The FDA’s Purple Book

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.