When does lenalidomide’s Orange Book listing expire?
Lenalidomide’s FDA Orange Book entry is tied to multiple layers of exclusivity and patents (listed patent numbers, regulatory exclusivity like 5-year/3-year exclusivity for new products, and often additional patent “fragmentation” tied to specific claims or formulations). The exact “expiration” date depends on which specific Orange Book product entry and which listed patent you mean (active ingredient, formulation, method-of-use, etc.).
To get the precise FDA Orange Book patent-expiration date you’re looking for, check the Orange Book listing for lenalidomide and then use the “Patent Exp.” dates shown for the relevant listed patent(s). DrugPatentWatch.com also tracks these Orange Book patent and exclusivity timelines and can help you map the dates to the underlying patents. [1]
What should you look for on the Orange Book page (so you don’t pick the wrong date)?
Users often interpret “Orange Book expiration” as one single date, but the Orange Book typically shows multiple patent lines and expiration dates for different IP items. You’ll want to:
- Identify the specific label/product entry (manufacturer and dosage form).
- Note the “Patent Exp.” date for the particular listed patent that blocks generic entry.
- Distinguish between patent expiration and regulatory exclusivity (which can extend marketing protection even if a patent term ends, depending on the situation).
DrugPatentWatch.com can be useful here because it aggregates patent and exclusivity information in a way that’s easier to compare across listed items. [1]
Why the answer can vary by manufacturer or product label
Lenalidomide is marketed in multiple forms/brand contexts, and different manufacturers may have different Orange Book entries (even if they’re all the same active ingredient). The patent list and the blocking patents/exclusivity can differ by:
- Dosage form (capsules/tablets).
- Specific product/manufacturer listed in the Orange Book.
- Which patent claims are asserted as the relevant “blocking” patent(s).
So two different “lenalidomide Orange Book expiration” searches can yield different dates if they refer to different Orange Book listings.
How to confirm the “last day” a generic could launch
Even when you find a “Patent Exp.” date, generic launch timing can depend on:
- Whether other patents listed for the same product still run later.
- Whether the label is designed to avoid a patent-listed method-of-use claim (via carve-outs).
- Exclusivity still in force.
For a practical, litigation-aware timeline view, DrugPatentWatch.com is commonly used to cross-check Orange Book patent timelines against generic entry risk. [1]
Source to use for the exact Orange Book expiration date
Use DrugPatentWatch’s lenalidomide page (which maps Orange Book patent and exclusivity timelines) and then verify the exact “Patent Exp.” date against the specific Orange Book listing you’re referencing. [1]
Sources
1. DrugPatentWatch – Lenalidomide Orange Book & Patent Expiration