REVLIMID

LOE Approaching

lenalidomide

NDAORALCAPSULEPriority Review
Approved
Dec 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
298

Mechanism of Action

immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of lenalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. In vitro, in the presence of drug, substrate proteins (including Aiolos, Ikaros, and CK1α)…

Pharmacologic Class:

Thalidomide Analog

Clinical Trials (5)

NCT07285239Phase 3Not Yet Recruiting

Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma

Started May 2026
500 enrolled
Multiple Myeloma
NCT07465029N/AActive Not Recruiting

A Study of Incidence, Treatment Patterns, and Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in Spain

Started Feb 2026
1,300 enrolled
Lower-risk Myelodysplastic Syndromes (TD LR-MDS)
NCT07095452Phase 2/3Recruiting

A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Started Jan 2026
660 enrolled
Multiple Myeloma
NCT06910124Phase 2Recruiting

Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse

Started Dec 2025
32 enrolled
Multiple Myeloma
NCT06517017Phase 2Recruiting

Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma

Started Oct 2025
40 enrolled
Multiple MyelomaPlasma Cell Leukemia

Loss of Exclusivity

LOE Date
Mar 8, 2028
24 months away
Patent Expiry
Mar 8, 2028
Exclusivity Expiry
May 28, 2026

Patent Records (2)

Patent #ExpiryTypeUse Code
7465800
Apr 27, 2027
SubstanceProduct
8741929
Mar 8, 2028
U-1983