Data updated: May 26, 2026
IMBRUVICA (ibrutinib)
Protein Kinase Inhibitors Genetically Validated
Trial Activity: Stable 84 active trials
Oncology
Approved 2013-11-13
IMBRUVICA is indicated for the treatment of Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenstrom Macroglobulinemia; Marginal Zone Lymphoma; Graft Versus Host Disease.
How IMBRUVICA Works
Ibrutinib is a small-molecule inhibitor that targets Bruton’s tyrosine kinase (BTK) by forming a covalent bond with a cysteine residue in the enzyme's active site. This inhibition disrupts BTK’s role in signaling through the B-cell antigen receptor and cytokine receptor pathways, which are necessary for B-cell trafficking, chemotaxis, and adhesion. By blocking these pathways, the drug inhibits the proliferation and survival of malignant B-cells. It also prevents cell migration and substrate adhesion in B-cell populations.
Development Insights
National Cancer Institute (NCI) conducting 24 trials (9%)
337 indications explored (Broad Platform)
→ chronic lymphocytic leukemia (48 trials)
→ mantle cell lymphoma (27 trials)
→ small lymphocytic lymphoma (24 trials)
16
Indications
--
Phase 3 Trials
14
Priority Reviews
12
Years on Market
Details
- Status
- Prescription
- First Approved
- 2013-11-13
- Patent Cliff
- 2039
- Revenue
- $556M (Q1-2026)
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, TABLET, CAPSULE
IMBRUVICA Approval History
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
181 FDA actions from 2013 to 2025 · 13 indication expansions
Jun 2016 SUPPL Priority
Mfg
Apr 2016 SUPPL Priority
Mfg
Mar 2016 SUPPL Priority
Mfg
Feb 2016 SUPPL Priority
Mfg
Nov 2015 SUPPL Priority
Mfg
Aug 2015 SUPPL Priority
Mfg
Aug 2015 SUPPL Priority
Mfg
What IMBRUVICA Treats
5 indicationsIMBRUVICA is approved for 5 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Mantle Cell Lymphoma
- Chronic Lymphocytic Leukemia
- Waldenstrom Macroglobulinemia
- Marginal Zone Lymphoma
- Graft Versus Host Disease
Source: FDA Label
IMBRUVICA Target & Pathway
ProTarget
A kinase essential for B-cell development and signaling. BTK inhibitors block B-cell receptor signaling, making them highly effective in B-cell malignancies like chronic lymphocytic leukemia and mantle cell lymphoma.
IMBRUVICA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
2
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
2
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 8 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in IMBRUVICA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications IMBRUVICA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to IMBRUVICA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
JAYPIRCA
PIRTOBRUTINIB
LOXO ONCOL
Shared indications:
Mantle Cell LymphomaChronic Lymphocytic Leukemia
REVLIMID
LENALIDOMIDE
Bristol-Myers Squibb
Shared indications:
Mantle Cell LymphomaMarginal Zone Lymphoma
📋
Clinical Trial Registry
257 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06649812 | NCI-2024-08642 NCI-2024-08642, EA4231 | Ph 2 | recruiting | Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma |
| NCT04840602 | NCI-2021-02851 NCI-2021-02851, S2005 | Ph 2 | recruiting | Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma |
| NCT03701282 | NCI-2018-02127 NCI-2018-02127, EA9161 | Ph 3 | active not recruiting | Assessing the Ability of Combination Treatment With Venetoclax to Permit Time Limited Therapy in Chronic Lymphocytic Leukemia |
| NCT02160015 | NCI-2014-01157 NCI-2014-01157, 2015-00531 | Ph 1 | active not recruiting | Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery |
| NCT01841723 | NCI-2013-00826 NCI-2013-00826, 2012C0139 | Ph 2 | active not recruiting | Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia |
| NCT01955499 | NCI-2013-01810 NCI-2013-01810, OSU 13022 | Ph 1 | active not recruiting | Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma |
| NCT04263480 CZAR-1 | CZAR-1 | Ph 2 | active not recruiting | Efficacy and Safety of Carfilzomib in Combination With Ibrutinib vs Ibrutinib in Waldenström's Macroglobulinemia |
| NCT06136559 | 1026-011 2022-501697-19-00, U1111-1281-7895 | Ph 3 | recruiting | A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011) |
| NCT04273139 results posted | 19-651 | Ph 2 | active not recruiting | Ibrutinib + Venetoclax in Untreated WM |
| NCT03462719 GLOW results posted | CR108428 2017-004699-77, 54179060CLL3011 | Ph 3 | active not recruiting | A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) |
| NCT01804686 CAN3001 | CR100955 PCI-32765CAN3001, 2012-004225-24 | Ph 3 | recruiting | A Long-term Extension Study of PCI-32765 (Ibrutinib) |
| NCT05963074 TAILOR | 54179060CLL2032 54179060CLL2032, 2023-504044-34-00 | Ph 2 | recruiting | A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia |
| NCT05283720 | M22-132 2023-505347-38, 2023-505347-38-00 | Ph 2 | recruiting | A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma |
| NCT07082868 | 25-032 | Ph 1 | recruiting | A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL) |
| NCT03506373 results posted | MC178B 18-000580 | Ph 2 | terminated | Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia |
| NCT02443077 results posted | NCI-2015-00668 NCI-2015-00668, BMT CTN 1201 | Ph 3 | active not recruiting | Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma |
| NCT01886872 results posted | NCI-2013-01220 NCI-2013-01220, ALLIANCE A041202 | Ph 3 | active not recruiting | Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia |
| NCT03737981 results posted | NCI-2018-02485 NCI-2018-02485, A041702 | Ph 3 | active not recruiting | Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia |
| NCT02048813 results posted | NCI-2014-00118 NCI-2014-00118, E1912 | Ph 3 | active not recruiting | Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| NCT02581930 results posted | NCI-2015-01744 NCI-2015-01744, NCI9922 | Ph 2 | active not recruiting | Ibrutinib in Treating Patients With Refractory Metastatic Cutaneous Melanoma |
| NCT04608318 CLL17 | CLL17 2022-500439-35-00, 2019-003854-99 | Ph 3 | active not recruiting | Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) |
| NCT03964090 | 190103 19-C-0103 | Ph 2 | active not recruiting | Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS) |
| NCT01849263 results posted | NCI-2013-00887 NCI-2013-00887, MC1282 | Ph 2 | active not recruiting | Ibrutinib in Treating Patients With Relapsed or Refractory Follicular Lymphoma |
| NCT04739813 | 210014 21-C-0014 | Ph 1 | recruiting | Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma |
| NCT03479268 | 19565 NCI-2018-00315, STUDY00017005 | Ph 1 | active not recruiting | Pevonedistat and Ibrutinib in Treating Participants With Relapsed or Refractory CLL or Non-Hodgkin Lymphoma |
| NCT02436707 | LY17 | Ph 2 | active not recruiting | Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma |
| NCT03223610 | 170127 17-C-0127 | Ph 1, Ph 2 | recruiting | Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma |
| NCT05254743 BRUIN-CLL-314 | 18281 J2N-OX-JZNU, LOXO-BTK-20030 | Ph 3 | recruiting | A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) |
| NCT03960840 | CYTB323A12101 | Ph 1, Ph 2 | active not recruiting | Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL |
| NCT03328078 | CA-4948-101 2024-513312-95-00, 2022-000891-20 | Ph 1, Ph 2 | recruiting | CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL) |
| NCT05998642 | I244 | Ph 2 | recruiting | Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma |
| NCT02514083 results posted | 150172 15-H-0172 | Ph 2 | active not recruiting | A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL |
| NCT01829568 | NCI-2013-00792 NCI-2013-00792, CALGB-A051103 | Ph 1 | active not recruiting | Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma |
| NCT01589302 results posted | OSU-11133 NCI-2012-00560 | Ph 2 | active not recruiting | PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia |
| NCT04450173 | UCDCC#275 NCI-2020-01372, UCDCC#275 | Ph 2 | active not recruiting | Obinutuzumab, Ibrutinib, and Venetoclax for the Treatment of Previously Untreated Stage II-IV Follicular Lymphoma |
| NCT02159755 | NCI-2014-01202 NCI-2014-01202, 1403014853 | Ph 1 | active not recruiting | Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma |
| NCT03220022 results posted | NCI-2017-01240 NCI-2017-01240, AMC-101 | Ph 1 | active not recruiting | Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas |
| NCT03478514 | AFT-32 | Ph 2 | active not recruiting | Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma |
| NCT03697512 MALIBU | IELSG47 2018-002364-44 | Ph 2 | active not recruiting | MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas |
| NCT02997761 | 945122 UCDCC#266, UCDCC#266 | Ph 2 | completed | Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia |
| NCT02518555 | OSU-15012 NCI-2015-00932 | Ph 2 | completed | Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| NCT02537613 | 15-283 | Ph 1 | active not recruiting | A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia |
| NCT02477696 results posted | ACE-CL-006 2023-509347-27-00, 2014-005530-64 | Ph 3 | active not recruiting | Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL) |
| NCT02682641 | GELTAMO-IMCL-2015 2015-004158-17 | Ph 2 | active not recruiting | Ibrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of MCL |
| NCT02446236 results posted | Pro00005444 | Ph 1 | active not recruiting | Dose Finding Study of Ibrutinib Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma |
| NCT03282396 | 2016-0914 NCI-2018-01045, 2016-0914 | Ph 2 | active not recruiting | Ibrutinib in Treating Participants With Untreated High Risk Smoldering Mantle Cell Lymphoma |
| NCT03359460 | 1043625 UCDCC#265, UCDCC#265 | Ph 1 | completed | Ibrutinib and Lenalidomide in Treating Patients With Myelodysplastic Syndrome |
| NCT02629809 | 2015-0281 NCI-2016-00016, 2015-0281 | Ph 2 | active not recruiting | Ibrutinib, Fludarabine Phosphate, Cyclophosphamide, and Obinutuzumab in Treating Patients With Chronic Lymphocytic Leukemia |
| NCT03514017 results posted | MCC-19199 | Ph 2 | terminated | Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia |
| NCT04421560 | 20-144 | Ph 1, Ph 2 | recruiting | Pembrolizumab, Ibrutinib and Rituximab in PCNSL |
Showing 50 of 257 trials
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IMBRUVICA FDA Label Details
Indications & Usage
FDA Label (PDF)IMBRUVICA is indicated for the treatment of Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenstrom Macroglobulinemia; Marginal Zone Lymphoma; Graft Versus Host Disease.
View full patent landscape →
83 OB patents · 7 families ·
735 international docs across 51 countries
IMBRUVICA Patents & Exclusivity
Latest Patent: Jun 2039
Exclusivity: Feb 2030
Patents (84 active)
US12201690
Expires Jun 14, 2039
US9655857*PED
Expires Sep 3, 2036
US10010507*PED
Expires Sep 3, 2036
US10213386*PED
Expires Sep 3, 2036
US10828259*PED
Expires Sep 3, 2036
US12364698
Expires Apr 6, 2036
US10010507
Expires Mar 3, 2036
US10213386
Expires Mar 3, 2036
US12551448
Expires Mar 3, 2036
US9655857
Expires Mar 3, 2036
US10828259
Expires Mar 3, 2036
US9795604*PED
Expires Apr 24, 2035
US10463668*PED
Expires Apr 24, 2035
US10695350*PED
Expires Apr 24, 2035
US9795604
Expires Oct 24, 2034
US10463668
Expires Oct 24, 2034
US10695350
Expires Oct 24, 2034
US9296753*PED
Expires Apr 30, 2034
US9540382*PED
Expires Feb 18, 2034
US9725455*PED
Expires Dec 3, 2033
US10106548*PED
Expires Dec 3, 2033
US10125140*PED
Expires Dec 3, 2033
US10961251*PED
Expires Dec 3, 2033
US9713617*PED
Expires Dec 3, 2033
US10294232*PED
Expires Dec 3, 2033
US10294231*PED
Expires Dec 3, 2033
US10752634*PED
Expires Dec 3, 2033
US9296753
Expires Oct 30, 2033
US9540382
Expires Aug 18, 2033
US10106548
Expires Jun 3, 2033
US9725455
Expires Jun 3, 2033
US10125140
Expires Jun 3, 2033
US10961251
Expires Jun 3, 2033
US10752634
Expires Jun 3, 2033
US9713617
Expires Jun 3, 2033
US10294231
Expires Jun 3, 2033
US10294232
Expires Jun 3, 2033
US10478439*PED
Expires Dec 3, 2031
US9125889*PED
Expires Dec 3, 2031
US10004746*PED
Expires Dec 3, 2031
US9801883*PED
Expires Dec 3, 2031
US9801881*PED
Expires Dec 3, 2031
US8999999*PED
Expires Dec 3, 2031
US10016435*PED
Expires Dec 3, 2031
US10751342*PED
Expires Dec 3, 2031
US8754090*PED
Expires Dec 3, 2031
US9814721*PED
Expires Dec 3, 2031
US10653696*PED
Expires Dec 3, 2031
US10478439
Expires Jun 3, 2031
US8999999
Expires Jun 3, 2031
US9125889
Expires Jun 3, 2031
US9801881
Expires Jun 3, 2031
US9801883
Expires Jun 3, 2031
US10004746
Expires Jun 3, 2031
US10016435
Expires Jun 3, 2031
US10751342
Expires Jun 3, 2031
US11672803
Expires Jun 3, 2031
US8754090
Expires Jun 3, 2031
US9814721
Expires Jun 3, 2031
US10653696
Expires Jun 3, 2031
US8008309*PED
Expires May 13, 2028
US8008309
Expires Nov 13, 2027
US8563563*PED
Expires Oct 26, 2027
US8697711*PED
Expires Jun 28, 2027
US8735403*PED
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US8497277*PED
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US7514444*PED
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US8957079*PED
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US9181257*PED
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US8754091*PED
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US8476284*PED
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US8703780*PED
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US8952015*PED
Expires Jun 28, 2027
US8563563
Expires Apr 26, 2027
US8703780
Expires Dec 28, 2026
US8952015
Expires Dec 28, 2026
US8476284
Expires Dec 28, 2026
US8497277
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US8957079
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US8735403
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US9181257
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US8754091
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US8697711
Expires Dec 28, 2026
US7514444
Expires Dec 28, 2026
Exclusivity
NP
Until Aug 2025
ODE-405
Until Aug 2029
PED
Until Feb 2030
PED
Until Feb 2026
NP
Until Aug 2025
ODE-405
Until Aug 2029
PED
Until Feb 2030
PED
Until Feb 2026
NP
Until Aug 2025
ODE-405
Until Aug 2029
PED
Until Feb 2030
PED
Until Feb 2026
NP
Until Aug 2025
ODE-405
Until Aug 2029
PED
Until Feb 2030
PED
Until Feb 2026
NP
Until Aug 2025
ODE-405
Until Aug 2029
PED
Until Feb 2030
PED
Until Feb 2026
NP
Until Aug 2025
ODE-405
Until Aug 2029
PED
Until Feb 2030
PED
Until Feb 2026
NP
Until Aug 2025
ODE-405
Until Aug 2029
PED
Until Feb 2030
PED
Until Feb 2026
NPP
Until Aug 2025
ODE-405
Until Aug 2029
NPP
Until Aug 2025
ODE-405
Until Aug 2029
PED
Until Feb 2030
PED
Until Feb 2030
PED
Until Feb 2026
PED
Until Feb 2026
NPP
Until Aug 2025
ODE-405
Until Aug 2029
NPP
Until Aug 2025
ODE-405
Until Aug 2029
PED
Until Feb 2030
PED
Until Feb 2030
PED
Until Feb 2026
PED
Until Feb 2026
NPP
Until Aug 2025
ODE-405
Until Aug 2029
NPP
Until Aug 2025
ODE-405
Until Aug 2029
NPP
Until Aug 2025
ODE-405
Until Aug 2029
NPP
Until Aug 2025
ODE-405
Until Aug 2029
PED
Until Feb 2030
PED
Until Feb 2030
PED
Until Feb 2030
PED
Until Feb 2030
PED
Until Feb 2026
PED
Until Feb 2026
PED
Until Feb 2026
PED
Until Feb 2026
NPP
Until Aug 2025
ODE-405
Until Aug 2029
NPP
Until Aug 2025
ODE-405
Until Aug 2029
NPP
Until Aug 2025
ODE-405
Until Aug 2029
NPP
Until Aug 2025
ODE-405
Until Aug 2029
PED
Until Feb 2030
PED
Until Feb 2030
PED
Until Feb 2030
PED
Until Feb 2030
PED
Until Feb 2026
PED
Until Feb 2026
PED
Until Feb 2026
PED
Until Feb 2026
NPP
Until Aug 2025
ODE-405
Until Aug 2029
NPP
Until Aug 2025
ODE-405
Until Aug 2029
NPP
Until Aug 2025
ODE-405
Until Aug 2029
NPP
Until Aug 2025
ODE-405
Until Aug 2029
PED
Until Feb 2030
PED
Until Feb 2030
PED
Until Feb 2030
PED
Until Feb 2030
PED
Until Feb 2026
PED
Until Feb 2026
PED
Until Feb 2026
PED
Until Feb 2026
NPP
Until Aug 2025
ODE-405
Until Aug 2029
NPP
Until Aug 2025
ODE-405
Until Aug 2029
NPP
Until Aug 2025
ODE-405
Until Aug 2029
NPP
Until Aug 2025
ODE-405
Until Aug 2029
PED
Until Feb 2030
PED
Until Feb 2030
PED
Until Feb 2030
PED
Until Feb 2030
PED
Until Feb 2026
PED
Until Feb 2026
PED
Until Feb 2026
PED
Until Feb 2026
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for IMBRUVICA
Revenue Insights
- • Q1-2026: $556M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 2690 active patents
Trial Analysis
- • 260 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment