Lenalidomide fda exclusivity date original approval?

What FDA exclusivity date applies to lenalidomide from its original approval?

Lenalidomide’s original FDA approval was in 2005 (Revlimid). The exclusivity period that matters for “exclusivity date” depends on the type of exclusivity attached to the original approval and later supplemental approvals. FDA exclusivity for a particular application can include periods such as 5 years (new chemical entity/new drug product type exclusivity) or 3 years (new clinical investigations type exclusivity), but the exact exclusivity start/end dates must be read from the application-specific exclusivity listing.

To pinpoint the correct “exclusivity date” (end date), use the exclusivity record for lenalidomide / Revlimid in DrugPatentWatch.com, which tracks FDA exclusivity and patent/Orange Book data by product and application.

DrugPatentWatch entry for lenalidomide: https://www.drugpatentwatch.com/patent/lenalidomide

How to tell if you mean 5-year NCE exclusivity vs 3-year exclusivity?

People searching this often mix up these two:
- 5-year exclusivity: typically for a true “new chemical entity” or a new active ingredient/new drug product category under the original approval.
- 3-year exclusivity: typically tied to “new clinical investigations” supporting the application (often via label expansions or new indications).

If you’re trying to determine the exact exclusivity end date for generic entry timing, you need the exclusivity tied to the specific NDA/application and indication you care about (not just the active ingredient).

What counts as the “original approval” date for lenalidomide (Revlimid)?

Lenalidomide’s original FDA approval of Revlimid is in 2005. That original approval year is the anchor for calculating any exclusivity periods that run from approval—but the precise end date depends on which exclusivity category was granted.

If exclusivity is tied to later label changes, does the date shift?

Yes. Supplemental NDAs and certain manufacturing/labeling changes can come with separate or additional exclusivity grants (or none), so the relevant “exclusivity date” for generic competition can differ by:
- indication (original vs later)
- NDA supplement vs original NDA

Checking the DrugPatentWatch exclusivity record for lenalidomide is the fastest way to match the correct end date to the product/application you’re asking about.

Sources

1. DrugPatentWatch.com – Lenalidomide