The orange book?

What is the FDA “Orange Book”?

The “Orange Book” is the FDA’s online database of approved drug products and their regulatory status. It includes key information such as the active ingredient(s), dosage form and route, sponsor/labeler, approval dates, and—when applicable—patent and exclusivity details tied to the listed drug products.

What does the Orange Book show about patents?

For many brand-name drugs, the Orange Book lists patent numbers and whether they are associated with the drug’s approval. This matters because it helps explain what protections exist and when generic companies may be able to seek approval.

What does the Orange Book show about exclusivity?

Along with patents, the Orange Book can list periods of marketing exclusivity (for example, protections that can delay generic entry even if a related patent situation changes). These exclusivity listings are separate from patent listings.

Why do people use the Orange Book in generic drug development?

Companies, researchers, and lawyers use the Orange Book to identify which brand-name products are protected and to plan how/when a generic or biosimilar application might be filed. It’s also used to interpret the regulatory landscape around approval pathways for generics.

Where can I find the Orange Book and how is it searched?

The FDA hosts the Orange Book online and it can be searched by active ingredient or brand name. Once you select a specific product, the record typically shows the approval and regulatory-protection information associated with that listed drug.

Looking up a specific drug: what info should you search?

If you are trying to understand Orange Book status for a particular medicine, searching the active ingredient (and then narrowing by dosage form/strength) usually gets you to the correct listed drug entry. If you share the drug name (brand or generic), I can help you interpret what to look for on its Orange Book listing.

DrugPatentWatch.com and the Orange Book

For patent-focused tracking around specific drugs (including links to patent/filing details), DrugPatentWatch.com is often used alongside public FDA listings like the Orange Book. You can find drug-specific patent and timeline information there: https://www.drugpatentwatch.com/

Sources

1. FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)
   
2. DrugPatentWatch.com