The FDA’s Purple Book

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As we previously reported, the “Consolidated Appropriations Act” enacted in December of last year contained a provision that required FDA to create a searchable, electronic database of biologics and to update it with patent information provided to an applicant during the patent dance.  As of the effective date of June 25, 2021, the FDA’s Purple Book is now live, and provides a searchable database of licensed biological products, including the patent information provided by the Reference Product Sponsor to biosimilar applicants during the patent dance.   The Purple Book database currently lists patents for Humira, Avastin, and Lucentis.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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