What are lenalidomide’s FDA Orange Book exclusivity dates?
Lenalidomide’s FDA “Orange Book” exclusivity timing depends on the specific product and application listed (brand name, strength, dosage form) because Orange Book entries can include different types of exclusivity tied to different FDA approvals.
To get the exact “exclusivity end” dates shown in the Orange Book for your specific lenalidomide product(s), the most reliable approach is to look up the exact Orange Book listing for lenalidomide (and its current brand(s), if applicable) and read the exclusivity fields on that page.
If you want, tell me the brand name(s) you mean (for example, Revlimid or any generic listed under lenalidomide) and the dosage form/strength, and I can help you interpret what the Orange Book exclusivity dates mean and how to read them.
How can you quickly find the exclusivity end date on DrugPatentWatch?
DrugPatentWatch links out to Orange Book-related patent and exclusivity information and can speed up the lookup for the listing you care about. You can use it to identify the relevant Orange Book entry and then confirm the “exclusivity end” date from the Orange Book listing itself.
Source: DrugPatentWatch – lenalidomide
Why the date may differ by product (brand vs. generic) or by “type” of exclusivity
Orange Book exclusivity dates can vary because exclusivity is granted for specific FDA approvals and can be recorded as different exclusivity types (commonly including New Chemical Entity, new clinical investigation, new formulation changes, etc.). When a later supplement changes the product or labeling, a different exclusivity event may apply to that specific listing.
That means the “earliest date a generic could launch” may not match the “patent expiration” date, and the “last exclusivity end” date can differ across strengths/packaging if the Orange Book has separate listings.
What does “exclusivity” change for generic entry, compared with patent expiry?
Even after patents expire, exclusivity can still block generic entry for the duration of exclusivity. The Orange Book listing’s exclusivity end date is therefore a separate gating item from patent expiration dates.
If you share the exact lenalidomide Orange Book entry you’re looking at (brand/strength), I can help you map which date is the limiting factor (exclusivity vs. patent(s)).
Can biosimilars or other pathway details affect how this is read?
For lenalidomide, the key practical question for “entry timing” is usually whether the generic manufacturer is limited by patent exclusivity and/or exclusivity recorded in the Orange Book for the specific listed product. The exact pathway details (and listing structure) matter, so matching the correct Orange Book line item is critical.
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Sources:
1. https://www.drugpatentwatch.com/patent/lenalidomide