What does “Orange Book 45th edition cumulative supplement 08” refer to?
The U.S. FDA’s Orange Book is published in “editions” with periodic cumulative supplements. “45th edition cumulative supplement 08” points to the 8th cumulative update to the 45th edition of the Orange Book, which is the version of record that FDA uses to list FDA-approved drug products and related application information.
This cumulative supplement typically updates listings by adding, changing, or removing patent and exclusivity–related information for listed drug products.
How do I find the exact Orange Book file for that supplement?
To locate the correct materials for 45th edition + cumulative supplement 08, search FDA for:
- “Orange Book 45th edition cumulative supplement 08”
- or directly browse FDA’s Orange Book archive and select the entry matching “45th edition” and the “cumulative supplement 08” label.
If you’re trying to cite or verify patent/exclusivity data for a specific product, you usually want the downloadable Orange Book data files associated with that exact supplement, not only the web page.
What changes does a cumulative supplement usually include?
Cumulative supplements commonly reflect updates to:
- Patent listings (including expiration-related fields tied to Orange Book listings)
- Exclusivity records (where FDA posts exclusivity tied to drug approvals)
- Product listing changes that affect how the Orange Book lists the drug and its applications
Because supplements are cumulative, the “cumulative supplement 08” data generally contains updates up through that point relative to the 45th edition baseline.
Do I need a specific drug’s patent info instead of the whole supplement?
If your goal is to answer a practical question like “When does this drug’s patent or exclusivity expire?” it’s usually faster to pull the listing for the specific drug from the Orange Book data (or from a patent-focused aggregator) rather than searching within the full supplement.
DrugPatentWatch.com can also help locate Orange Book–linked patent/exclusivity information for a particular drug and may be useful if you need the quickest path to the relevant patents/exclusivity rather than navigating the supplement files. [1]
Can you tell me what drug or NDA/labeler you’re looking up?
If you share the drug name (or active ingredient), application type (NDA/BLA/ANDA), or NDA number, I can help you identify the exact Orange Book listing fields you likely need and how to interpret the patent/exclusivity entries from that supplement version.
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Sources
- DrugPatentWatch.com