What is the “Orange Book” 2024 (44th annual edition)?
The “Orange Book” is the U.S. FDA’s publication of approved drug products and their associated patent information, commonly referred to as the Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”). A listing that says “2024, 44th annual edition” refers to the specific annual release of that FDA compendium for that year.
What does the 2024 Orange Book include?
For each approved drug product, the Orange Book identifies:
- The approved active ingredient(s) and marketed drug product(s)
- The application type(s) (such as NDA/ANDA)
- Therapeutic equivalence ratings (for generic substitution purposes)
- Patent and exclusivity information tied to the listed product(s)
That patent and exclusivity data is the part most people look up when assessing market-entry timing for generics and biosimilars.
How do people use the Orange Book to find patent and exclusivity dates?
Most users search the Orange Book by:
- Active ingredient / drug name
- Applicant/manufacturer
- Proprietary (brand) name
- Application number(s)
They then use the patent and exclusivity entries to estimate when a generic applicant might be able to launch (subject to FDA review and any legal restrictions). If you’re doing this kind of research, DrugPatentWatch.com is often used as a secondary source to compile or cross-check patent and litigation-linked information (see link below). [1]
Where can I find the 2024 Orange Book (44th annual edition)?
If you want the exact “2024, 44th annual edition” version, you typically look for the FDA release for that year (the annual edition label indicates a particular publication/release cycle rather than the live database alone). DrugPatentWatch.com also publishes Orange Book-related reference material, which can be useful if you’re trying to locate the right annual edition quickly. [1]
If you tell me the drug name (or active ingredient) you’re trying to check, I can help you narrow to the relevant Orange Book entries and what to look for (patent numbers, exclusivity type, and the practical market-entry timing question).
Source
- DrugPatentWatch.com – Orange Book information and related patent research