On June 18, 2019, FDA posted its PIV List with some major revisions and additional data fields. Over the past 20 years, FDA has maintained the same format with basic information including the drug name (generic and branded trade name), dosage form, and strength. If memory serves me well, around 2004, it added the Date of First Filing.
Of course, researching ANDA filings, Paragraph IV certifications, and subsequent court cases can be challenging. As ANDA’s are kept confidential at FDA and the time to approval can be lengthy, there is a great deal of data that are unknown. The FDA List offered little to answer questions we would all like to know: how many filers are there on a particular product? Who might be first to file? Are there multiple first-filers?
The reality of this research is that it is a lot like piecing together a puzzle without having access to all of the pieces. While a few pieces may be enough to provide an accurate picture of how and when the generic market will emerge and what the competitive landscape will look like, having more pieces of data is always instructive.
The June 18 FDA List offers some additional data fields which help to answer some of these questions and put together a clearer picture of how the generic market will emerge. The FDA List has created new data fields including: Number of Potential First Applicants, 180-day Decision Status, Date of First Commercial Marketing, and Expiration Date of Last Qualifying Patent among others. It provides some explanation on its landing page of how it defines each of these fields, how they are revised, and when they may be updated.
For researchers and practitioners in this field, this is certainly helpful information and welcome revisions to the FDA List. We should applaud FDA for making additional information available that creates more transparency and informs business decisions.
However, it’s not like all of your questions might be answered. Just about all of the new data fields in the June 18 List are empty. FDA will fill these over time and have left room for revising numbers and dates as well. While a few completed fields are from prior activity (for example, it tells us there were 25 first filers for Eliquis®(apixaban) back in 2016), it appears the new additions will be “looking forward” and filled over time. Just a guess here, but it will take months, and maybe years, before the List becomes substantially robust.
Moreover, while FDA is offering a few more pieces to the puzzle, it cannot provide everything, and the FDA PIV List will continue to have its limitations. People in our industry will still need additional information to understand how generic markets will emerge and make informed business decisions. Data such as company statements, public disclosures, Paragraph IV court cases, Inter Partes Review proceedings, other public filings, and intra-company interactions with FDA will still have their place as additional pieces to the puzzle.
Here is a link to the FDA PIV List landing page: