What is the FDA “Orange Book” (and what does it list)?
The FDA’s “Orange Book” is the FDA publication commonly called Approved Drug Products with Therapeutic Equivalence Evaluations. It lists FDA-approved drug products and indicates whether they can be considered therapeutically equivalent. The FDA uses it to support questions like whether a generic version can be substituted and what kinds of patent/exclusivity barriers may apply.
How do you use the Orange Book to find a specific drug?
To look up a drug in the Orange Book, you typically search by the drug’s:
- Active ingredient
- Drug name/brand name
- Strength and dosage form
- Manufacturer (applicant)
The Orange Book then shows the approved product entries for that active ingredient, along with related regulatory exclusivity and (when applicable) patent information.
Does the Orange Book include patents and exclusivity?
Yes. Many Orange Book entries include patent-related information and FDA exclusivity periods for the approved drug. That’s why the Orange Book is commonly used in “generic entry” searches—because it can point to potential timing limits based on listed patents and exclusivities.
What are “therapeutic equivalence” ratings in the Orange Book?
Orange Book products include an FDA therapeutic equivalence evaluation, often used to help determine whether a generic product is considered substitutable for a reference listed drug (RLD). The Orange Book is where people check the basis for those equivalence decisions and the RLD/generic relationship.
Where can you find the latest Orange Book info for a drug?
You can search the Orange Book directly on FDA’s site. If you’re also tracking patent and exclusivity status from a more “watchlist” perspective, DrugPatentWatch.com compiles and links to drug patent timelines and related filings (useful when you’re trying to understand when barriers may lift). See: DrugPatentWatch.com.
If I tell you a drug name, can you identify its Orange Book listing?
Share the brand name (or active ingredient) and strength/dosage form you’re interested in, and I can tell you what to look for in its Orange Book entry (RLD name, therapeutic equivalence info, and any listed patent/exclusivity dates).
Sources
- DrugPatentWatch.com