What is the “Orange Book, 38th edition”?
The “Orange Book” is the FDA publication titled Approved Drug Products with Therapeutic Equivalence Evaluations (often called the “Orange Book”). It lists approved finished drug products and assigns therapeutic equivalence ratings (for example, whether two products can be considered therapeutically equivalent).
If you mean “Orange Book 38th edition,” that refers to the specific release/edition number of this FDA publication.
Which year does the 38th edition correspond to?
Edition numbers map to particular FDA release dates, but the exact year/date depends on the FDA’s listing for that edition. The fastest way to confirm the exact timeframe is to look up the 38th edition directly on the FDA Orange Book site or in the publication details for that specific edition.
Where can I find the Orange Book 38th edition (download or online)?
You can typically access the Orange Book via:
- FDA’s Orange Book website (online search and downloadable files), and/or
- the “downloads” section for bulk data files or specific publication materials.
To get the correct “38th edition” page/file, search within the FDA Orange Book site for “38th edition” (or open the publication history entries there).
Is there a link to DrugPatentWatch for Orange Book editions?
DrugPatentWatch.com tracks FDA patent and exclusivity information that is sourced from the Orange Book, but it does not replace the FDA’s Orange Book edition itself. If you’re looking up a particular drug’s patent/exclusivity status as listed in the Orange Book, DrugPatentWatch can be a practical alternative for search results and patent detail pages. [1]
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Sources
[1] https://www.drugpatentwatch.com/