Product profile · United States
IMBRUVICA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
NDA 210563/S-017 removes the 560 mg tablet. FDA approval event 2023-05-18 and letter electronic signature 2023-05-18; web posting date 2023-05-19 is not the event date. Canonical patent/exclusivity assessment is preserved as historical supporting data; it does not override this product status.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7514444 | 2026-12-28 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 7514444 | 2026-12-28 | DS/DP — | Y | Y | TRUE_DS Independent Formula D genus includes ibrutinib with phenoxy, piperidine, carbonyl and terminal alkene substituents. Corrected species structures visually checked; no crystal/formulation/indication restriction. | — | — | — |
| 8476284 | 2026-12-28 | U U-2241 | N | N | LIMITED_USE | — | — | — |
| 8476284 | 2026-12-28 | U U-1947 | N | N | LIMITED_USE | — | — | — |
| 8476284 | 2026-12-28 | U U-1456 | N | N | LIMITED_USE | — | — | — |
| 8476284 | 2026-12-28 | U U-1650 | N | N | LIMITED_USE | — | — | — |
| 8476284 | 2026-12-28 | U U-1946 | N | N | LIMITED_USE | — | — | — |
| 8476284 | 2026-12-28 | U U-1946 | N | N | LIMITED_USE Ibrutinib/genus treatment of lymphoma; excludes the full approved cGVHD and other non-lymphoma scopes. | — | — | — |
| 8476284 | 2026-12-28 | U U-2241 | N | N | LIMITED_USE Ibrutinib/genus treatment of lymphoma; excludes the full approved cGVHD and other non-lymphoma scopes. | — | — | — |
| 8476284 | 2026-12-28 | U U-1456 | N | N | LIMITED_USE Ibrutinib/genus treatment of lymphoma; excludes the full approved cGVHD and other non-lymphoma scopes. | — | — | — |
| 8476284 | 2026-12-28 | U U-1947 | N | N | LIMITED_USE Ibrutinib/genus treatment of lymphoma; excludes the full approved cGVHD and other non-lymphoma scopes. | — | — | — |
| 8476284 | 2026-12-28 | U U-1650 | N | N | LIMITED_USE Ibrutinib/genus treatment of lymphoma; excludes the full approved cGVHD and other non-lymphoma scopes. | — | — | — |
| 8497277 | 2026-12-28 | U U-1947 | N | N | LIMITED_USE | — | — | — |
| 8497277 | 2026-12-28 | U U-1946 | N | N | LIMITED_USE | — | — | — |
| 8497277 | 2026-12-28 | U U-2242 | N | N | LIMITED_USE | — | — | — |
| 8497277 | 2026-12-28 | U U-2241 | N | N | LIMITED_USE | — | — | — |
| 8497277 | 2026-12-28 | U U-1456 | N | N | LIMITED_USE | — | — | — |
| 8497277 | 2026-12-28 | U U-1491 | N | N | LIMITED_USE | — | — | — |
| 8497277 | 2026-12-28 | U U-1650 | N | N | LIMITED_USE | — | — | — |
| 8497277 | 2026-12-28 | U U-1456 | N | N | LIMITED_USE Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | — | — | — |
| 8497277 | 2026-12-28 | U U-1650 | N | N | LIMITED_USE Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | — | — | — |
| 8497277 | 2026-12-28 | U U-1491 | N | N | LIMITED_USE Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | — | — | — |
| 8497277 | 2026-12-28 | U U-1947 | N | N | LIMITED_USE Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | — | — | — |
| 8497277 | 2026-12-28 | U U-2242 | N | N | LIMITED_USE Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | — | — | — |
| 8497277 | 2026-12-28 | U U-2241 | N | N | LIMITED_USE Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | — | — | — |
| 8497277 | 2026-12-28 | U U-1946 | N | N | LIMITED_USE Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | — | — | — |
| 8697711 | 2026-12-28 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 8697711 | 2026-12-28 | DS/DP — | Y | Y | TRUE_DS Independent claim 1 visually claims the ibrutinib molecular structure without stereochemical, crystal, formulation or indication restriction; includes the approved R enantiomer. Claim 3 separately claims the opposite enantiomer and was not used as the anchor. | — | — | — |
| 8703780 | 2026-12-28 | U U-2242 | N | N | LIMITED_USE | — | — | — |
| 8703780 | 2026-12-28 | U U-1491 | N | N | LIMITED_USE | — | — | — |
| 8703780 | 2026-12-28 | U U-1491 | N | N | LIMITED_USE Ibrutinib/genus leukemia treatment; not all current malignancy and cGVHD indications. | — | — | — |
| 8703780 | 2026-12-28 | U U-2242 | N | N | LIMITED_USE Ibrutinib/genus leukemia treatment; not all current malignancy and cGVHD indications. | — | — | — |
| 8735403 | 2026-12-28 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 8735403 | 2026-12-28 | DS/DP — | Y | Y | TRUE_DS Independent claims 1 and 11 define irreversible BTK inhibitor compound genera including ibrutinib; no crystal, formulation or indication limits. Chemical genera and corrected structures visually checked. | — | — | — |
| 8754091 | 2026-12-28 | DP — | N | Y | DS_EQUIVALENT | — | — | — |
| 8754091 | 2026-12-28 | DP — | N | Y | DS_EQUIVALENT Independent claim 21 broadly requires ibrutinib and a pharmaceutically acceptable excipient, without specified form, dose or release mechanism; spans all product indications. It is a composition claim rather than new-molecule TrueDS. | — | — | — |
| 8952015 | 2026-12-28 | U U-1947 | N | N | LIMITED_USE | — | — | — |
| 8952015 | 2026-12-28 | U U-1946 | N | N | LIMITED_USE | — | — | — |
| 8952015 | 2026-12-28 | U U-1650 | N | N | LIMITED_USE | — | — | — |
| 8952015 | 2026-12-28 | U U-2241 | N | N | LIMITED_USE | — | — | — |
| 8952015 | 2026-12-28 | U U-1456 | N | N | LIMITED_USE | — | — | — |
| 8952015 | 2026-12-28 | U U-2242 | N | N | LIMITED_USE | — | — | — |
| 8952015 | 2026-12-28 | U U-1491 | N | N | LIMITED_USE | — | — | — |
| 8952015 | 2026-12-28 | U U-1491 | N | N | LIMITED_USE Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | — | — | — |
| 8952015 | 2026-12-28 | U U-1947 | N | N | LIMITED_USE Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | — | — | — |
| 8952015 | 2026-12-28 | U U-2241 | N | N | LIMITED_USE Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | — | — | — |
| 8952015 | 2026-12-28 | U U-1456 | N | N | LIMITED_USE Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | — | — | — |
| 8952015 | 2026-12-28 | U U-1650 | N | N | LIMITED_USE Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | — | — | — |
| 8952015 | 2026-12-28 | U U-2242 | N | N | LIMITED_USE Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | — | — | — |
| 8952015 | 2026-12-28 | U U-1946 | N | N | LIMITED_USE Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | — | — | — |
| 8957079 | 2026-12-28 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 8957079 | 2026-12-28 | DS/DP — | Y | Y | TRUE_DS Independent compound genus includes ibrutinib pyrazolopyrimidine, phenoxyphenyl, piperidine and Michael-acceptor substituents. Structure visually checked; no formulation or indication restriction. | — | — | — |
| 9181257 | 2026-12-28 | DS — | Y | Y | TRUE_DS | — | — | — |
| 9181257 | 2026-12-28 | DS — | Y | Y | TRUE_DS Independent Formula A genus includes ibrutinib scaffold and nitrogen heterocycle/Michael acceptor; visually checked and unrestricted by crystal, formulation or disease. | — | — | — |
| 8563563 | 2027-04-26 | U U-1650 | N | N | LIMITED_COMBINATION_USE | — | — | — |
| 8563563 | 2027-04-26 | U U-1491 | N | N | LIMITED_COMBINATION_USE | — | — | — |
| 8563563 | 2027-04-26 | U U-2242 | N | N | LIMITED_COMBINATION_USE | — | — | — |
| 8563563 | 2027-04-26 | U U-1946 | N | N | LIMITED_COMBINATION_USE | — | — | — |
| 8563563 | 2027-04-26 | U U-2241 | N | N | LIMITED_COMBINATION_USE | — | — | — |
| 8563563 | 2027-04-26 | U U-1650 | N | N | LIMITED_COMBINATION_USE Ibrutinib/genus plus anticancer agent for B-cell proliferative disease/myeloma; does not cover monotherapy and cGVHD. | — | — | — |
| 8563563 | 2027-04-26 | U U-1491 | N | N | LIMITED_COMBINATION_USE Ibrutinib/genus plus anticancer agent for B-cell proliferative disease/myeloma; does not cover monotherapy and cGVHD. | — | — | — |
| 8563563 | 2027-04-26 | U U-1946 | N | N | LIMITED_COMBINATION_USE Ibrutinib/genus plus anticancer agent for B-cell proliferative disease/myeloma; does not cover monotherapy and cGVHD. | — | — | — |
| 8563563 | 2027-04-26 | U U-2241 | N | N | LIMITED_COMBINATION_USE Ibrutinib/genus plus anticancer agent for B-cell proliferative disease/myeloma; does not cover monotherapy and cGVHD. | — | — | — |
| 8563563 | 2027-04-26 | U U-2242 | N | N | LIMITED_COMBINATION_USE Ibrutinib/genus plus anticancer agent for B-cell proliferative disease/myeloma; does not cover monotherapy and cGVHD. | — | — | — |
| 7514444 | 2027-06-28 | — — | Y | Y | TRUE_DS | — | 2027-06-28 | — |
| 7514444 | 2027-06-28 | PED — | Y | Y | TRUE_DS Independent Formula D genus includes ibrutinib with phenoxy, piperidine, carbonyl and terminal alkene substituents. Corrected species structures visually checked; no crystal/formulation/indication restriction. | — | — | — |
| 8476284 | 2027-06-28 | — — | N | N | LIMITED_USE | — | 2027-06-28 | — |
| 8476284 | 2027-06-28 | PED — | N | N | LIMITED_USE Ibrutinib/genus treatment of lymphoma; excludes the full approved cGVHD and other non-lymphoma scopes. | — | — | — |
| 8497277 | 2027-06-28 | — — | N | N | LIMITED_USE | — | 2027-06-28 | — |
| 8497277 | 2027-06-28 | PED — | N | N | LIMITED_USE Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | — | — | — |
| 8697711 | 2027-06-28 | — — | Y | Y | TRUE_DS | — | 2027-06-28 | — |
| 8697711 | 2027-06-28 | PED — | Y | Y | TRUE_DS Independent claim 1 visually claims the ibrutinib molecular structure without stereochemical, crystal, formulation or indication restriction; includes the approved R enantiomer. Claim 3 separately claims the opposite enantiomer and was not used as the anchor. | — | — | — |
| 8703780 | 2027-06-28 | — — | N | N | LIMITED_USE | — | 2027-06-28 | — |
| 8703780 | 2027-06-28 | PED — | N | N | LIMITED_USE Ibrutinib/genus leukemia treatment; not all current malignancy and cGVHD indications. | — | — | — |
| 8735403 | 2027-06-28 | — — | Y | Y | TRUE_DS | — | 2027-06-28 | — |
| 8735403 | 2027-06-28 | PED — | Y | Y | TRUE_DS Independent claims 1 and 11 define irreversible BTK inhibitor compound genera including ibrutinib; no crystal, formulation or indication limits. Chemical genera and corrected structures visually checked. | — | — | — |
| 8754091 | 2027-06-28 | — — | N | Y | DS_EQUIVALENT | — | 2027-06-28 | — |
| 8754091 | 2027-06-28 | PED — | N | Y | DS_EQUIVALENT Independent claim 21 broadly requires ibrutinib and a pharmaceutically acceptable excipient, without specified form, dose or release mechanism; spans all product indications. It is a composition claim rather than new-molecule TrueDS. | — | — | — |
| 8952015 | 2027-06-28 | — — | N | N | LIMITED_USE | — | 2027-06-28 | — |
| 8952015 | 2027-06-28 | PED — | N | N | LIMITED_USE Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | — | — | — |
| 8957079 | 2027-06-28 | — — | Y | Y | TRUE_DS | — | 2027-06-28 | — |
| 8957079 | 2027-06-28 | PED — | Y | Y | TRUE_DS Independent compound genus includes ibrutinib pyrazolopyrimidine, phenoxyphenyl, piperidine and Michael-acceptor substituents. Structure visually checked; no formulation or indication restriction. | — | — | — |
| 9181257 | 2027-06-28 | — — | Y | Y | TRUE_DS | — | 2027-06-28 | — |
| 9181257 | 2027-06-28 | PED — | Y | Y | TRUE_DS Independent Formula A genus includes ibrutinib scaffold and nitrogen heterocycle/Michael acceptor; visually checked and unrestricted by crystal, formulation or disease. | — | — | — |
| 8563563 | 2027-10-26 | — — | N | N | LIMITED_COMBINATION_USE | — | 2027-10-26 | — |
| 8563563 | 2027-10-26 | PED — | N | N | LIMITED_COMBINATION_USE Ibrutinib/genus plus anticancer agent for B-cell proliferative disease/myeloma; does not cover monotherapy and cGVHD. | — | — | — |
| 8008309 | 2027-11-13 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 8008309 | 2027-11-13 | DS/DP — | Y | Y | TRUE_DS Independent compound genus includes ibrutinib; exact ibrutinib name appears in dependent claim 10 as corrected. Genus structure and correction visually checked; no crystal/formulation/indication restriction. | — | — | — |
| 8008309 | 2028-05-13 | — — | Y | Y | TRUE_DS | — | 2028-05-13 | — |
| 8008309 | 2028-05-13 | PED — | Y | Y | TRUE_DS Independent compound genus includes ibrutinib; exact ibrutinib name appears in dependent claim 10 as corrected. Genus structure and correction visually checked; no crystal/formulation/indication restriction. | — | — | — |
| 10004746 | 2031-06-03 | U U-2242 | N | N | LIMITED_USE | — | — | — |
| 10004746 | 2031-06-03 | U U-2241 | N | N | LIMITED_USE | — | — | — |
| 10004746 | 2031-06-03 | U U-1684 | N | N | LIMITED_USE | — | — | — |
| 10004746 | 2031-06-03 | U U-1946 | N | N | LIMITED_USE | — | — | — |
| 10004746 | 2031-06-03 | U U-1946 | N | N | LIMITED_USE CLL/SLL after at least one prior therapy, 420 mg once daily; does not cover all current ibrutinib indications. | — | — | — |
| 10004746 | 2031-06-03 | U U-1684 | N | N | LIMITED_USE CLL/SLL after at least one prior therapy, 420 mg once daily; does not cover all current ibrutinib indications. | — | — | — |
| 10004746 | 2031-06-03 | U U-2242 | N | N | LIMITED_USE CLL/SLL after at least one prior therapy, 420 mg once daily; does not cover all current ibrutinib indications. | — | — | — |
| 10004746 | 2031-06-03 | U U-2241 | N | N | LIMITED_USE CLL/SLL after at least one prior therapy, 420 mg once daily; does not cover all current ibrutinib indications. | — | — | — |
| 10016435 | 2031-06-03 | U U-1650 | N | N | LIMITED_USE | — | — | — |
| 10016435 | 2031-06-03 | U U-1650 | N | N | LIMITED_USE Treatment-naive Waldenstrom macroglobulinemia at 420 mg daily; excludes other approved indications. | — | — | — |
| 10478439 | 2031-06-03 | U U-1684 | N | N | LIMITED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-2241 | N | N | LIMITED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-2665 | N | N | LIMITED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-1650 | N | N | LIMITED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-1456 | N | N | LIMITED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-2242 | N | N | LIMITED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-1946 | N | N | LIMITED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-1947 | N | N | LIMITED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-1650 | N | N | LIMITED_USE Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | — | — | — |
| 10478439 | 2031-06-03 | U U-1947 | N | N | LIMITED_USE Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | — | — | — |
| 10478439 | 2031-06-03 | U U-2241 | N | N | LIMITED_USE Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | — | — | — |
| 10478439 | 2031-06-03 | U U-1684 | N | N | LIMITED_USE Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | — | — | — |
| 10478439 | 2031-06-03 | U U-2242 | N | N | LIMITED_USE Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | — | — | — |
| 10478439 | 2031-06-03 | U U-1946 | N | N | LIMITED_USE Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | — | — | — |
| 10478439 | 2031-06-03 | U U-2665 | N | N | LIMITED_USE Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | — | — | — |
| 10478439 | 2031-06-03 | U U-1456 | N | N | LIMITED_USE Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | — | — | — |
| 10653696 | 2031-06-03 | U U-1456 | N | N | LIMITED_USE | — | — | — |
| 10653696 | 2031-06-03 | U U-1456 | N | N | LIMITED_USE Ibrutinib mantle cell lymphoma treatment; this indication is absent from the current approved label. | — | — | — |
| 10751342 | 2031-06-03 | U U-2943 | N | N | LIMITED_USE | — | — | — |
| 10751342 | 2031-06-03 | U U-1491 | N | N | LIMITED_USE | — | — | — |
| 10751342 | 2031-06-03 | U U-2944 | N | N | LIMITED_USE | — | — | — |
| 10751342 | 2031-06-03 | U U-1946 | N | N | LIMITED_USE | — | — | — |
| 10751342 | 2031-06-03 | U U-1946 | N | N | LIMITED_USE Relapsed/refractory CLL/SLL 420 mg daily with defined response/progression criteria; excludes other indications. | — | — | — |
| 10751342 | 2031-06-03 | U U-1491 | N | N | LIMITED_USE Relapsed/refractory CLL/SLL 420 mg daily with defined response/progression criteria; excludes other indications. | — | — | — |
| 10751342 | 2031-06-03 | U U-2943 | N | N | LIMITED_USE Relapsed/refractory CLL/SLL 420 mg daily with defined response/progression criteria; excludes other indications. | — | — | — |
| 10751342 | 2031-06-03 | U U-2944 | N | N | LIMITED_USE Relapsed/refractory CLL/SLL 420 mg daily with defined response/progression criteria; excludes other indications. | — | — | — |
| 8754090 | 2031-06-03 | U U-1456 | N | N | LIMITED_USE | — | — | — |
| 8754090 | 2031-06-03 | U U-1456 | N | N | LIMITED_USE Ibrutinib after prior therapy for mantle cell lymphoma, an indication absent from the current approved label. | — | — | — |
| 8999999 | 2031-06-03 | U U-2241 | N | N | LIMITED_USE | — | — | — |
| 8999999 | 2031-06-03 | U U-2242 | N | N | LIMITED_USE | — | — | — |
| 8999999 | 2031-06-03 | U U-1491 | N | N | LIMITED_USE | — | — | — |
| 8999999 | 2031-06-03 | U U-1946 | N | N | LIMITED_USE | — | — | — |
| 8999999 | 2031-06-03 | U U-1491 | N | N | LIMITED_USE Ibrutinib for relapsed/refractory CLL/SLL at specified oral daily doses; excludes other approved indications. | — | — | — |
| 8999999 | 2031-06-03 | U U-1946 | N | N | LIMITED_USE Ibrutinib for relapsed/refractory CLL/SLL at specified oral daily doses; excludes other approved indications. | — | — | — |
| 8999999 | 2031-06-03 | U U-2242 | N | N | LIMITED_USE Ibrutinib for relapsed/refractory CLL/SLL at specified oral daily doses; excludes other approved indications. | — | — | — |
| 8999999 | 2031-06-03 | U U-2241 | N | N | LIMITED_USE Ibrutinib for relapsed/refractory CLL/SLL at specified oral daily doses; excludes other approved indications. | — | — | — |
| 9125889 | 2031-06-03 | U U-1650 | N | N | LIMITED_USE | — | — | — |
| 9125889 | 2031-06-03 | U U-1650 | N | N | LIMITED_USE Ibrutinib for previously treated Waldenstrom macroglobulinemia; excludes treatment-naive WM and other indications. | — | — | — |
| 9801881 | 2031-06-03 | U U-1491 | N | N | SUBPOPULATION_USE | — | — | — |
| 9801881 | 2031-06-03 | U U-2242 | N | N | SUBPOPULATION_USE | — | — | — |
| 9801881 | 2031-06-03 | U U-2242 | N | N | SUBPOPULATION_USE Claims 1 and 3 require previously treated or relapsed/refractory CLL with 420 mg daily; exclude other approved indications and treatment-naive patients. | — | — | — |
| 9801881 | 2031-06-03 | U U-1491 | N | N | SUBPOPULATION_USE Claims 1 and 3 require previously treated or relapsed/refractory CLL with 420 mg daily; exclude other approved indications and treatment-naive patients. | — | — | — |
| 9801883 | 2031-06-03 | U U-2243 | N | N | SUBPOPULATION_USE | — | — | — |
| 9801883 | 2031-06-03 | U U-2159 | N | N | SUBPOPULATION_USE | — | — | — |
| 9801883 | 2031-06-03 | U U-2243 | N | N | SUBPOPULATION_USE Independent claims require treatment-naive CLL/SLL and 420 mg daily; not the whole current IMBRUVICA scope. | — | — | — |
| 9801883 | 2031-06-03 | U U-2159 | N | N | SUBPOPULATION_USE Independent claims require treatment-naive CLL/SLL and 420 mg daily; not the whole current IMBRUVICA scope. | — | — | — |
| 9814721 | 2031-06-03 | U U-1947 | N | N | WITHDRAWN_INDICATION_USE | — | — | — |
| 9814721 | 2031-06-03 | U U-1947 | N | N | WITHDRAWN_INDICATION_USE Independent claim 1 requires previously treated marginal zone lymphoma and 560 mg daily; this indication is absent from the current label. | — | — | — |
| 10004746 | 2031-12-03 | — — | N | N | LIMITED_USE | — | 2031-12-03 | — |
| 10004746 | 2031-12-03 | PED — | N | N | LIMITED_USE CLL/SLL after at least one prior therapy, 420 mg once daily; does not cover all current ibrutinib indications. | — | — | — |
| 10016435 | 2031-12-03 | — — | N | N | LIMITED_USE | — | 2031-12-03 | — |
| 10016435 | 2031-12-03 | PED — | N | N | LIMITED_USE Treatment-naive Waldenstrom macroglobulinemia at 420 mg daily; excludes other approved indications. | — | — | — |
| 10478439 | 2031-12-03 | — — | N | N | LIMITED_USE | — | 2031-12-03 | — |
| 10478439 | 2031-12-03 | PED — | N | N | LIMITED_USE Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | — | — | — |
| 10653696 | 2031-12-03 | — — | N | N | LIMITED_USE | — | 2031-12-03 | — |
| 10653696 | 2031-12-03 | PED — | N | N | LIMITED_USE Ibrutinib mantle cell lymphoma treatment; this indication is absent from the current approved label. | — | — | — |
| 10751342 | 2031-12-03 | — — | N | N | LIMITED_USE | — | 2031-12-03 | — |
| 10751342 | 2031-12-03 | PED — | N | N | LIMITED_USE Relapsed/refractory CLL/SLL 420 mg daily with defined response/progression criteria; excludes other indications. | — | — | — |
| 8754090 | 2031-12-03 | — — | N | N | LIMITED_USE | — | 2031-12-03 | — |
| 8754090 | 2031-12-03 | PED — | N | N | LIMITED_USE Ibrutinib after prior therapy for mantle cell lymphoma, an indication absent from the current approved label. | — | — | — |
| 8999999 | 2031-12-03 | — — | N | N | LIMITED_USE | — | 2031-12-03 | — |
| 8999999 | 2031-12-03 | PED — | N | N | LIMITED_USE Ibrutinib for relapsed/refractory CLL/SLL at specified oral daily doses; excludes other approved indications. | — | — | — |
| 9125889 | 2031-12-03 | — — | N | N | LIMITED_USE | — | 2031-12-03 | — |
| 9125889 | 2031-12-03 | PED — | N | N | LIMITED_USE Ibrutinib for previously treated Waldenstrom macroglobulinemia; excludes treatment-naive WM and other indications. | — | — | — |
| 9801881 | 2031-12-03 | — — | N | N | SUBPOPULATION_USE | — | 2031-12-03 | — |
| 9801881 | 2031-12-03 | PED — | N | N | SUBPOPULATION_USE Claims 1 and 3 require previously treated or relapsed/refractory CLL with 420 mg daily; exclude other approved indications and treatment-naive patients. | — | — | — |
| 9801883 | 2031-12-03 | — — | N | N | SUBPOPULATION_USE | — | 2031-12-03 | — |
| 9801883 | 2031-12-03 | PED — | N | N | SUBPOPULATION_USE Independent claims require treatment-naive CLL/SLL and 420 mg daily; not the whole current IMBRUVICA scope. | — | — | — |
| 9814721 | 2031-12-03 | — — | N | N | WITHDRAWN_INDICATION_USE | — | 2031-12-03 | — |
| 9814721 | 2031-12-03 | PED — | N | N | WITHDRAWN_INDICATION_USE Independent claim 1 requires previously treated marginal zone lymphoma and 560 mg daily; this indication is absent from the current label. | — | — | — |
| 10106548 | 2033-06-03 | DS/DP — | N | N | CRYSTAL | — | — | — |
| 10106548 | 2033-06-03 | DS/DP — | N | N | CRYSTAL Crystalline ibrutinib defined by DSC peak about 157 C. | — | — | — |
| 10125140 | 2033-06-03 | DS/DP — | N | N | CRYSTAL | — | — | — |
| 10125140 | 2033-06-03 | DS/DP — | N | N | CRYSTAL Ibrutinib crystal defined by XRPD peaks 16.1, 18.9 and 21.6 degrees. | — | — | — |
| 10961251 | 2033-06-03 | DP — | N | N | CRYSTAL_PROCESS | — | — | — |
| 10961251 | 2033-06-03 | DP — | N | N | CRYSTAL_PROCESS Ibrutinib crystalline composition restricted by specified precursor XRPD peaks and alcohol-based process. | — | — | — |
| 9725455 | 2033-06-03 | DS — | N | N | CRYSTAL | — | — | — |
| 9725455 | 2033-06-03 | DS — | N | N | CRYSTAL Ibrutinib Form A defined by XRPD peaks 5.7, 18.9 and 21.3 degrees. | — | — | — |
| 9296753 | 2033-10-30 | DS — | N | N | CRYSTAL_FORMULATION | — | — | — |
| 9296753 | 2033-10-30 | DS — | N | N | CRYSTAL_FORMULATION Ibrutinib Form A defined by XRPD, with additional 140 mg/excipient embodiments. USPTO corrections retained; no unrestricted molecule claim. | — | — | — |
| 10106548 | 2033-12-03 | — — | N | N | CRYSTAL | — | 2033-12-03 | — |
| 10106548 | 2033-12-03 | PED — | N | N | CRYSTAL Crystalline ibrutinib defined by DSC peak about 157 C. | — | — | — |
| 10125140 | 2033-12-03 | — — | N | N | CRYSTAL | — | 2033-12-03 | — |
| 10125140 | 2033-12-03 | PED — | N | N | CRYSTAL Ibrutinib crystal defined by XRPD peaks 16.1, 18.9 and 21.6 degrees. | — | — | — |
| 10961251 | 2033-12-03 | — — | N | N | CRYSTAL_PROCESS | — | 2033-12-03 | — |
| 10961251 | 2033-12-03 | PED — | N | N | CRYSTAL_PROCESS Ibrutinib crystalline composition restricted by specified precursor XRPD peaks and alcohol-based process. | — | — | — |
| 9725455 | 2033-12-03 | — — | N | N | CRYSTAL | — | 2033-12-03 | — |
| 9725455 | 2033-12-03 | PED — | N | N | CRYSTAL Ibrutinib Form A defined by XRPD peaks 5.7, 18.9 and 21.3 degrees. | — | — | — |
| 9296753 | 2034-04-30 | — — | N | N | CRYSTAL_FORMULATION | — | 2034-04-30 | — |
| 9296753 | 2034-04-30 | PED — | N | N | CRYSTAL_FORMULATION Ibrutinib Form A defined by XRPD, with additional 140 mg/excipient embodiments. USPTO corrections retained; no unrestricted molecule claim. | — | — | — |
| 10463668 | 2034-10-24 | U U-2654 | N | N | LIMITED_USE | — | — | — |
| 10463668 | 2034-10-24 | U U-2654 | N | N | LIMITED_USE Adult refractory cGVHD at 420 mg with complete response; excludes pediatric cGVHD and malignant indications. | — | — | — |
| 10695350 | 2034-10-24 | U U-2846 | N | N | LIMITED_USE | — | — | — |
| 10695350 | 2034-10-24 | U U-2846 | N | N | LIMITED_USE Adult refractory cGVHD with complete response and discontinuation; not all approved ibrutinib uses. | — | — | — |
| 9795604 | 2034-10-24 | U U-2969 | N | N | PARTIAL_INDICATION_USE | — | — | — |
| 9795604 | 2034-10-24 | U U-2970 | N | N | PARTIAL_INDICATION_USE | — | — | — |
| 9795604 | 2034-10-24 | U U-2969 | N | N | PARTIAL_INDICATION_USE cGVHD claims cover only one current indication. USPTO IPR certificate cancels claims 1, 6-10, 24, 35, 39 and 55; cancelled claims excluded. Surviving claims remain available for a combination assessment. | — | — | — |
| 9795604 | 2034-10-24 | U U-2970 | N | N | PARTIAL_INDICATION_USE cGVHD claims cover only one current indication. USPTO IPR certificate cancels claims 1, 6-10, 24, 35, 39 and 55; cancelled claims excluded. Surviving claims remain available for a combination assessment. | — | — | — |
| 10463668 | 2035-04-24 | — — | N | N | LIMITED_USE | — | 2035-04-24 | — |
| 10463668 | 2035-04-24 | PED — | N | N | LIMITED_USE Adult refractory cGVHD at 420 mg with complete response; excludes pediatric cGVHD and malignant indications. | — | — | — |
| 10695350 | 2035-04-24 | — — | N | N | LIMITED_USE | — | 2035-04-24 | — |
| 10695350 | 2035-04-24 | PED — | N | N | LIMITED_USE Adult refractory cGVHD with complete response and discontinuation; not all approved ibrutinib uses. | — | — | — |
| 9795604 | 2035-04-24 | — — | N | N | PARTIAL_INDICATION_USE | — | 2035-04-24 | — |
| 9795604 | 2035-04-24 | PED — | N | N | PARTIAL_INDICATION_USE cGVHD claims cover only one current indication. USPTO IPR certificate cancels claims 1, 6-10, 24, 35, 39 and 55; cancelled claims excluded. Surviving claims remain available for a combination assessment. | — | — | — |
| 10010507 | 2036-03-03 | DP — | N | N | FORMULATION | — | — | — |
| 10010507 | 2036-03-03 | DP — | N | N | FORMULATION Micronized ibrutinib solid tablets at specified strengths and excipient/physical limitations. | — | — | — |
| 10213386 | 2036-03-03 | DP — | N | N | FORMULATION | — | — | — |
| 10213386 | 2036-03-03 | DP — | N | N | FORMULATION High-load ibrutinib tablet with quantitative pharmacokinetic limitations. | — | — | — |
| 10828259 | 2036-03-03 | DP — | N | N | FORMULATION | — | — | — |
| 10828259 | 2036-03-03 | DP — | N | N | FORMULATION Ibrutinib tablet 60-75 percent loading with specific intra/extragranular excipient restrictions. | — | — | — |
| 9655857 | 2036-03-03 | DP — | N | N | FORMULATION | — | — | — |
| 9655857 | 2036-03-03 | DP — | N | N | FORMULATION Independent claims require high-load ibrutinib tablets with specified excipients and weight percentages; corrected claims do not remove formulation restrictions. | — | — | — |
| 10010507 | 2036-09-03 | — — | N | N | FORMULATION | — | 2036-09-03 | — |
| 10010507 | 2036-09-03 | PED — | N | N | FORMULATION Micronized ibrutinib solid tablets at specified strengths and excipient/physical limitations. | — | — | — |
| 10213386 | 2036-09-03 | — — | N | N | FORMULATION | — | 2036-09-03 | — |
| 10213386 | 2036-09-03 | PED — | N | N | FORMULATION High-load ibrutinib tablet with quantitative pharmacokinetic limitations. | — | — | — |
| 10828259 | 2036-09-03 | — — | N | N | FORMULATION | — | 2036-09-03 | — |
| 10828259 | 2036-09-03 | PED — | N | N | FORMULATION Ibrutinib tablet 60-75 percent loading with specific intra/extragranular excipient restrictions. | — | — | — |
| 9655857 | 2036-09-03 | — — | N | N | FORMULATION | — | 2036-09-03 | — |
| 9655857 | 2036-09-03 | PED — | N | N | FORMULATION Independent claims require high-load ibrutinib tablets with specified excipients and weight percentages; corrected claims do not remove formulation restrictions. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2013-11-13 | 2018-11-13 | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Y | Y | 2018-11-13 | ODE* + ODE-405 + NPP + PED
Full coverage date: 2018-11-13
| Source |
| D-176 | 2018-08-24 | 2021-08-24 | IBRUTINIB IN COMBINATION WITH RITUXIMAB | N | N | — | ODE* + ODE-405 + NPP + PED
Full coverage date: —
| Source |
| M-236 | 2019-01-25 | 2022-01-25 | INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB | N | N | — | ODE* + ODE-405 + NPP + PED
Full coverage date: —
| Source |
| ODE* | 2017-08-02 | 2024-08-02 | Derivative approval restriction tied to original adult cGVHD ODE for ibrutinib through 2024-08-02. This NDA was not independently awarded that ODE; includes no CLL/SLL or WM coverage. | N | N | — | ODE* + ODE-405 + NPP + PED
Full coverage date: —
| Source |
| M-14 | 2022-08-24 | 2025-08-24 | Pediatric clinical-study labeling associated with the 2022-08-24 action; historical code observation with the same end date as the later NPP listing, not independent whole-product coverage. | N | N | — | ODE* + ODE-405 + NPP + PED
Full coverage date: —
| Source |
| NPP | 2022-08-24 | 2025-08-24 | Pediatric cGVHD age 1 year and older after prior systemic therapy; adult cGVHD, CLL/SLL and WM are not covered. | N | N | — | ODE* + ODE-405 + NPP + PED
Full coverage date: —
| Source |
| NPP | 2022-08-24 | 2025-08-24 | Pediatric cGVHD age 1 year and older after prior systemic therapy; adult cGVHD, CLL/SLL and WM are not covered. | N | N | — | ODE* + ODE-405 + NPP + PED
Full coverage date: —
| Source |
| PED | 2025-08-24 | 2026-02-24 | Six-month extension of M-14, NPP: Pediatric clinical-study labeling associated with the 2022-08-24 action; historical code observation with the same end date as the later NPP listing, not independent whole-product coverage. | N | N | — | ODE* + ODE-405 + NPP + PED
Full coverage date: —
| Source |
| PED | 2025-08-24 | 2026-02-24 | Six-month extension of M-14, NPP: Pediatric clinical-study labeling associated with the 2022-08-24 action; historical code observation with the same end date as the later NPP listing, not independent whole-product coverage. | N | N | — | ODE* + ODE-405 + NPP + PED
Full coverage date: —
| Source |
| ODE-405 | 2022-08-24 | 2029-08-24 | TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY | N | N | — | ODE* + ODE-405 + NPP + PED
Full coverage date: —
| Source |
| ODE-405 | 2022-08-24 | 2029-08-24 | TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY | N | N | — | ODE* + ODE-405 + NPP + PED
Full coverage date: —
| Source |
| PED | 2029-08-24 | 2030-02-24 | Six-month extension of ODE-405: TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY | N | N | — | ODE* + ODE-405 + NPP + PED
Full coverage date: —
| Source |
| PED | 2029-08-24 | 2030-02-24 | Six-month extension of ODE-405: TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY | N | N | — | ODE* + ODE-405 + NPP + PED
Full coverage date: —
| Source |
2026-10-11 · CURRENT_AND_HISTORICAL_RECORDS · Historical coverage: NOT_COMPLETE
2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| 212763 / 004 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | ALVOGEN PINE BROOK | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214296 / 004 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | ZYDUS WORLDWIDE DMCC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 215464 / 004 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | SANDOZ INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
Market Entry Information
API filings, authorized generics and linked regulatory milestones.
API Master Files & Certifications 0 records
Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.
| API | Holder / manufacturer | Holder country | Filing type | Number | Status | Filed date | Available for reference | Source | Last verified |
|---|---|---|---|---|---|---|---|---|---|
| No master-file or certification records are linked through public manufacturer portfolios. | |||||||||
Authorized Generics 0 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No authorized-generic records are linked to this product. | ||||||
Tentative ANDA Approvals 0 records
Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.
| Application / product | Applicant | Event / status | Tentative date | Follow-up final approval | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|---|
| No tentative-approval records are linked to this product. | |||||||
Paragraph IV Challenges 0 records
Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.
| Application / product | Applicant | Event / status | Certification event date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No structured Paragraph IV certification events are linked in the available approval evidence. | ||||||
Final ANDA Approvals 0 records
Approval dates do not establish commercial launch. Product mapping is shown for each linked record.
| Application / product | Applicant | Event / status | Final approval date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No final-approval records are linked to this product. | ||||||
Decision evidence (120)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-12-28 | LISTING_CONTEXT | Independent claim 1 visually claims the ibrutinib molecular structure without stereochemical, crystal, formulation or indication restriction; includes the approved R enantiomer. Claim 3 separately claims the opposite enantiomer and was not used as the anchor. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Independent claims 1 and 11 define irreversible BTK inhibitor compound genera including ibrutinib; no crystal, formulation or indication limits. Chemical genera and corrected structures visually checked. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ibrutinib/genus leukemia treatment; not all current malignancy and cGVHD indications. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ibrutinib/genus treatment of lymphoma; excludes the full approved cGVHD and other non-lymphoma scopes. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Independent Formula A genus includes ibrutinib scaffold and nitrogen heterocycle/Michael acceptor; visually checked and unrestricted by crystal, formulation or disease. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ibrutinib/genus treatment of lymphoma; excludes the full approved cGVHD and other non-lymphoma scopes. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Independent Formula D genus includes ibrutinib with phenoxy, piperidine, carbonyl and terminal alkene substituents. Corrected species structures visually checked; no crystal/formulation/indication restriction. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ibrutinib/genus leukemia treatment; not all current malignancy and cGVHD indications. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Independent claim 21 broadly requires ibrutinib and a pharmaceutically acceptable excipient, without specified form, dose or release mechanism; spans all product indications. It is a composition claim rather than new-molecule TrueDS. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ibrutinib/genus treatment of lymphoma; excludes the full approved cGVHD and other non-lymphoma scopes. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ibrutinib/genus treatment of lymphoma; excludes the full approved cGVHD and other non-lymphoma scopes. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Independent compound genus includes ibrutinib pyrazolopyrimidine, phenoxyphenyl, piperidine and Michael-acceptor substituents. Structure visually checked; no formulation or indication restriction. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Ibrutinib/genus treatment of lymphoma; excludes the full approved cGVHD and other non-lymphoma scopes. | Source |
| PATENT | 2027-04-26 | LISTING_CONTEXT | Ibrutinib/genus plus anticancer agent for B-cell proliferative disease/myeloma; does not cover monotherapy and cGVHD. | Source |
| PATENT | 2027-04-26 | LISTING_CONTEXT | Ibrutinib/genus plus anticancer agent for B-cell proliferative disease/myeloma; does not cover monotherapy and cGVHD. | Source |
| PATENT | 2027-04-26 | LISTING_CONTEXT | Ibrutinib/genus plus anticancer agent for B-cell proliferative disease/myeloma; does not cover monotherapy and cGVHD. | Source |
| PATENT | 2027-04-26 | LISTING_CONTEXT | Ibrutinib/genus plus anticancer agent for B-cell proliferative disease/myeloma; does not cover monotherapy and cGVHD. | Source |
| PATENT | 2027-04-26 | LISTING_CONTEXT | Ibrutinib/genus plus anticancer agent for B-cell proliferative disease/myeloma; does not cover monotherapy and cGVHD. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Independent compound genus includes ibrutinib pyrazolopyrimidine, phenoxyphenyl, piperidine and Michael-acceptor substituents. Structure visually checked; no formulation or indication restriction. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Ibrutinib/genus treatment of lymphoma; excludes the full approved cGVHD and other non-lymphoma scopes. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Independent Formula A genus includes ibrutinib scaffold and nitrogen heterocycle/Michael acceptor; visually checked and unrestricted by crystal, formulation or disease. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Independent claim 21 broadly requires ibrutinib and a pharmaceutically acceptable excipient, without specified form, dose or release mechanism; spans all product indications. It is a composition claim rather than new-molecule TrueDS. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Ibrutinib/genus treating blood-cell cancer; not full approved cGVHD and malignant indication scope. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Ibrutinib/genus leukemia treatment; not all current malignancy and cGVHD indications. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Irreversible BTK inhibitor/ibrutinib treatment of B-cell proliferative disorders; not full cGVHD indication coverage. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Independent claim 1 visually claims the ibrutinib molecular structure without stereochemical, crystal, formulation or indication restriction; includes the approved R enantiomer. Claim 3 separately claims the opposite enantiomer and was not used as the anchor. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Independent Formula D genus includes ibrutinib with phenoxy, piperidine, carbonyl and terminal alkene substituents. Corrected species structures visually checked; no crystal/formulation/indication restriction. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Independent claims 1 and 11 define irreversible BTK inhibitor compound genera including ibrutinib; no crystal, formulation or indication limits. Chemical genera and corrected structures visually checked. | Source |
| PATENT | 2027-10-26 | LISTING_CONTEXT | Ibrutinib/genus plus anticancer agent for B-cell proliferative disease/myeloma; does not cover monotherapy and cGVHD. | Source |
| PATENT | 2027-11-13 | LISTING_CONTEXT | Independent compound genus includes ibrutinib; exact ibrutinib name appears in dependent claim 10 as corrected. Genus structure and correction visually checked; no crystal/formulation/indication restriction. | Source |
| PATENT | 2028-05-13 | CANONICAL_ANCHOR | Independent compound genus includes ibrutinib; exact ibrutinib name appears in dependent claim 10 as corrected. Genus structure and correction visually checked; no crystal/formulation/indication restriction. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | CLL/SLL after at least one prior therapy, 420 mg once daily; does not cover all current ibrutinib indications. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Claims 1 and 3 require previously treated or relapsed/refractory CLL with 420 mg daily; exclude other approved indications and treatment-naive patients. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Ibrutinib for previously treated Waldenstrom macroglobulinemia; excludes treatment-naive WM and other indications. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Claims 1 and 3 require previously treated or relapsed/refractory CLL with 420 mg daily; exclude other approved indications and treatment-naive patients. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Relapsed/refractory CLL/SLL 420 mg daily with defined response/progression criteria; excludes other indications. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Relapsed/refractory CLL/SLL 420 mg daily with defined response/progression criteria; excludes other indications. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Relapsed/refractory CLL/SLL 420 mg daily with defined response/progression criteria; excludes other indications. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Ibrutinib mantle cell lymphoma treatment; this indication is absent from the current approved label. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Ibrutinib for relapsed/refractory CLL/SLL at specified oral daily doses; excludes other approved indications. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Independent claims require treatment-naive CLL/SLL and 420 mg daily; not the whole current IMBRUVICA scope. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Ibrutinib after prior therapy for mantle cell lymphoma, an indication absent from the current approved label. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Ibrutinib for relapsed/refractory CLL/SLL at specified oral daily doses; excludes other approved indications. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Ibrutinib for relapsed/refractory CLL/SLL at specified oral daily doses; excludes other approved indications. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Treatment-naive Waldenstrom macroglobulinemia at 420 mg daily; excludes other approved indications. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Independent claims require treatment-naive CLL/SLL and 420 mg daily; not the whole current IMBRUVICA scope. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | CLL/SLL after at least one prior therapy, 420 mg once daily; does not cover all current ibrutinib indications. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Independent claim 1 requires previously treated marginal zone lymphoma and 560 mg daily; this indication is absent from the current label. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | CLL/SLL after at least one prior therapy, 420 mg once daily; does not cover all current ibrutinib indications. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Relapsed/refractory CLL/SLL 420 mg daily with defined response/progression criteria; excludes other indications. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | CLL/SLL after at least one prior therapy, 420 mg once daily; does not cover all current ibrutinib indications. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | Ibrutinib for relapsed/refractory CLL/SLL at specified oral daily doses; excludes other approved indications. | Source |
| PATENT | 2031-12-03 | FTO_TAIL | Claims 1 and 3 require previously treated or relapsed/refractory CLL with 420 mg daily; exclude other approved indications and treatment-naive patients. | Source |
| PATENT | 2031-12-03 | FTO_TAIL | Continuous ibrutinib for B-cell proliferative disease with exposure/BTK occupancy limits; excludes cGVHD scope. | Source |
| PATENT | 2031-12-03 | FTO_TAIL | Ibrutinib mantle cell lymphoma treatment; this indication is absent from the current approved label. | Source |
| PATENT | 2031-12-03 | FTO_TAIL | Independent claim 1 requires previously treated marginal zone lymphoma and 560 mg daily; this indication is absent from the current label. | Source |
| PATENT | 2031-12-03 | FTO_TAIL | Ibrutinib for previously treated Waldenstrom macroglobulinemia; excludes treatment-naive WM and other indications. | Source |
| PATENT | 2031-12-03 | FTO_TAIL | Relapsed/refractory CLL/SLL 420 mg daily with defined response/progression criteria; excludes other indications. | Source |
| PATENT | 2031-12-03 | FTO_TAIL | Treatment-naive Waldenstrom macroglobulinemia at 420 mg daily; excludes other approved indications. | Source |
| PATENT | 2031-12-03 | FTO_TAIL | Independent claims require treatment-naive CLL/SLL and 420 mg daily; not the whole current IMBRUVICA scope. | Source |
| PATENT | 2031-12-03 | FTO_TAIL | Ibrutinib for relapsed/refractory CLL/SLL at specified oral daily doses; excludes other approved indications. | Source |
| PATENT | 2031-12-03 | FTO_TAIL | CLL/SLL after at least one prior therapy, 420 mg once daily; does not cover all current ibrutinib indications. | Source |
| PATENT | 2031-12-03 | FTO_TAIL | Ibrutinib after prior therapy for mantle cell lymphoma, an indication absent from the current approved label. | Source |
| PATENT | 2033-06-03 | FTO_TAIL | Ibrutinib crystal defined by XRPD peaks 16.1, 18.9 and 21.6 degrees. | Source |
| PATENT | 2033-06-03 | FTO_TAIL | Ibrutinib Form A defined by XRPD peaks 5.7, 18.9 and 21.3 degrees. | Source |
| PATENT | 2033-06-03 | FTO_TAIL | Crystalline ibrutinib defined by DSC peak about 157 C. | Source |
| PATENT | 2033-06-03 | FTO_TAIL | Ibrutinib crystalline composition restricted by specified precursor XRPD peaks and alcohol-based process. | Source |
| PATENT | 2033-10-30 | FTO_TAIL | Ibrutinib Form A defined by XRPD, with additional 140 mg/excipient embodiments. USPTO corrections retained; no unrestricted molecule claim. | Source |
| PATENT | 2033-12-03 | FTO_TAIL | Crystalline ibrutinib defined by DSC peak about 157 C. | Source |
| PATENT | 2033-12-03 | FTO_TAIL | Ibrutinib crystal defined by XRPD peaks 16.1, 18.9 and 21.6 degrees. | Source |
| PATENT | 2033-12-03 | FTO_TAIL | Ibrutinib Form A defined by XRPD peaks 5.7, 18.9 and 21.3 degrees. | Source |
| PATENT | 2033-12-03 | FTO_TAIL | Ibrutinib crystalline composition restricted by specified precursor XRPD peaks and alcohol-based process. | Source |
| PATENT | 2034-04-30 | FTO_TAIL | Ibrutinib Form A defined by XRPD, with additional 140 mg/excipient embodiments. USPTO corrections retained; no unrestricted molecule claim. | Source |
| PATENT | 2034-10-24 | FTO_TAIL | Adult refractory cGVHD with complete response and discontinuation; not all approved ibrutinib uses. | Source |
| PATENT | 2034-10-24 | FTO_TAIL | cGVHD claims cover only one current indication. USPTO IPR certificate cancels claims 1, 6-10, 24, 35, 39 and 55; cancelled claims excluded. Surviving claims remain available for a combination assessment. | Source |
| PATENT | 2034-10-24 | FTO_TAIL | cGVHD claims cover only one current indication. USPTO IPR certificate cancels claims 1, 6-10, 24, 35, 39 and 55; cancelled claims excluded. Surviving claims remain available for a combination assessment. | Source |
| PATENT | 2034-10-24 | FTO_TAIL | Adult refractory cGVHD at 420 mg with complete response; excludes pediatric cGVHD and malignant indications. | Source |
| PATENT | 2035-04-24 | FTO_TAIL | cGVHD claims cover only one current indication. USPTO IPR certificate cancels claims 1, 6-10, 24, 35, 39 and 55; cancelled claims excluded. Surviving claims remain available for a combination assessment. | Source |
| PATENT | 2035-04-24 | FTO_TAIL | Adult refractory cGVHD with complete response and discontinuation; not all approved ibrutinib uses. | Source |
| PATENT | 2035-04-24 | FTO_TAIL | Adult refractory cGVHD at 420 mg with complete response; excludes pediatric cGVHD and malignant indications. | Source |
| PATENT | 2036-03-03 | FTO_TAIL | High-load ibrutinib tablet with quantitative pharmacokinetic limitations. | Source |
| PATENT | 2036-03-03 | FTO_TAIL | Independent claims require high-load ibrutinib tablets with specified excipients and weight percentages; corrected claims do not remove formulation restrictions. | Source |
| PATENT | 2036-03-03 | FTO_TAIL | Micronized ibrutinib solid tablets at specified strengths and excipient/physical limitations. | Source |
| PATENT | 2036-03-03 | FTO_TAIL | Ibrutinib tablet 60-75 percent loading with specific intra/extragranular excipient restrictions. | Source |
| PATENT | 2036-09-03 | FTO_TAIL | Micronized ibrutinib solid tablets at specified strengths and excipient/physical limitations. | Source |
| PATENT | 2036-09-03 | FTO_TAIL | Independent claims require high-load ibrutinib tablets with specified excipients and weight percentages; corrected claims do not remove formulation restrictions. | Source |
| PATENT | 2036-09-03 | FTO_TAIL | Ibrutinib tablet 60-75 percent loading with specific intra/extragranular excipient restrictions. | Source |
| PATENT | 2036-09-03 | FTO_TAIL | High-load ibrutinib tablet with quantitative pharmacokinetic limitations. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Pediatric cGVHD age 1 year and older after prior systemic therapy; adult cGVHD, CLL/SLL and WM are not covered. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Six-month extension of ODE-405: TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Pediatric clinical-study labeling associated with the 2022-08-24 action; historical code observation with the same end date as the later NPP listing, not independent whole-product coverage. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | IBRUTINIB IN COMBINATION WITH RITUXIMAB | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Six-month extension of M-14, NPP: Pediatric clinical-study labeling associated with the 2022-08-24 action; historical code observation with the same end date as the later NPP listing, not independent whole-product coverage. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Derivative approval restriction tied to original adult cGVHD ODE for ibrutinib through 2024-08-02. This NDA was not independently awarded that ODE; includes no CLL/SLL or WM coverage. | Source |
| REGULATORY_EXCLUSIVITY | 2018-11-13 | SCOPE_CONTEXT | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Source |
| REGULATORY_STATUS | 2023-05-18 | TERMINAL_STATUS | NDA 210563/S-017 removes the 560 mg tablet. FDA approval event 2023-05-18 and letter electronic signature 2023-05-18; web posting date 2023-05-19 is not the event date. Canonical patent/exclusivity assessment is preserved as historical supporting data; it does not override this product status. | Source |
Independent legal-event information
Litigation & Settlement History
Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.
No litigation or settlement record currently linked to this product.