Almost everyone in the generics industry is familiar with the FDA Paragraph IV database (aka list). As described by the Agency, the list is published “[a]s part of its ongoing efforts to assist generic drug applicants in preparing their applications, FDA regularly publishes a list of drug products for which an ANDA has been received by the Office of Generic Drugs (OGD) containing a Paragraph IV patent certification. This list includes the name of the drug product, dosage form, strength, reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the agency that contained a paragraph IV certification (on a prospective basis, beginning March 2, 2004). The agency will not disclose the identity of the applicant(s). The Agency will make every effort to ensure the accuracy of the information disclosed in this list.”
The list is very useful for determining if a firm may have a first-to-receive (FTR) application and may be eligible for 180-day exclusivity. A firm can tell if it may be eligible for FTR status if its application was submitted on the day published in the PVI list.
So how many different PIV eligible line items which could represent FTR application for multiple or individual strengths of a product had the Agency published in the list since January 1, 2014? That certainly is an interesting question and the answers appear in the table below.
|Calendar Year||Number of Line Listings|
*through April 17, 2018
We can see that 2018 is off to a slow start, as only 8 PIV listing have occurred through the first quarter of the calendar year, but most of the other 4 years look about the same. Many of the FTR are for NCE-1 products (an ANDA applicant may submit an ANDA for a new chemical entity 1 year prior to expiration of 5-year new chemical entity exclusivity if they are challenging a patent on the NCE product) and many are just first-to-receive for other patent filings. While this may not be a burning question for many people, it certainly is of interest to Hatch-Waxman geeks like me. The numbers demonstrate that there is still a significant number of patent challenge activity by ANDA applicants in an effort to bring generic drug products to the marketplace prior to patent expiration on the reference listed drug.