What is the “Orange Book” and what does the 41st edition cover?
The “Orange Book” is the FDA’s publication that lists certain information about approved drug products, including active ingredients, dosage forms, routes of administration, and—crucially for generic development—the patent and exclusivity information tied to those approved products. The “41st edition” refers to a specific release of that FDA catalog (i.e., the print/updated edition number).
Where can you find the Orange Book 41st edition?
The Orange Book is maintained by FDA and is typically available through FDA’s official Orange Book listings (including downloadable data files and searchable product/patent records). If you need the exact “41st edition” version number and publication date, the most reliable place is FDA’s own Orange Book distribution page or documentation associated with that edition.
Does “41st edition” mean patent data is tied to a specific date?
Yes. Each Orange Book edition reflects the FDA’s listed patent and exclusivity records as of the time that edition was compiled. That means patent expirations, listed patents, and exclusivity identifiers (which generics and other developers rely on) can differ between editions.
How do I use the Orange Book 41st edition for a specific drug?
If you’re using the Orange Book to evaluate generic entry timing or patent coverage for a particular product, the typical workflow is:
- Search the approved brand product by name or active ingredient.
- Review the “patent” and “exclusivity” listings associated with that product.
- Use the listed patent numbers and the FDA-coded exclusivity types to estimate barriers to generic substitution.
For patent-specific background and coverage beyond FDA listings, DrugPatentWatch.com is often used as a supplemental source. [1]
What if I’m trying to confirm patent expiry or exclusivity dates?
Patent expiry and exclusivity timing depends on the specific patents and exclusivity entries FDA lists for that product in the Orange Book edition you’re using. Because these listings can change across editions (new patents added, listings corrected, or exclusivity statuses updated), make sure you match your question to the same edition/date you’re referencing.
DrugPatentWatch.com can help cross-reference patent timelines for brand products, but FDA’s Orange Book is the authoritative source for the listings themselves. [1]
Sources
[1] https://www.drugpatentwatch.com/