What is the Orange Book “patent expiration date” for lenalidomide?
Lenalidomide’s FDA Orange Book listings don’t have a single, universal “expiration date” because each branded product typically has multiple patent entries (covering drug substance, formulations, methods of use, and exclusivities) that expire on different dates. The exact date you need depends on which specific lenalidomide product (and strength/route) you mean and whether you’re looking for patent expiration or regulatory exclusivity end dates.
To get the correct date, you must check the Orange Book for the specific “active ingredient” listing of lenalidomide and then match the correct “product” and patent entry shown for that product.
How do I find the right expiration date in the Orange Book quickly?
In the Orange Book entry for lenalidomide, each row corresponds to a patent and shows key fields such as:
- the patent number
- the “expiration” date (or the relevant end date for that patent listing)
- the patent “type” (for example, drug substance, drug product, method of use)
- related exclusivity information (which is separate from patent expiration)
If you tell me the exact brand name you’re checking (for example, Revlimid or another labeled product) and the strength/route, I can help you interpret which specific row’s date is the one relevant for “generic entry” timing.
Is lenalidomide’s availability limited by patents or by exclusivity?
Orange Book timing typically reflects two different concepts:
- Patent expiration dates for listed patents.
- Regulatory exclusivity periods (which can delay approval of certain generics even after some patents expire, depending on the exclusivity type).
So even if you see a patent expiration date, you still need to check whether any exclusivity listed alongside that product runs longer.
Why can different “expiration dates” show up for the same drug?
Orange Book listings often include multiple patents for the same active ingredient and product, such as:
- patents covering the compound/drug substance
- patents covering the formulation or manufacturing process
- patents covering specific methods of use
Those different protections can expire on different schedules, which is why searches for “lenalidomide FDA Orange Book patent expiration date” often produce multiple dates rather than one.
Can you give a specific date without knowing the product?
Not reliably. Without the specific Orange Book product you’re referencing, any single “expiration date” answer risks being wrong because different branded products and different Orange Book patent listings can have different end dates.
If you share the brand name (and ideally the Orange Book product strength/route), I’ll point to the exact Orange Book patent entry you should use and the date shown there.
Sources
No sources were provided with your question, and I can’t verify Orange Book dates from memory with enough accuracy.