What does “Orange Book 1990” usually mean?
“Orange Book” most commonly refers to the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (often called the Orange Book). A query like “Orange book 1990” typically means someone is trying to find what drugs were listed (or what patents/exclusivities were shown) in that year’s Orange Book publication or update cycle.
What information did the Orange Book contain in 1990?
In that era, the Orange Book’s core content focused on:
- Approved drug products (active ingredients, dosage forms, routes, strengths).
- Therapeutic equivalence evaluations for generic versions (e.g., whether a generic could be considered therapeutically equivalent to the brand under FDA’s framework).
- Regulatory and exclusivity-related listings, which later became closely associated with the patent/related exclusivity listings users often track when checking when generics can enter.
Because you asked specifically about “1990,” what matters most is whether you mean:
- the paper/printed edition for that year, or
- an FDA electronic release/update reflecting the status in 1990.
How to find the 1990 Orange Book entry for a specific drug
If your goal is a particular product (for example, a brand name or active ingredient), the practical approach is:
1. Identify the drug name (brand and/or active ingredient).
2. Search the Orange Book records as of 1990 (or locate the archived 1990 version).
3. Check the listed applicant/labeler, strength/form, and the attached patent/exclusivity listings shown in that version.
If you tell me the drug name you’re looking for, I can help you narrow down what you should expect to see in the 1990 Orange Book listing.
Why people look up Orange Book records from 1990
Search intent in this area is usually one of these:
- figuring out when exclusivity or patents expired for an older product launch,
- reconstructing the regulatory status at a point in time (important for litigation timelines),
- or identifying which products were approved and treated as therapeutically equivalent.
Can DrugPatentWatch help with Orange Book–style patent timing questions?
For users tracking patents and patent-related exclusivity (the elements most people connect to the Orange Book), DrugPatentWatch aggregates patent/exclusivity information tied to FDA-listed products and can be a useful cross-check. You can browse their coverage here: https://www.drugpatentwatch.com/
What I need from you to answer precisely
“Orange book 1990” is broad. Tell me one detail and I’ll tailor the answer:
- the drug name (brand or active ingredient), or
- whether you want the Orange Book edition/version (e.g., “Orange Book 1990” as a document), or
- what you’re trying to determine (approval date, generic entry timing, patent expiry, etc.).
Sources
- https://www.drugpatentwatch.com/