Purple Book

Key facts

Official name

Purple Book: Database of Licensed Biological Products

Maintained by

FDA

History

PDF lists from 2014; searchable online database since 2020

Covers

Biologics licensed under Sections 351(a) and 351(k) of the PHS Act

Codified by

Purple Book Continuity Act of 2020

What is the Purple Book?

The Purple Book is the biologics counterpart of the Orange Book. Where the Orange Book covers drugs approved under New Drug Applications and Abbreviated New Drug Applications, the Purple Book covers products licensed under a Biologics License Application (BLA), such as monoclonal antibodies and therapeutic proteins, along with products regulated by CBER.

The FDA first published the Purple Book as PDF lists in 2014 and replaced them with a searchable database in 2020. The Purple Book Continuity Act of 2020 wrote the list into the Public Health Service Act and required the FDA to publish patent lists that reference product sponsors share during biosimilar patent exchanges.

What the Purple Book lists

For each licensed product, the database shows:

• Proprietary and proper names, including any four-letter suffix on the proper name.
• BLA number, applicant, licensure date and marketing status.
• License type: reference product under Section 351(a), or biosimilar or interchangeable product under Section 351(k).
• The reference product each biosimilar was compared against.
• Reference product exclusivity and, where applicable, first interchangeable exclusivity dates.
• Patent lists, where a reference product sponsor has provided them.

Why the Purple Book matters

Biosimilar competition planning starts here. Licensure dates, exclusivity dates and the list of approved biosimilars for each reference product show how crowded a market is becoming and when new entrants can legally launch.

Approval does not equal launch. Patent settlements have delayed biosimilar entry for years in several major markets, so Purple Book data should be paired with launch announcements, NDC listings or claims data.

Purple Book vs Orange Book

The Purple Book carries no therapeutic equivalence codes; interchangeability is its closest equivalent. Its patent data come from lists exchanged under the Biologics Price Competition and Innovation Act (BPCIA) rather than routine listing by the sponsor, so many products show no patents at all even when patents exist.