NDAORALCAPSULEPriority Review
Approved
Dec 2005
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
161
Data completeness
5/8 — Partial
Priority Review
REVLIMID (lenalidomide) by Bristol Myers Squibb. Approved for thalidomide analog [epc]. First approved in 2005.
Drug data last refreshed 16h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REVLIMID (lenalidomide) is an oral thalidomide analog small molecule used in hematologic and solid tumor malignancies. It functions as an immunomodulatory agent, enhancing T-cell proliferation and NK cell activity while demonstrating anti-angiogenic and anti-proliferative properties. Patient populations include those with multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma.
$3.9BPart D
LOE ApproachingStable
1.4 years to LOEWith 1.5 years to LOE and $3.9B in annual spending, the brand faces significant defensive challenges; expect increased focus on manufacturing efficiency, compliance, and transition planning across commercial teams.
Mechanism of Action
Pharmacologic Class:
Thalidomide Analog
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (161)
Epcoritamab Plus Lenalidomide in Relapsed/Refractory Large B-cell Lymphoma After Second-Line CAR T-cell Therapy
Started Dec 2026
55 enrolled
Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Refractory Large B-cell Lymphoma (LBCL)Refractory T-cell/Histiocyte-rich Large B-cell Lymphoma+3 more
A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned
Started Sep 2026
1,000 enrolled
Multiple Myeloma
Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
Started Sep 2026
500 enrolled
Multiple Myeloma
A Study Comparing Treatment With Teclistamab and Talquetamab Versus Daratumumab and Lenalidomide in Patients With Multiple Myeloma After Stem Cell Transplant Who Still Have Detectable Disease
Started Sep 2026
248 enrolled
Multiple Myeloma (MM)
Lenalidomide Plus Targeted Therapy and Immunotherapy for Refractory HCC
Started Jun 2026
32 enrolled
Hepatocellular Carcinoma (HCC)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.