said that the active ingredient was the same, but the other substances that were used in the drug manufacturing, were not, which can affect the absorption rate or it's effectiveness.

[RheatherN, ASN, RN, EMT-P]

totally on board with what "hopefull" said. the meds are not always the same chem compound because each company uses diff stuff. IE: if a pt is on coumadin, they may not be able to have warfarin. They will get a prescription that says "BRAND NAME ONLY". Some ppl have major SE's with changes of drugs because it is the HECK OF A LOT CHEAPER one. and that sucks, i have come across a few ppl that has happened to. so when you send a pt home from hosp, we have to tell them not to switch brands w/out telling your MD first.

Pretty screwy dewey huh?

-H-

[CT Pixie, BSN, RN]

Our nursing instructor made it very clear to us that generic vs trade drugs were not equivalent. She said that the active ingredient was the same, but the other substances that were used in the drug manufacturing, were not, which can affect the absorption rate or it's effectiveness.

:yeahthat:

Yup, the active ingredient is the same, but other drug manufacuring companies may use another ingredient that alters the med. Even something as simple as the dye color used for the med can really have a consequence. I know that I had taken Vibramycin with no problem. Then I took the generic doxycycline and again had no problem, refilled my rx got doxy (different manufacturing company from the first doxy script) again but THIS time I had a horrid reaction to the med. My doc and the pharmasist agreed that it was probably the dye used for the color of the pill that I had a reaction to, since all the ingredients were the same. So I was told to just put I have a doxy allergy to ward off any reaction to the generic med.

[Jedi of Zen]

Thanks to all for the replies. I'm still a little confused, though.

Let me use an example, if I may: A family member of mine has a prescription for what he has always been told by his doctor is "generic Wellbutrin". When he gets his prescription filled at the pharmacist, it says "Bupropion" on the label. Underneath the word "Bupropion", it says "(Generic for Wellbutrin)".

Does that mean that "Bupropion" is the universal, generic term for Wellbutrin? In other words, is another company simply marketing Wellbutrin with use of the generic name only? (I didn't think a company could do that; I thought they were always required to create their own brand name...?)

OR, is "Bupropion", in fact, simply a different brand name being used by a different company?

[CT Pixie, BSN, RN]

thanks to all for the replies. i'm still a little confused, though.

let me use an example, if i may: a family member of mine has a prescription for what he has always been told by his doctor is "generic wellbutrin". when he gets his prescription filled at the pharmacist, it says "bupropion" on the label. underneath the word "bupropion", it says "(generic for wellbutrin)".

does that mean that "bupropion" is the universal, generic term for wellbutrin? in other words, is another company simply marketing wellbutrin with use of the generic name only? (i didn't think a company could do that; i thought they were always required to create their own brand name...?)

or, is "bupropion", in fact, simply a different brand name being used by a different company?

wellbutrin is the brand name, it is the name the company who developed/invented the drug named it, buprorion is generic name.

generic name: bupropion

brand name: wellbutrin, wellbutrin sr, wellbutrin xl, zyban

[elkpark]

Generic drug manufacturers are required to test their drugs and verify that they contain the same active ingredients, dissolve and enter the bloodstream at about the same rate, produce the same blood levels, etc., as the brand name drugs in order to sell them in the US. In most cases, people do fine with generic medications, which are typically substantially less expensive than the name brand versions -- but that certainly doesn't mean that there aren't some individuals who get a better response from the name brand drug than a generic version; it depends on how sensitive your system is, how complicated/sophisticated the "extra" components of the medication (like the timed-release mechanism) are and whether or not the generic manufacturers can copy that part of the medication exactly, and things like the fillers or dyes used in tablets. In those cases, it is certainly worthwhile to stick with the specific "brand name" version.

That certainly does not mean that generic medications are, across the board, inferior in any way to name brand medications.

There is no requirement for companies to create a "brand name" for medications. Brand names are created for marketing purposes and advertising campaigns, so the company can spend a lot of money to try to convince you that it's v. important that you take their brand of a very common drug. Most manufacturers of generic drugs aren't marketing to the general public anyway (they are marketing to hospitals and pharmacies, which are not impressed by advertising campaigns and shop mostly by price), so they don't spend the extra money on a brand name and ad campaign. That's one of the reasons their versions of the drugs are less expensive.