Big Change to the Orange Book

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) contained a provision that would change the NDAs for biological products to BLAs after the tenth anniversary of the BPCIA’s enactment. [See section 7002(e)(4) of the BPCIA]. Well, March 23 was that 10th anniversary! In honor of that event, the FDA deleted all of the biologic products that were listed in the Electronic Orange Book. Poof, gone! (Except, for some reason, Sanofi’s LANTUS and LANTUS SOLOSTAR (insulin glargine) products are still showing up in an EOB search for "insulin." I have a question about that pending with the Orange Book staff).

Also in honor of this event, the FDA issued a new version of Volume 40 of the Orange Book in PDF format. That new version, dated March 20, 2020, freezes in time all of the Orange Book listings that existed just days before the deletion of the biologic products. So if you want a snapshot of biologic products prior to the switch from NDA to BLA, you should download that new version of Volume 40.

Alternatively, I provided a direct and simple way to see the patents and exclusivities of just the deleted biologic products in my Orange Book Companion®. That information is found in a separate set of tables just for that purpose. Here is a sample table in which the deleted biologic products have a trademark that starts with “A.”

#patents #drugpatents #fda #fdaorangebook #orangebook #hatchwaxman #orangebookinsights #bpcia #biologics


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