The PIV Market in 2025 revealed two interesting developments, actually three, but more on that later.

More ANDA’s filed

Of course, we count PIV lawsuits and can count the number of ANDA’s filed included in them. 2025 saw a 25% increase in the number of ANDA’s filed. Out of 272 cases filed, there were 209 ANDA’s. The prior three years were consistently below this figure (from 2024-2022: 167, 173, and 167). These data necessarily exclude ANDA’s filed where the patent holder did not file a PIV case.

Part of this increase represents 9 new filers – those ANDA filers which have previously not appeared in the PIV Market — which is more than years past. In addition, perhaps now that the shutdowns and slowdowns during Covid-19 are behind us, many of the PIV Market’s seasoned participants are hitting their strides and filing more ANDA’s.

Fewer Hyper-competitive Filings

With more ANDA’s filed, you might draw the reasonable conclusion that more products were hyper-competitive, that is, receiving 5 or more ANDA’s at the same time. This usually happens with the NCE-1 products on or shortly after the first possible filing date. Interestingly, this was not the case in 2025.

In 2025, 42 products received their first PIV Certifications.* This is indeed an increase from 2024 (which had 30) but is right in line with the typical numbers the PIV Market sees on an annual basis. The interesting observation is that the ANDA’s were effectively spread out amongst the products in 2025. Only 2 products had 5 or more ANDA filers at the NCE-1 date or shortly thereafter. In both 2024 and 2023, there were 4 hyper-competitive products with 2023 seeing a product that had as many as 10 filers at the inception of its PIV cases.

We will see how the next year or two play out, but perhaps these data suggest ANDA filers are choosing their products more carefully and not simply jumping on the easiest-to-manufacturer or the next blockbuster to reach its NCE-1 date.

The Greener Grass of BPCIA’s?

2025 led to one other interesting observation which involves the aBLA application for a biosimilar. But, it is a broader topic which will be subject of the next Blog Post.

*One technical note: brand companies filed their first PIV cases in defense of their respective products (42 of them) in 2025. Because PIV cases surface a few months after the ANDA filers file their certifications, the certifications for several of these were filed in 2024.