Go for It! (Connect) Paragraph IV! FDA Revamps ANDA Paragraph IV Certifications List

The Paragraph IV certification list on FDA’s website is a very useful tool for generic drug manufacturers in evaluating the potential for 180 day exclusivity for any given product. The list generally describes drug products for which one or more substantially complete ANDA containing a paragraph IV certification has been submitted to FDA. As a generic sponsor, the list helps sponsors assess whether they are a first-filer, or whether they may be blocked by a first-filer after approval. It also tells you whether a first-filer has already been established, which helps determine whether it is worth investing resources to submit a Paragraph IV certification.

Up until June 18, 2019, the Paragraph IV certification list contained limited information. Specifically, the list included only the name of the drug product, dosage form, strength(s), reference listed drug (RLD)/new drug application (NDA) number, and the date on which the first substantially complete ANDA(s) (or amendment or supplement to one) was submitted to the Agency that contained a paragraph IV certification to at least one patent listed for the RLD in the Orange Book. But, as an element of the Drug Competition Action Plan, FDA updated this listtoday in an effort to “provide greater clarity to ANDA applicants regarding the earliest date when they may be able to obtain final approval.” To this end, FDA now plans to include the following information for individual drug products on the Paragraph IV certification list:

  • Active Ingredient Name
  • Dosage Form
  • Strength
  • RLD Name and NDA Number
  • Date of First Substantially Complete ANDA Containing PIV Submission
  • Number of Potential First Applicant ANDAs Submitted
  • 180-Day Decision Status (whether FDA has made a decision regarding eligibility for 180-day exclusivity for a drug product)
  • 180-Day Decision Posting Date (the month and year that FDA updated the PIV Certification List to reflect the corresponding 180-day decision status)
  • Date of First Approval of “First Applicant” ANDA(the first date on which a first applicant’s ANDA received final approval)
  • Date of First Commercial Marketing; and
  • Expiration Date of Last Qualifying Patent(if there are multiple applications submitted on the first day, the patents that have at least one PIV certification amongst all the submissions will be posted)

As of now, FDA intends to update the retrospectively “as practicable,” but this is a pretty big undertaking. In general, the information added here represents a pretty significant overhaul to the Paragraph IV certifications page.

The data points added to the Paragraph IV list are intended to provide information to enable generic sponsors to make better decisions. FDA explains that

With the update today, this new data may allow generic applicants to make more informed business decisions about which of their specific generic drug applications have a higher likelihood of being approved sooner. This data may also provide more public transparency into instances in which the FDA approves an ANDA with exclusivity, but the generic product is not marketed for an extended time which among other reasons may signal “gaming” tactics in the generic market.

And indeed this information can be very useful. For example, knowing that a product already has a first-filer will help sponsors determine whether it is worth commencing a patent challenge for a given product. Additionally, knowing that FDA has made an exclusivity determination already – and the date of that first-filer’s ANDA submission – is helpful to knowing where your application stands in the pack. As FDA explains, from this information alone, one can deduce that (1) FDA approved at least one first applicant’s ANDA and considered that first applicant’s drug product eligible for 180-day exclusivity at the time of approval (“eligible”); (2) FDA approved a first applicant but did not make a determination regarding eligibility for exclusivity at the time of approval (“deferred”); (3) FDA tentatively approved a subsequent applicant solely on the basis of a first applicant’s eligibility for 180-day exclusivity at a time that none of the grounds for forfeiture were found to apply (“non-forfeiture”); or (4) FDA determined that 180-day exclusivity has been extinguished, for example, if all first applicants have forfeited or voluntary relinquished eligibility for 180-day exclusivity (“extinguished”). Of course, not all 180-day exclusivity determinations will be included in the Paragraph IV certification list because of FDA’s practice to make certain forfeiture decisions in the context of specific ANDAs that are otherwise eligible for approval. So don’t expect any early forfeiture decisions here. But it is helpful nonetheless to know if a competitor with first-filer status is the subject of an exclusivity determination.

Additionally, the first commercial marketing date is helpful for subsequent applicants to know when they will be permitted to launch. Because 180-day exclusivity is triggered at commercial launch, which is typically not the same day as approval, there may be a question about the exact date that exclusivity ends. This information in the Paragraph IV certification list addresses that issue. (Of note, though, these products can be identified by a “Patent Challenge” (PC) code in the Exclusivity Data section of the Orange Book.) Further, the addition of patent expiration dates may be helpful in knowing whether 180-day exclusivity will continue to be an issue for later filers. This is because, upon expiration of the patent with a Paragraph IV certification results in 180-day exclusivity forfeiture. But because it’s not always possible to know which patents have been the subject of a Paragraph IV certification, including this information in the Paragraph IV list will help other potential applicants know when the potential for any 180-day exclusivity to run has expired.

While this information may not be groundbreaking, as much of it can be deduced for individual products if you know what you’re looking for, having it all in one place is and easily accessible is very helpful for sponsors. And it’s always a good thing when an agency not exactly known for transparency takes the initiative to make a complicated process easier on industry.