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4 New Paragraph IV Certifications Listed by FDA

Everyone associated with generic drug submission realizes that generic companies that want to market a copy of a drug product prior to the expiration of a patent must file a patent challenge to existing patents (a so-called Paragraph IV [“PIV”] challenge).  FDA updates its list of PIV submissions so other firms will know the date of a first filer.  FDA began publishing its PIV database to alert firms that a substantially complete application had been filed and the date of the filing. They don’t say who it was or how many applicants were filed on that date, but ANDA applicants know by the date if they are potentially eligible for first filer status.

Prior to publishing the list, OGD used to get a significant number of calls from firms to see if they were the first filer and they did not always tell the applicant.  OGD decided that the PIV database was the best way to make this information available to the public, reduce the number of calls to them asking this question, and provide everyone with the same timely information necessary to determine if they were a first filer (remember, particularly for NCE-1 products [i.e., subject to 5-year New Chemical Entity], an ANDA applicant can file an ANDA with a PIV certification challenging one or more of the patents one year before the expiration of the NCE expiration date).  So, for NCE-1 products, we usually see first filers on the 4-year anniversary of the 5 years NCE period.

Such is the case for one of the products (Tasimelteon capsules) in this current update to the PIV database (here).  The other three are copies of non-NCE drugs that have patents that are being challenged.  It could be coincidence that there are multiple first filers for these products but more unlikely because for an NCE product there is a date certain where one would expect a first filer.

The new entries appear in the table below.

 

The database for most prior PIV certifications and the first filer date of submission also appear on the webpage cited above.  The list is 63 pages long and sorted alphabetically by drug name.  This is a good resource that provides critical information on PIV certifications as they relate to potential first filer status.