First

First-Time Generic Drug Approvals 2019 through November 8, 2019

There have been eighty-six first-time generic approvals for the calendar year 2019 thus far, at least through November 8, 2019, according to the updated list by the FDA (here).  The FDA wants us to remember that first approvals do not always translate into products that are immediately available to the public due to either patent issues, manufacturing issues, market conditions, or other complex factors like insurance coverage and exclusionary contracts.

Of interest is that multiples of the same product approved on the same date are also counted as first approvals because they are approved at the same time.  If you remove the products where more than one ANDA was approved for the same product, then you must subtract twenty-six from the total of eighty-six.  However, this is a pretty good year for first approvals at eighty-six – in 2018 there were ninety-nine, in 2017 there were eighty, and in 2016 there were seventy-three first generics reported by the FDA (see here for more details).

There are a lot of factors that can impact first generic totals for a particular calendar year, including patent expirations, exclusivity expirations, patent settlements, etc.  Thus, predicting how one year may stack up against another year is not something that is really a fair thing to do.  Let’s just say that out of the last four years, 2019 was pretty good for patients and leave it at that.

Some examples of first approvals for 2019 include digoxin oral solution, pregabalin capsules (generic for Lyrica), Bosentan generic for Tracleer, and naloxone nasal spray generic for Narcan, just to name a few.