Re: Real vs. Generic Naltrexone

[Guest guest]

I do not believe the Barr Lab generic had 50mgs of naltrexone in it

that I took b/c if so, I would have got the same results as the

Bristol Myers Revia. I went downhill in 3 weeks on generic so I do

not think it was bioequivalent. At least the batch I had. Anyone can

try for themselves but even my mom's doctor told her she would have to

take twice the amount of generic lipitor to get the affects of one

dose of name brand lipitor so that says something to me right there.

And the BM Revia worked for 6 months straight then on generic stopped

and Bruce gave us an explanation about not totally the same makeup

when meds are made which makes sense.

Rhonda

[Guest guest]

THANK YOU MAUREEN FOR THOSE CLARIFICATIONS!!! I AM NEW TO THIS SITE

AND JUST GOT A CALL THIS MORNING THAT MY LDN SHOULD BE ARRIVING

EITHER TOMORROW OR WEDNESDAY. I WAS A BIT WORRIED AND CONFUSED BY

SOME OF THE POSTS IN REGARD TO GENERIC VS REAL UNTIL I SPOKE TO MY

COMPOUNDING PHARMACIST AND NOW YOU HAVE SET MY MIND AT EASE

KNOWING " EVERYTHING IS GOING TO BE ALRIGHT " AS LONG AS I HAVE THE

CORRECT MINDSET TO START THE LDN. THANK YOU AGAIN MAUREEN!

TAMMY W/SECONDARY PROGRESSIVE MS

> To clarify what " generic " naltrexone is --

>

> You need to know a few things.

>

> First of all, the FDA rules state that any generic medication must:

>

> -- contain the same active ingredients as the brand-name 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.

>

> All FDA-approved 50 mg naltrexone pills contain 50mg of Naltrexone

> Hydrochloride (C20H23NO4-HCl). This is the active ingredient, and

> it is the SAME in all versions, whether the original ReVia, or a

> generic.

>

> But it's true, the inactive ingredients may vary. Maybe this

> worries you. So you decide that you want the " real, original

> ReVia " .

>

> But which is the " real, original ReVia " ?

>

> That's a little tricky to know.

>

> The first 50mg naltrexone pill was developed by Dupont and

approved

> by the FDA in 1984 as a treatment for opiate addiction. Dupont

> brand-named this pill Trexan.

>

> In the 1990's, Trexan underwent clinical trials for alcohol

> addiction, and in 1995, the FDA approved it for alcohol abuse.

For

> marketing reasons, Dupont changed the name from Trexan to ReVia.

>

> In 1997, Dupont's market exclusivity agreement expired for ReVia,

> which meant that other companies were now legally free to

> manufacture and market generic naltrexone under FDA standards.

>

> In May 1998, the first generic version of ReVia was produced by

Barr

> Laboratories in Pomona NY, a very reputable pharmaceutical company

> that specializes in generic medications. Dupont continued to

> manufacture brand-name ReVia.

>

> In 2001, Dupont Pharmaceuticals was bought by Bristol Myers

> Squibb, so Bristol Myers Squibb now owned the rights to the brand

> name ReVia.

>

> In April 2002, Bristol Myers Squibb sold the U.S. ReVia brand-name

> rights to Barr Labs, who had already been manufacturing a 50mg

> naltrexone pill.

>

> Now, in 2005, Barr owns the brandname ReVia in the U.S.

> Other generic versions of ReVia are manufactured in the U.S. by

Eon

> Labs, Amide Pharmaceutical and Mallinckrodt Pharmaceuticals, who

> manufacture 50mg and 100mg naltrexone pills under the trade name

> Depade. Outside the U.S., generic versions of naltrexone are

named

> Naltima (manufactured by Intas, the largest pharmaceutical company

> in India) and Narpan (manufactured by Duopharma in Malaysia).

> Bristol-Myers Squibb, as I understand it, manufactures its version

> of ReVia, but markets it only through Bristol-Myers Squibb de

> Mexico.

>

> So which one is the " real " one?

>

> I think it's hard to know, at this point. The active ingredient,

> naltrexone, is the same in all of them. The inactive ingredients

> might differ, and if that makes a difference to you personally,

then

> you should try and get the one that you feel works best for you.

>

> But I believe that arguing whether " generic " is better or worse

> than " real " ReVia is not profitable to any of us, and might be

> confusing to our new members.

>

> Just my two cents. Sorry for the length of this post. I'll shut

up

> now.

>

> -- Maureen