At the end of October, the PIV Market saw a rather curious case emerge. Abbvie filed a PIV case against 9 ANDA filers in defense of Orilissa®(elagolix). All 9 filers filed their ANDAs on the NCE-1 date and are thus “first filers.” Does this case signal that the PIV Market has lost its steam, interest from ANDA filers, or perhaps has hit the trench?

A bit of a surprise

In the past, there have been 40 brand products that received great interest from ANDA filers. These products had nine or more ANDA filers filing on the NCE-1 date. But what makes this case a bit of a surprise are two things: (1) No brand product had received as many (or more) ANDA NCE-1 filers in the prior two years (2020-2021) and (2) Orilissa is not a blockbuster seller. Nowhere near the $1B in sales per year mark, this product made $139M in 2021, and increase of 15% from 2020.

Bucking the trend

Products that receive 9 or more ANDA NCE-1 filers are not that common. A vast majority of brand products will receive only 1 ANDA NCE-1 filer or a more manageable number like 2 or 3. Some economists might label such a generic market as “hyper-competitive” where the market really as too many ANDA filers filing on one brand product. Regardless of what you call it, a large number of products (9+ in this case) leaves the market nearly unmanageable for all of the ANDA filers.

When examining Paragraphfour.com and FDA data, the Orilissa filings indeed buck the trend over the past few years. As the PIV Market was gathering momentum after 2013 with more multi-ANDA filer products year-over-year, the PIV Market reached a high point in 2018: 9 brand products received at least 9 ANDA NCE-1 filers with one receiving over 20 such filings. However, since that year, the number of these products dropped dramatically with only 2 in 2019 and none in both 2020 and 2021.

What is its significance?

It was surprising to see a hyper-competitive market appear over Orilissa. While we could attribute 2020-2021 as Covid-19 time with fewer ANDA filings in general, I am not so sure that you can draw that quick conclusion. After 2018, it appears that ANDA filers were beginning to be more selective in filings which could account for the significant drop over the last three years.

However, 9 filers fighting over a $139M product? Makes one wonder if there is something else going on. It appears to be a function of fewer good generic opportunities to develop. This conclusion makes you think that the PIV Market is at a nadir or at least a soft spot for now.