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Guess How Many Authorized Generics Have Been Reported to FDA?

Before we get to the guessing game, for those of you who are not familiar with the term, let’s define what an Authorized Generic (AG) is. Most commonly, an AG is a brand name drug that is marketed without the brand name. It may be marketed directly by the NDA holder or by a third party. So, the AG is actually the same product as the brand name drug.  In some instances, it may have a different logo or it could be distributed with the exact same trade dress as the brand name drug product.

People often get confused about how an AG differs from a generic drug being distributed under different labels.  In the generic world, that is called a private label distributor.  The difference is a bit semantic between an AG and a private label distributor, but the differentiation is important.  For instance, if a generic manufacturer enters the market with an AG (distribution of the brand name drug) in certain circumstances relative to a first-to-file ANDA, this could trigger the first filer’s 180-day exclusivity.  But enough about the differences, the purpose of this post is to have you guess how many AG there are that have been reported to the FDA.

But first, let us note that the requirement for firms to report the marketing of an AG actually arose from the September 27, 2007 passage of the Food and Drug Administration Amendments Act (FDAAA). The Act required FDA to establish a database of AGs.  Firms were to report the marketing of AG in their Annual Reports. The list of AG’s, current through March of 2018, can be found here, but no peeking just yet please!  The AG list describes each strength of product as a unique marketed AG – that is one hint at the potential magnitude of the number.  In addition, the list does not tell you when the actual AG began marketing in all cases, but may be the date of the Annual Report, and the list does not tell you if the AG is still being marketed.

Here are some interesting factoids:

  • In 2017, there were 42 newly reported AG
  • In 2018, through March 28th there have been only 4
  • The oldest one reported that I could find on the list was from 1978 (Amoxil) but I am not certain of the accuracy of the listing as I do not believe the firm that is the AG distributor listed was in existence at the time (or it may be that the firm listed purchased the product and is now the owner).
  • There were many AGs reported in the early 1990s. The first one I remember was from that era, but the list is the list and who am I to argue.

AGs will continue to flourish because they can contribute to brand name revenue especially after a brand name product has gone generic.  Now I am no expert on market forces or factors that influence a firm’s decision to permit an AG, but it appears to be a very popular process.

Enough with all the hints – have you guessed yet?   The line item number on the most recent report was 1132.  Now, that a lot of AGs!