As we move into 2025, some notable topics have surfaced.

Steady State in the PIV Market?

The number of ANDA’s filed associated with a PIV case has remained steady over the past 5 years. In 2024, there were 167 of them filed, down from 173 in 2023. Since 2020, there have been between 167-179 ANDA’s filed each year (except the “Covid-19” year of 2021), a far cry from the peak of 309 ANDA’s filed in 2015. These data suggest that we have perhaps reached a steady state in the PIV Market with a reasonably tight range of ANDA’s filed.

The Filers seem to have changed slightly

While the number of ANDA’s filed has steadied, the filers seemed to have changed, but only slightly. While I have been researching this market for over 20 years, there is a sense that the allure of the aBLA (BPCIA) filing has taken some attention away from the PIV Market. While the market still sees familiar filers (Dr. Reddy’s, Teva, Mylan, Sandoz, eg), there has been a surge of PIV filings from others and new entrants. The next few years will reveal whether the aBLA push pays off for some or whether these aBLA filers may renew focus on the traditional PIV filing. By the way, we do cover BPCIA cases in ParagraphFour.com.

Some Bad Behavior

Unfortunately, the PIV Market in 2024 saw some behavior that some may label “bad” or “abusive” while others might call them “clever” or “aggressive.” I covered one of these events – late-listing of an Orange Book patent — in a prior blog post in February. A second appeared late in the year. This time the litigation strategy involved some so-called “forum shopping.” I will cover this topic in the next PIV Blog post.

Thank you all again for the support of the research for over 20 years! I wish everyone all the best for 2025!