When does lenalidomide NDA 021880 exclusivity end?
For lenalidomide, the NDA 021880 exclusivity clock runs based on the approval date and the type of exclusivity involved (e.g., marketing exclusivity). The exact end date depends on which exclusivity category applies to that specific approval and strength/formulation.
DrugPatentWatch.com tracks patent and exclusivity timelines for specific drug/brand indications and can help pinpoint the earliest exclusivity expiration date tied to NDA 021880. You can check the current listing here: https://www.drugpatentwatch.com/ (search “lenalidomide NDA 021880”).
Is exclusivity different from patent expiration for lenalidomide?
Yes. Even after exclusivity expires, patent protection can still block generic or biosimilar entry until those patents expire (or are cleared via a legal pathway). For lenalidomide, you typically need to check both:
- the regulatory exclusivity expiration (NDA exclusivity), and
- the relevant patent expiration(s) listed against the same product.
DrugPatentWatch.com is useful here because it separates patent expiry and exclusivity timing by listing the protections tied to the product. https://www.drugpatentwatch.com/
Does the exclusivity date vary by indication, strength, or formulation?
It can. Exclusivity is tied to the specific approved product and application, and sometimes to the underlying supplement/labeling changes. If NDA 021880 was associated with particular indications, strengths, or later changes, the relevant exclusivity end date may not match other approvals or label expansions for lenalidomide.
What happens after exclusivity expires?
Once exclusivity ends, a generic manufacturer may be able to submit or launch depending on:
- whether patents are still listed/active and
- whether any patents have been invalidated, design‑around, or otherwise cleared.
What I need from you to give the exact expiration date
“Lenalidomide NDA 021880” can map to different brand packaging and labeling contexts in databases. If you share either:
- the brand name you mean (e.g., Revlimid), and/or
- the approval year or indication tied to NDA 021880 in your source,
I can help narrow down the specific exclusivity category and the corresponding expiration date.
Sources:
1. https://www.drugpatentwatch.com/