Replies to post #100271 on Biotech Values

[bladerunner1717]

Dew,

I admit to being a bit confused by the two terms. If the branded drug manufacturer licenses out its drug to a generic drug maker, is that considered a branded generic or an authorized generic?

If SNY brings forward an authorized generic? under what brand name will it be commercialized? (I'm assuming it can't be under the SNY brand.)

If my feeble brain is getting closer to understanding this, then what is an unbranded generic? If there is no such thing as an unbranded generic, then why even bother to use the term branded generic, unless it is solely used to distinguish it from authorized generic?



Bladerunner

[biomaven0]

“branded generic” where he should have said “authorized generic.” This seems to be a common mistake, but I don’t understand why.

For a while I think the terms were virtually synonymous. For example a quote from this paper:

“BRANDED GENERICS” AS A STRATEGY TO LIMIT
CANNIBALIZATION OF PHARMACEUTICAL MARKETS
David Reiffen
US Commodity Futures Trading Commission
and
Michael R. Ward
University of Texas, Arlington
May, 2005

Beginning in late 1992,
several producers of drugs with soon-to-expire patents introduced, or authorizing the introduction
of, generic versions of their important products just prior to patent expiration. We refer to such
products as branded generic or authorized generic drugs.

The following from 2005 is similar:

The U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court's granting of summary judgment for the U.S. Food and Drug Administration (FDA) ruling that the Hatch-Waxman amendments do not prohibit the holder of an approved new drug application (NDA) from marketing a "branded generic" version of its drug during the 180-day exclusivity period provided to the first to file an abbreviated new drug application (ANDA) to market a generic drug. Teva Pharmaceutical Industries v. Crawford, Case No. 05-5004 (D.C. Cir. June 3, 2005) (Ginsburg, C. J.).

Subsequently the term "branded generic" started to be used to describe generics marketed by brand name companies (mostly ex-US for prescription drugs) and I agree it now makes sense to make this the exclusive usage.

Peter

[Mpower]

I noticed that as well Dew. I think "authorized generic by the branded manufacturer" comes to mind ... analysts mistakingly shorten it.