The FDA keeps track of first generic drug approvals for each calendar year and just posted the number for the first six months of calendar year 2024 here. Be aware that the OGD also posts first approvals in its Generic Drugs Program Monthly and Quarterly Activities Report (here) but the first approvals posted on this report are by fiscal year (FY) so you may see some discrepancies in the totals that the OGD reports based on whether the report is for the calendar or fiscal year.
We have looked at the past nine and a half years of first generic approvals. Remember that a first generic approval is exactly what it sounds like – it is the first generic of a particular product approved in a specific dosage form, strength, and active ingredient as that of the Reference Listed Drug (RLD) it is copying. However, a first generic may not be rated as therapeutically equivalent to a RLD if the product is approved based on a permitted change in a product (e.g., dosage form strength, route of administration, etc.) through an approved ANDA suitability petition. Also note that, if multiple applications are approved on the same day that fit the above criteria, they are also recorded as first generic approvals; thus, the total number may reflect multiple applications for the same product.
The numbers are remarkably similar from year to year as the chart below demonstrates. The number of first generic products approved can differ from year to year based on issues such as the number of new products coming off patent, products for which patent challenges are won, or where there is exclusivity that may delay approval of a first generic ANDA, among other reasons.
First Generic Approval by Calendar Year
*First six months of calendar year 2024
As you see, the numbers of first generic approvals are consistent, going from 72 to 107, as would be expected based on a number of variables, some of which are outlined above. The number is also highly influenced by the number of New Drug Applications (NDAs) approved for different entities. Kind of obvious but the more targets you have to copy, the more first generic approvals you may expect to see in a given year if none of the regulatory barriers, like patents and exclusivity, stand in the way of approvals.
When the calendar year is over, we will report back on the total number of first generics approved in 2024.
