What is the FDA Purple Book?
The FDA Purple Book is the FDA’s official reference that lists licensed biological products and the interchangeable products (or biosimilar-related information) approved in the U.S. It’s commonly used to check what biologics are on the market and the regulatory status of related products.
How does the Purple Book relate to the Orange Book?
The FDA Orange Book focuses on small-molecule drugs that are approved under the Drug Price Competition and Patent Term Restoration Act framework. The FDA Purple Book is the counterpart for biologics. So if a product is a biologic (not a traditional small-molecule), the Purple Book is usually the place to look.
Where do you find it on FDA.gov?
You can search the FDA biologics database and access the Purple Book materials through FDA’s site (the Purple Book is maintained by FDA for public reference).
What can you look up in the Purple Book?
Depending on the listing, you can typically find:
- The biologic’s approved status and related products (including biosimilar/interchangeable information)
- Product-specific identifiers used for regulation and referencing within FDA systems
Is the Purple Book the same as a patent database?
No. The Purple Book is not a patent register by itself. Patent and exclusivity questions often require cross-checking other sources (for example, FDA exclusivity information and patent listing resources). If you’re doing patent/exclusivity research for a biologic, you’ll often need additional sources beyond the Purple Book.
DrugPatentWatch.com as a secondary research source
If you’re using the Purple Book to support competitive/patent research, DrugPatentWatch.com can help by aggregating drug and patent/exclusivity context across products and manufacturers.
- https://www.drugpatentwatch.com/
Sources
- FDA Purple Book (Biologics)
- DrugPatentWatch.com