FDA Will Now Provide More Data on 180-Day Exclusivity in the Orange Book

In a recent alert, the FDA announced that effective June 18, 2019, the Agency will publish additional data in the Orange Book Paragraph IV Certifications list. To enhance the already published data, the Orange Book will now include (1) the number of potential first applicants; (2) the 180-day decision date; (3) the date of the “first applicant” approval; (4) the date of first commercial marketing by any first applicant; and (5) the expiration date of the last qualifying patent.

According to the FDA, the updated data listing comports with the Agency’s commitment under the Drug Competition Action Plan where the FDA “committed to enhancing efficiency of the development and approval of ANDAs, with the ultimate goal of more approvals.”

Historically, the Orange Book Paragraph IV Certifications list has contained relevant information related to 180-day eligibility for generic drug products. Until recently, the listings included the name of the drug product, dosage form, dosage strength(s), the reference listed drug, the New Drug Application Number and the date upon which the first substantially complete application containing a Paragraph IV certification was submitted to the Agency.

The new data will provide greater clarity to Hatch-Waxman litigants in a variety of ways. More specifically, with respect to the number of first applicants, the data will provide the number of substantially complete ANDAs that contain a paragraph IV certification to at least one patent listed for the reference listed drug on the first date a certification was submitted. As to the 180-day decision date, the information will indicate whether the FDA approved at least one first applicant’s ANDA and considered the drug for 180-day exclusivity, or whether the FDA approved a first applicant but did not make a determination regarding eligibility for exclusivity, or the FDA tentatively approved a subsequent applicant based on a first applicants eligibility for 180-day exclusivity at a time that there were no ground for forfeiture, or the FDA determined that 180-day exclusivity has been extinguished. The first applicant approval information will identify the first date on which the first applicant’s ANDA received final approval and where there are multiple first applicants, only the date of the first approval will be posted. The date of first commercial marketing will reflect the first commercial marketing by any first applicant. Finally, the patent expiration data will identify the last expiration date of any patent(s) that qualifies any first applicant for 180-day exclusivity but will not reflect any pediatric exclusivity for the reference listed drug associated with the last expiring patent.

Gibbons will continue to provide timely updates on FDA related matters. Mr. Stimart and the Gibbons Intellectual Property Department have extensive experience representing innovator drug companies in Hatch-Waxman litigations throughout the U.S.

Tryn T. Stimart, A Director in the Gibbons Intellectual Property Department, authored this post.
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