What are the “Purple Book” and “Orange Book” (and where does “AUTTP” fit in)?
The “Purple Book” and “Orange Book” are U.S. government databases that track different kinds of products used in healthcare.
- The “Orange Book” is the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations. It lists approved drugs and, for generic drug approval purposes, includes patent and exclusivity information reported to FDA.
- The “Purple Book” is the FDA’s database for biologics license application (BLA) products, including biosimilar and interchangeable biologics. It also includes references that help identify related products and (for interchangeable/biosimilar context) what therapies may be substitutable.
“AUTTP” isn’t a standard name I recognize for a specific FDA reference book/database. People sometimes use abbreviations informally, so the meaning can vary by context (for example, an internal program name, a regulatory shorthand, or a different government dataset). If you meant a specific FDA database or an acronym used in drug patent/exclusivity discussions, tell me what “AUTTP” stands for or where you saw it, and I can map it to the right resource.
How do they differ in what they track?
The key difference is product type:
- Orange Book: drugs (small molecules) approved under an NDA.
- Purple Book: biologics (often larger, complex therapies) approved under BLAs, plus biosimilar and interchangeable products.
Where does patent/exclusivity information show up?
If your question is really about patents and exclusivity:
- For traditional “drugs” listed in the Orange Book, patent and exclusivity information is central to how generics are evaluated.
- For biologics in the Purple Book, the tracking is oriented around biologic products, biosimilars, and interchangeability rather than using the exact same structure as the Orange Book.
What people usually search next
- “What does Purple Book interchangeability mean?”
- “Why does a product appear in Purple Book but not Orange Book?”
- “How do I find patent and exclusivity details for a product—Orange Book or Purple Book?”
Quick check so I can answer precisely
When you say “Purple and orange book auttp,” did you mean:
1) “Purple and Orange Book AND TTP” (and you’re asking how to find patent/exclusivity timing), or
2) “Purple and Orange Book” plus “AUTTP” as a third specific FDA database/acronym?
Reply with the full form of AUTTP (or paste the text you saw), and I’ll give you the exact meaning and the right links/resources.