What is “Orange Book 37th edition”?
The “Orange Book” is the FDA’s publication that lists approved drug products and certain patent and exclusivity information for those products. The “37th edition” refers to a specific release/printing number of that FDA compendium.
Where can I find the Orange Book 37th edition?
The Orange Book is maintained and updated by FDA. To locate the exact “37th edition,” you typically need to use FDA’s Orange Book publication/archive pages or documentation that identifies the edition number and release date. If you tell me the product name (or active ingredient), I can help you pinpoint the relevant page in the Orange Book and the associated patent/exclusivity entries.
Why edition numbers matter (patents and exclusivity records)
Edition changes can affect what appears in the book for a given drug product, including the status of listed patents and exclusivity. If you’re using the Orange Book 37th edition to support a regulatory or legal timeline, it helps to match the edition to the correct FDA update cycle.
How to use it for a specific drug (what to look for)
If you’re looking up a drug within the Orange Book, the key fields usually include:
- Applicant/holder and drug product details
- Active ingredient(s)
- Patent numbers listed for that product
- Patent expiration dates
- Exclusivity type and expiration (where applicable)
If you share which drug you mean, I can translate the Orange Book fields into what they imply for patent expiry or exclusivity.
Want the link or do you need a specific drug lookup?
Reply with either:
1) the drug’s name/active ingredient you care about, or
2) the exact FDA link you found that mentions “Orange Book 37th edition,”
and I’ll help you interpret it or find the right entry.