What is the “Orange Book” and what does “36th edition” mean?
The “Orange Book” refers to the FDA’s publication Approved Drug Products with Therapeutic Equivalence Evaluations—commonly called the Orange Book. It lists approved drug products and assigns therapeutic equivalence ratings for approved active ingredients. The phrase “Orange Book 36 edition” means the specific version number of that FDA publication (the 36th published edition).
Where can I find the Orange Book 36th edition?
To locate the exact 36th edition, search the FDA’s Orange Book resources for the publication that corresponds to the “36th edition” release date/version. The FDA typically posts Orange Book editions and/or downloadable datasets tied to each edition.
Does “Orange Book 36 edition” affect generics and patent lookups?
Yes. The Orange Book is often used for patent and exclusivity lookups that relate to generic drug applications. When you reference a particular edition (like the 36th), the listings and patent/exclusivity entries you see are those included in that edition.
Are there patents/exclusivity listed that change between editions?
They can. New patents/exclusivity entries can be added, and some entries can be updated or removed as the underlying regulatory status changes. That means the Orange Book contents can differ across editions, so switching editions can change what patents/exclusivities you see for a given drug.
If you mean a specific drug’s Orange Book record: what should you tell me?
The Orange Book is searchable by drug name/active ingredient and strength/form. If you share:
1) the active ingredient or brand name, and
2) the dosage form/strength (if relevant),
I can help you interpret what the Orange Book lists for that product within the context of the edition you mean.
Sources
None provided in your prompt. If you share the FDA link or the drug name you’re looking up, I can target the right Orange Book edition and explain the record fields.