Office of Generic Drugs Updates First Generic Approvals List for 2019

Today, OGD updated its first generic approvals list (here).  So far this calendar year, OGD reports 43 first generic approvals through April 26, 2019.  The FDA notes:

“First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States.  FDA considers first generics to be important to public health, and prioritizes review of these submissions.

It should be noted that, if the “first generic” is approved on the same day but for a different company, they are counted as multiple first approvals in the table.  Thus, for the 43 first generics reported so far this year, there were 15 duplicates; therefore, while there were 43 distinct first generic actions, there were only 28 separate first entities or strengths approved.  This does not diminish the fact that there are a potential 43 new generic ANDAs that will likely hit the market.  Unfortunately, one must also remember that the approval of an ANDA is no guarantee when (or if) that product will be launched.

The Agency also acknowledges that a first generics product in this context is one “(1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product.”

The list is usually updated quarterly, and we will keep you informed of revisions to the list periodically.