First Time Generic Approvals for FY 2016 – The Final Numbers

Back in May 2016, we did an update on the number of first generic approvals over the last 3 and one partial fiscal year (FY) since GDUFA’s implementation (here).  Well, last week, the Office of Generic Drugs (OGD) published its list of first-time generic approvals for the full 2016 FY and now we can update the table we posted in May.

So, what do these numbers tell us?  One might think on first look that OGD is having trouble getting first generic approvals out, but that might not be an accurate assessment.  In a presentation at this year’s GPhA Fall Technical Conference (here), Katherine “Cook” Uhl noted that there are 313 innovator drugs with no approved generics that are protected by patent or exclusivity (nothing OGD can do about these until the period of protection expires; there is a court decision in favor of generic firms or the 30-month period expires after notice is given in a Paragraph IV challenge, if the generic firm is sued); 125 innovator drugs with no approved generics and for which there are no ANDAs submitted (nothing OGD can do about these products until an ANDA is submitted); and 25 innovator drugs with pending ANDAs (these OGD can act on).  Therefore, at this point in time, one could only expect that OGD could approve 25 additional products as first-time generics; however, there is no indication as to when these ANDAs were submitted and, thus, even if they receive expedited review, we have no idea as to when they may be ready for approval.

As more and more generic drug products are approved (and OGD has approved 1549 ANDAs and tentatively approved 490 through the first full 4 years of GDUFA [of which 357 were first generic approvals]), there are fewer first generics that can be approved as the number of new product hovers at about 100 new NDAs a year.  While there are limitations on the numbers of first generic approvals that are impacted by patent and exclusivity, there are questions that arise about the 2^nd, 3^rd, 4^th, etc., approvals that could help significantly by lowering prices of generic products.  We have no data on that aspect of the current pricing debate upon which to comment.  What we do know is that generic drugs save consumers, and the federal and state governments, billions of dollars over the years.