Revlimid
An oral immunomodulator for multiple myeloma and related blood cancers.
Where Lenalidomide is approved
All regulators →Of the three regulators tracked here, the first to approve Lenalidomide was the US, on 27 Dec 2005. It is approved in 3 of the 3 regulators tracked here.
- 5 EU orphan designations, most recently for treatment of marginal zone lymphoma (24 Apr 2015, withdrawn)
- 1 EU safety letter (DHPC), latest: quality defect for Lenalidomide Mylan, 29 Oct 2025
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Lenalidomide patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Lenalidomide, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 2 listed patents; the last listed expires 8 Mar 2028 (US 8741929).
- Latest patent on the drug substance itself: 27 Apr 2027 (US 7465800).
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Lenalidomide
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Lenalidomide works
All drug targets →- CRL4(CRBN) E3 ubiquitin ligase inhibitor InhibitorTarget: CRL4(CRBN) E3 ubiquitin ligase✓ In ChEMBL and the Guide to Pharmacology
- CRL4(CRBN) E3 ubiquitin ligase modulator ModulatorTarget: CRL4(CRBN) E3 ubiquitin ligase✓ In ChEMBL and the Guide to Pharmacology
- B-cell chronic lymphocytic leukemiaPhase 3
- Sezary syndromePhase 3
- Acute myeloid leukemiaPhase 3
- Anemia (phenotype)Phase 3
- Complex regional pain syndrome type 1Phase 3
- Cutaneous lupus erythematosusPhase 3
- Diffuse large B-cell lymphomaPhase 3
- Hemophagocytic syndromePhase 3
- Immunodeficiency 32BPhase 3
- Marginal zone lymphomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL848, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7331, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Lenalidomide
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 8 technology appraisals of Lenalidomide. 8 are current, and 6 of these recommend it for at least some patients.
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Lenalidomide
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 48 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Revlimid, Lenalidomide Accord (generic), Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) (generic), Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka) (generic), Lenalidomide Mylan (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Lenalidomide
- ATC code
- L04AX04
- ChEMBL
- CHEMBL848
- DrugBank
- DB00480
- PubChem CID
- 216326
- CAS number
- 191732-72-6
- FDA UNII
- F0P408N6V4
- Wikidata
- Q425681
- Wikipedia
- Lenalidomide
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Revlimid is used for
REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: • Multiple myeloma (MM), in combination with dexamethasone ( 1.1 ). • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1 ). • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2 ). • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3 ). • Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4 ). • Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5 ). Limitations of Use: • REVLIMID is not indicated and is not recommended for the treatment of patients wit…
How it works
12.1 Mechanism of Action Lenalidomide is an analogue of thalidomide with 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) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects. Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells including MM, mantle cell lymphoma, and del (5q) myelodysplastic syndromes, follicular lymphoma and marginal zone l…
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 8 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.