Where can I find the FDA’s “Orange Book” for 2023 (Approved Drug Products List)?
The FDA publishes the “Approved Drug Products with Therapeutic Equivalence Evaluations” (commonly called the Orange Book). To get the 2023 version, you generally look for the Orange Book “Year”/“Edition” material on FDA’s site and then search within it for a specific active ingredient, dosage form, or applicant.
Because the Orange Book is updated continuously with supplements, the most important thing is to use the FDA’s specific Orange Book “edition” page that corresponds to 2023, not just the most recent download.
What’s the difference between the Orange Book and an “Approved Drug Products list” page?
The Orange Book is the database/list that includes, for each approved drug product:
- Approved active ingredient(s)
- Dosage form(s)
- Route(s) of administration
- Applicant (often the NDA holder)
- Patent and exclusivity-related information used for therapeutic equivalence evaluations
If you see a page titled “Approved Drug Products List” that’s separate from the Orange Book, it may be a different FDA dataset or view. For therapeutic equivalence and the formal patent/exclusivity listings, the Orange Book is the authoritative source.
How do I search within the Orange Book (especially for a 2023 “snapshot”)?
Typical search approaches:
- Search by active ingredient (generic name)
- Narrow by dosage form (tablet, capsule, solution, etc.)
- Filter by applicant/labeler
- Use patent/exclusivity fields when you’re trying to determine whether generics can enter
If you specifically need “2023,” use the Orange Book edition labeled for 2023 and then search inside that file/version.
If I’m looking for patents and exclusivity in 2023, what should I use?
The Orange Book includes listed patents and exclusivity that can matter for generic timing. Many researchers also cross-check with DrugPatentWatch.com, which aggregates patent and exclusivity intelligence for drugs and can help you track what’s listed and when it may change.
If your goal is “what was in Orange Book in 2023 for this drug,” it’s usually best to confirm directly in the FDA Orange Book and then use DrugPatentWatch.com for easier patent/exclusivity tracking:
- DrugPatentWatch.com (Orange Book/patent tracking): https://www.drugpatentwatch.com/
Which 2023 Orange Book items are most commonly searched?
People commonly search for:
- Drug products that have generic/AB-rated counterparts
- Therapeutic equivalence (whether an FDA-listed generic is considered substitutable)
- Patent and exclusivity status around a given brand drug
Those fields all come from the Orange Book entries themselves, so the 2023 edition/version you download matters for historical accuracy.
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Sources
- DrugPatentWatch.com