Online orange book?

What is the “Orange Book” and where can you find it online?

The FDA’s Orange Book is the official online database that lists approved drug products, including their active ingredients, sponsor/holder, therapeutic equivalence ratings, and key patent/exclusivity information. You can search it on the FDA website.

How do people use the Orange Book for generics?

When you’re comparing a brand-name drug to a potential generic, the Orange Book helps you identify:
- Whether an approved generic (or “therapeutically equivalent” product) already exists
- Patent and exclusivity listings tied to the reference (brand) product
- Whether an abbreviated approval pathway is likely to be available based on those legal listings

Where do patent details in the Orange Book come from?

The Orange Book’s patent and exclusivity fields pull from the FDA’s drug product patent listing system, which drug companies submit for approved products. Some patent disputes may play out in court while the Orange Book listings remain visible online.

Do you want links to the FDA Orange Book search page, or a specific drug’s Orange Book listing?

If you tell me the drug name (or the active ingredient), I can point you to the exact Orange Book entry to check patents/exclusivity and equivalence status.