Lenalidomide fda original approval exclusivity date?

What was lenalidomide’s original FDA approval date?

Lenalidomide (Revlimid) received its FDA original approval on December 27, 2005. [1]

What exclusivity clock applies from that approval date (and what does “exclusivity” usually mean)?

When people ask for an “exclusivity date” tied to an FDA original approval, they usually mean one of these:
- U.S. patent exclusivity/litigation for the specific drug and indications (varies by patent and expires at different times).
- Regulatory exclusivity periods (for example, New Chemical Entity and other exclusivity types), which run from approval, but the exact type depends on the product’s regulatory history.

Because “exclusivity” can refer to different legal mechanisms, the most reliable way to get the exact “exclusivity date” for lenalidomide is to check the specific patent/exclusivity listings for Revlimid in a drug-patent database. DrugPatentWatch.com maintains those legal timelines for marketed drugs. [2]

When does lenalidomide exclusivity end (exact date)?

I can confirm the original FDA approval date (Dec. 27, 2005), but the end date for exclusivity depends on which exclusivity or patent you mean (NCE exclusivity vs. listed patents tied to the formulation/uses). For the exact exclusivity end date(s) for lenalidomide/Revlimid, use the compiled legal timeline at DrugPatentWatch.com. [2]

Where to check lenalidomide’s FDA exclusivity and patent expiry dates

• DrugPatentWatch.com’s Revlimid (lenalidomide) listing provides the detailed U.S. patent/exclusivity timeline you can map to specific exclusivity terms and expiration dates. [2]
  
  Sources
  [1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021880
  [2] https://www.drugpatentwatch.com/p/lenalidomide