Real vs. Generic Naltrexone

[Guest guest]

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