As you may be aware, the Food and Drug Administration (“FDA”) regularly publishes a list of drug products for which one or more substantially complete abbreviated new drug applications (“ANDAs”) containing a Paragraph IV (“PIV”) patent certification have been submitted to FDA. This list is a useful resource for both generics considering the filing of an ANDA, as well as innovator companies evaluating the market, potential litigation, and settlement possibilities. Until very recently, however, this list only included 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) that contained a PIV patent certification was submitted to the FDA.
Beginning on June 18, 2019, as part of its initiative to enhance efficiency in the development and approval of ANDAs, the FDA has begun to include a number of additional categories of information about each drug product to its Paragraph IV Certifications List, described in more detail below. This new information will be added for all newly listed drug products, and also retrospectively as practicable for previously listed entries as the list gets updated.
The new Paragraph IV Certifications List, which may be directly accessed from the FDA at https://www.fda.gov/media/82686/download (currently updated as of July 16, 2019), contains the above mentioned previously included information, as well as the following new categories:
- Number of Potential First Applicant ANDAs Submitted – this may be adjusted over time (i.e., if the FDA grants a request for a reconsideration of a refusal to receive a relevant ANDA).
- 180-Day Decision Status – generally includes one of four possible indications regarding whether the FDA has made (or has deferred) a decision regarding eligibility for 180-day exclusivity for a drug product: eligible, deferred, non-forfeiture, or extinguished.
- “Eligible” indicates at least one first applicant has been deemed eligible for 180-day exclusivity at the time of approval.
- “Deferred” indicates the FDA approved a first applicant, but did not make a determination regarding eligibility for exclusivity at the time of approval.
- “Non-forfeiture” indicates the 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.
- “Extinguished” indicates the FDA determined that 180-day exclusivity has been extinguished, such as in the case all first applicants have forfeited or voluntary relinquished eligibility for 180-day exclusivity.
- These categories may be amended, such as if there is a later failure-to-market or other forfeiture, or may be blank if the FDA has not yet made any such determination. The failure-to-market forfeiture provisions are of critical importance to innovators and generics alike. For a convenient tool to understand and apply them, download our free FTM Forfeiture app (available here), which asks a series of questions and shows whether a forfeiture has occurred, with the statutory language highlighted to explain.
- 180-Day Decision Posting Date – this column reflects the month and year of the most recent decision by the FDA for the preceding column. As the PIV Certification List has only just begun to include this information, however, for older drug products this will simply reference the first time such information is included in the list (June 18, 2019 or later), rather than reflecting the date the FDA had actually originally made the identified decision.
- Date of First Approval of “First Applicant” ANDA – this entry provides the first date on which a first applicant’s ANDA received final approval, listing only the first approval even if there are multiple first applicants.
- Date of First Commercial Marketing – provides the date of first commercial marketing by any first applicant, if any.
- Expiration Date of Last Qualifying Patent – this column lists the last expiration date of any patent(s) that qualifies any first applicant for 180-day exclusivity for a given drug product. To the extent there are multiple first applicants challenging different patents, the date shown will be the expiration date that is last-in-time for a patent for which a PIV certification has been submitted by at least one of those first applicants. As such, this entry provides when 180-day exclusivity will no longer be available due to patent expiry. This column does not reflect any pediatric exclusivity for the RLD associated with the last qualifying patent.
As noted above, these newly added columns are being updated retrospectively. Entries for drug products that reflect a date of first PIV certification prior to June 18, 2019 may, thus, remain blank for some time until the FDA is able to update the drug product’s information. Blank entries for drug products with first PIV certifications after June 18, 2019, however, will generally mean the FDA has not yet made a determination or an event has not yet occurred for that column.
We understand that generic drug manufacturers are already using the updated list as a reference in evaluating market potentials and resolution of litigation. As a result, the FDA’s Paragraph IV Patent Certifications List is an important resource for innovator companies, as well as other companies focused on the life sciences, when evaluating litigation, settlement, and due diligence positions.