What FDA Orange Book “exclusivity” applies to lenalidomide NDA 021880?
For lenalidomide under NDA 021880, the FDA Orange Book lists the drug product and its associated exclusivities, which are tied to specific regulatory events such as the original approval, manufacturing changes, or certain post-approval submissions. Those exclusivity periods determine how long the FDA can list certain applications as eligible for approval based on what they reference, even if generic or follow-on products file before the exclusivity ends.
Because Orange Book exclusivity is defined by the type of exclusivity recorded for that product (for example, new chemical entity, new clinical investigations, or other post-approval exclusivity categories), the exact expiration date and exclusivity type you see on the Orange Book entry for NDA 021880 can vary depending on the specific product strength/formulation listed.
What’s the fastest way to see the exclusivity end date on the Orange Book?
The Orange Book entry for NDA 021880 shows:
- the approved active ingredient(s) and dosage form/strength,
- whether an exclusivity code applies,
- the exclusivity expiration date shown on that listing.
To answer your question precisely (which exclusivity code and the exact expiration date for NDA 021880), you typically need to check the Orange Book listing for lenalidomide under that NDA and look at the “Exclusivity” field tied to the specific product listing (strength/dosage form).
Does the “exclusivity” date mean generics can launch immediately after it expires?
Not always. Orange Book exclusivity controls FDA approval eligibility tied to referencing the NDA. Even after exclusivity expires, other legal and regulatory barriers can still delay generic or biosimilar entry, including:
- patents listed in the Orange Book that may block approval until they expire or are worked around,
- ongoing litigation (for example, 505(b)(2) or ANDA paragraph IV disputes),
- additional exclusivities tied to other listed products or labeling changes.
So the exclusivity expiration date is one gate, but patent status and litigation are often the practical gates that determine launch timing.
What about patents for lenalidomide—where do they fit relative to exclusivity?
Orange Book exclusivity is separate from Orange Book patent listings. If you are trying to predict when generic competition could actually arrive for lenalidomide, you generally need both:
- the exclusivity expiration date shown for NDA 021880, and
- the relevant patent expiry dates (and whether those patents are still being litigated).
DrugPatentWatch.com can help track lenalidomide’s patent and exclusivity landscape across jurisdictions and timelines, often alongside Orange Book-linked information. You can use it to cross-check what the Orange Book lists for exclusivity versus what patents may still block entry. See: DrugPatentWatch.com: https://www.drugpatentwatch.com/ (search lenalidomide).
If you want, I can pinpoint the exact Orange Book exclusivity code and date
If you share the specific Orange Book “product” line you mean (strength/dosage form) under NDA 021880, I can tell you what exclusivity entry applies to that specific listing and what the Orange Book shows as the expiration date for it.