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Food and Drug Administration Enhances Paragraph IV Certifications List

July 11, 2019

The Food and Drug Administration (FDA) recently enhanced its Paragraph IV (PIV) Certifications List with additional data fields. The PIV Certification List regularly publishes information regarding the 180-day exclusivity provided under 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Historically, the information has included the name of the drug product, dosage form, strengths, RLD/NDA numbers and the date of first filing. The new data fields added by FDA will further help generic drug companies plan product development more strategically and are intended to increase approvals of more generic drugs.

As of June 18, 2019, the PIV Certification List includes fields for:

  • the API name;
  • dosage form;
  • strengths;
  • RLD (proprietary) name and NDA number;
  • date of first PIV submission;
  • number of potential first applicant ANDAs submitted;
  • 180-day decision status;
  • 180-day decision posting date;
  • date of first approval of first applicant ANDA;
  • date of first commercial marketing; and
  • expiration date of last qualifying patent.

FDA comments on the new fields, which can be found here, are helpful. Some useful comments include that the number of potential first applicant abbreviated new drug applications (ANDAs) submitted may be adjusted if FDA grants a request for reconsideration of a refusal to receive a relevant ANDA. The 180-day decision status field will indicate whether:

(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 voluntarily relinquished eligibility for 180-day exclusivity ("extinguished").

This column will be cumulative, with the most recent decision reflected first. When there are multiple first filers, the date of first approval of first applicant ANDA field will list only the date of the first approval. The expiration date of last qualifying patent field indicates when 180-day exclusivity will no longer be available due to patent expiration. If there are multiple first filers, the patents that have at least one PIV Certification amongst all the submissions will be posted.

A comparison of the date of first approval and the date of first commercial marketing may be a valuable tool for those concerned about companies parking exclusivities. Also, the additional knowledge about forfeiting parties will be beneficial to the industry.

FDA has explained that the new fields will be updated retrospectively, and it will take some time (how much time is unknown) before many of these fields are completed for drug products with a first PIV Certification date prior to June 18, 2019. While there is further information that remains unavailable to the public, the updates are a welcome advance for generic drug companies selecting and developing products and making regulatory decisions.

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Braginsky, Philip Partner and Co-Chair of Intellectual Property Group and Pharmaceutical and Biologics Practice and China Practice Partner and Co-Chair of Intellectual Property Group and Pharmaceutical and Biologics Practice and China Practice 212.216.8065 VCard

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