This year’s Annual Review made me reflect on the Paragraph IV Market over the past years. We have reached a new plateau which indicates that the terrain is a bit rocky at this point for anyone participating.

Consistently Fewer ANDA Filings

The high-point of the PIV Market was 2015 which saw a record number of ANDAs filed that were associated with PIV cases. That number reached 309. Since then, the market has seen a decrease in filings and activities. Over the last four years, there have been a steady number of ANDAs filed around 175. Of course, 2021 was exceptionally low (130) likely due to the operational impact of Covid-19 had on generic companies and their ability to file ANDAs.

The most recent numbers represent a 44% decline in ANDA filings (again, associated with PIV cases) since 2015. Of course, fewer filings means fewer PIV cases and their associated activities. Petitions for Inter Partes Reviews have likewise seen a decline.

But Not Everything is Declining

In spite of these data, two market measures have remained steady since 2010. The first indicator is the number of brand products receiving their first PIV cases. This number has remained steady at around 40 products per year. This indicates that there are still many attractive brand products that garner the attention of ANDA filers. I like to think of this figure as a sign of an active, engaged market.

The second indicator is the actual number of new ANDA filers entering the PIV Market. Since the inception of this research in 2003, we’ve noted how many companies have filed their first ANDAs (and then found themselves as defendants in a PIV case.) Every year saw new entrants, and over the past several years, a steady stream of new ANDA filers have entered, hovering at around 10 per year. This is also a sign of a market that is attractive.

Rocky Terrain Ahead

When you take these data together, there are a few possibilities as to what the PIV Market is experiencing. I suspect it boils down to a couple of things. First, several of the larger generic companies have been filing ANDAs at a slower rate and have begun focusing their attention to aBLA biosimilar applications. Perhaps the higher margins and fewer competitors of the aBLA entices with greener pastures, but, I suspect that, given the BPCIA patent infringement cases filed, that terrain may be just as rocky as the PIV Market. The other factor, of course, is how far brand companies will go into producing biologics rather than chemical compounds.

Second, over the past several years there has been another pattern established: small or mid-size generic companies enthusiastically enter the PIV Market, find it difficult and expensive to get their products to market, and then abandon. We’ve seen dozens of companies, both large and small, active in the PIV Market for a few years but then haven’t been seen since. The new replacement ANDA filers have moved in to fill the void.

With this, what can we expect for the next few years? The only thing for certain is that the PIV Market is — and always has been for that matter — rocky. The last time the PIV Market was “easy” was before 2005 or so. But what is the alternative? Waiting until a brand goes off-patent isn’t exactly enticing and the aBLA market may prove the same. Of course, it’s anyone’s guess as to the outcome in the remaining years of this decade – will the PIV Market remain in this lower plateau (44% down since peak) or rebound as more new entrants and old familiar ones start filing more ANDAs?