Product profile · United States
IMBRUVICA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Approval letter 211344 explicitly identifies Final approval and the IMBRUVICA 70 mg capsule RLD. Current nonmarketing and historical Final approval are separate facts. Do not copy official DS flags of 2033/34 crystal-form patents into TRUE_DS.
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 claim 1: Formula D; dependent claim 5 explicitly names (R)-ibrutinib. Compound protection without crystal-form/use limitations. | — | — | — |
| 8476284 | 2026-12-28 | U U-1650 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8476284 | 2026-12-28 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8476284 | 2026-12-28 | U U-1650 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE BTK inhibitor limited to lymphoma. | — | — | — |
| 8476284 | 2026-12-28 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE BTK inhibitor limited to lymphoma. | — | — | — |
| 8497277 | 2026-12-28 | U U-2241 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8497277 | 2026-12-28 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8497277 | 2026-12-28 | U U-1491 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8497277 | 2026-12-28 | U U-2242 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8497277 | 2026-12-28 | U U-1650 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8497277 | 2026-12-28 | U U-3422 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8497277 | 2026-12-28 | U U-1491 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Limited to B-cell proliferative disorders. | — | — | — |
| 8497277 | 2026-12-28 | U U-2241 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Limited to B-cell proliferative disorders. | — | — | — |
| 8497277 | 2026-12-28 | U U-3422 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Limited to B-cell proliferative disorders. | — | — | — |
| 8497277 | 2026-12-28 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Limited to B-cell proliferative disorders. | — | — | — |
| 8497277 | 2026-12-28 | U U-2242 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Limited to B-cell proliferative disorders. | — | — | — |
| 8497277 | 2026-12-28 | U U-1650 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Limited to B-cell proliferative disorders. | — | — | — |
| 8697711 | 2026-12-28 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 8697711 | 2026-12-28 | DS/DP — | Y | Y | TRUE_DS Verified claims 1-13 and certificate of correction on USPTO PDF pages 68-70. Independent claim 1 directly claims the phenoxyphenyl-pyrazolopyrimidine/piperidine/acrylamide structure of ibrutinib without stereochemical restriction, including (R)-ibrutinib; claim 2 broadly claims compositions. Claim 3 specifies the depicted stereoisomer, and claims 5-13 include synthesis processes distinct from the substance protection in claim 1. No specific crystal-form, formulation, or indication limitation: TRUE_DS Y; DS-equivalent Y. | — | — | — |
| 8703780 | 2026-12-28 | U U-1491 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8703780 | 2026-12-28 | U U-1491 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Limited to leukemia. | — | — | — |
| 8735403 | 2026-12-28 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 8735403 | 2026-12-28 | DS/DP — | Y | Y | TRUE_DS Irreversible BTK inhibitor Formula A/Cys481 binding, a compound genus. Final structural-image correspondence with the product requires further verification. | — | — | — |
| 8754091 | 2026-12-28 | DP — | N | Y | DS_EQUIVALENT | — | — | — |
| 8754091 | 2026-12-28 | DP — | N | Y | DS_EQUIVALENT Independent claim 1: Formula A BTK inhibitor plus permitted excipient; capsule/excipient ratios appear only in dependent claims. Broad-composition DS-equivalent provisional classification. | — | — | — |
| 8952015 | 2026-12-28 | U U-1491 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8952015 | 2026-12-28 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8952015 | 2026-12-28 | U U-1650 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8952015 | 2026-12-28 | U U-1650 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE BTK/ITK inhibitor limited to blood-cell cancer. | — | — | — |
| 8952015 | 2026-12-28 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE BTK/ITK inhibitor limited to blood-cell cancer. | — | — | — |
| 8952015 | 2026-12-28 | U U-1491 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE BTK/ITK inhibitor limited to blood-cell cancer. | — | — | — |
| 8957079 | 2026-12-28 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 8957079 | 2026-12-28 | DS/DP — | Y | Y | TRUE_DS Formula B Michael-acceptor compound genus; final structural-image correspondence requires further verification. | — | — | — |
| 9181257 | 2026-12-28 | DS — | Y | Y | TRUE_DS | — | — | — |
| 9181257 | 2026-12-28 | DS — | Y | Y | TRUE_DS Formula A nitrogen heterocycle/Michael-acceptor compound genus; final structural-image correspondence requires further verification. | — | — | — |
| 8563563 | 2027-04-26 | U U-2219 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8563563 | 2027-04-26 | U U-1491 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8563563 | 2027-04-26 | U U-1650 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8563563 | 2027-04-26 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8563563 | 2027-04-26 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE B-cell disorder/plasma myeloma+second anticancer agent | — | — | — |
| 8563563 | 2027-04-26 | U U-2219 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE B-cell disorder/plasma myeloma+second anticancer agent | — | — | — |
| 8563563 | 2027-04-26 | U U-1650 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE B-cell disorder/plasma myeloma+second anticancer agent | — | — | — |
| 8563563 | 2027-04-26 | U U-1491 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE B-cell disorder/plasma myeloma+second anticancer agent | — | — | — |
| 7514444 | 2027-06-28 | — — | Y | Y | TRUE_DS | — | 2027-06-28 | — |
| 7514444 | 2027-06-28 | PED — | Y | Y | TRUE_DS Independent claim 1: Formula D; dependent claim 5 explicitly names (R)-ibrutinib. Compound protection without crystal-form/use limitations. | — | — | — |
| 8476284 | 2027-06-28 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2027-06-28 | — |
| 8476284 | 2027-06-28 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE BTK inhibitor limited to lymphoma. | — | — | — |
| 8497277 | 2027-06-28 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2027-06-28 | — |
| 8497277 | 2027-06-28 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Limited to B-cell proliferative disorders. | — | — | — |
| 8697711 | 2027-06-28 | — — | Y | Y | TRUE_DS | — | 2027-06-28 | — |
| 8697711 | 2027-06-28 | PED — | Y | Y | TRUE_DS Verified claims 1-13 and certificate of correction on USPTO PDF pages 68-70. Independent claim 1 directly claims the phenoxyphenyl-pyrazolopyrimidine/piperidine/acrylamide structure of ibrutinib without stereochemical restriction, including (R)-ibrutinib; claim 2 broadly claims compositions. Claim 3 specifies the depicted stereoisomer, and claims 5-13 include synthesis processes distinct from the substance protection in claim 1. No specific crystal-form, formulation, or indication limitation: TRUE_DS Y; DS-equivalent Y. | — | — | — |
| 8703780 | 2027-06-28 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2027-06-28 | — |
| 8703780 | 2027-06-28 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Limited to leukemia. | — | — | — |
| 8735403 | 2027-06-28 | — — | Y | Y | TRUE_DS | — | 2027-06-28 | — |
| 8735403 | 2027-06-28 | PED — | Y | Y | TRUE_DS Irreversible BTK inhibitor Formula A/Cys481 binding, a compound genus. Final structural-image correspondence with the product requires further verification. | — | — | — |
| 8754091 | 2027-06-28 | — — | N | Y | DS_EQUIVALENT | — | 2027-06-28 | — |
| 8754091 | 2027-06-28 | PED — | N | Y | DS_EQUIVALENT Independent claim 1: Formula A BTK inhibitor plus permitted excipient; capsule/excipient ratios appear only in dependent claims. Broad-composition DS-equivalent provisional classification. | — | — | — |
| 8952015 | 2027-06-28 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2027-06-28 | — |
| 8952015 | 2027-06-28 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE BTK/ITK inhibitor limited to blood-cell cancer. | — | — | — |
| 8957079 | 2027-06-28 | — — | Y | Y | TRUE_DS | — | 2027-06-28 | — |
| 8957079 | 2027-06-28 | PED — | Y | Y | TRUE_DS Formula B Michael-acceptor compound genus; final structural-image correspondence requires further verification. | — | — | — |
| 9181257 | 2027-06-28 | — — | Y | Y | TRUE_DS | — | 2027-06-28 | — |
| 9181257 | 2027-06-28 | PED — | Y | Y | TRUE_DS Formula A nitrogen heterocycle/Michael-acceptor compound genus; final structural-image correspondence requires further verification. | — | — | — |
| 8563563 | 2027-10-26 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2027-10-26 | — |
| 8563563 | 2027-10-26 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE B-cell disorder/plasma myeloma+second anticancer agent | — | — | — |
| 8008309 | 2027-11-13 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 8008309 | 2027-11-13 | DS/DP — | Y | Y | TRUE_DS Independent claim 1: Formula D; dependent claim 6 explicitly names the ibrutinib scaffold. Compound genus without crystal-form/use limitations. | — | — | — |
| 8008309 | 2028-05-13 | — — | Y | Y | TRUE_DS | — | 2028-05-13 | — |
| 8008309 | 2028-05-13 | PED — | Y | Y | TRUE_DS Independent claim 1: Formula D; dependent claim 6 explicitly names the ibrutinib scaffold. Compound genus without crystal-form/use limitations. | — | — | — |
| 10004746 | 2031-06-03 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10004746 | 2031-06-03 | U U-2242 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10004746 | 2031-06-03 | U U-1684 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10004746 | 2031-06-03 | U U-2241 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10004746 | 2031-06-03 | U U-1684 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE prior-failed/relapsed-refractory CLL/SLL420mg | — | — | — |
| 10004746 | 2031-06-03 | U U-2241 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE prior-failed/relapsed-refractory CLL/SLL420mg | — | — | — |
| 10004746 | 2031-06-03 | U U-2242 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE prior-failed/relapsed-refractory CLL/SLL420mg | — | — | — |
| 10004746 | 2031-06-03 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE prior-failed/relapsed-refractory CLL/SLL420mg | — | — | — |
| 10016435 | 2031-06-03 | U U-1650 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10016435 | 2031-06-03 | U U-1650 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE treatment-naive WM420mg | — | — | — |
| 10478439 | 2031-06-03 | U U-2242 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-1650 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-2241 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-2665 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-3422 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-1684 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10478439 | 2031-06-03 | U U-1650 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | — | — | — |
| 10478439 | 2031-06-03 | U U-2665 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | — | — | — |
| 10478439 | 2031-06-03 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | — | — | — |
| 10478439 | 2031-06-03 | U U-2241 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | — | — | — |
| 10478439 | 2031-06-03 | U U-3422 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | — | — | — |
| 10478439 | 2031-06-03 | U U-1684 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | — | — | — |
| 10478439 | 2031-06-03 | U U-2242 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | — | — | — |
| 10751342 | 2031-06-03 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10751342 | 2031-06-03 | U U-2944 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10751342 | 2031-06-03 | U U-2943 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10751342 | 2031-06-03 | U U-1491 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10751342 | 2031-06-03 | U U-2943 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE CLL/SLL 420 mg continuously until progression/toxicity, with lymphocytosis conditions. | — | — | — |
| 10751342 | 2031-06-03 | U U-1491 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE CLL/SLL 420 mg continuously until progression/toxicity, with lymphocytosis conditions. | — | — | — |
| 10751342 | 2031-06-03 | U U-2944 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE CLL/SLL 420 mg continuously until progression/toxicity, with lymphocytosis conditions. | — | — | — |
| 10751342 | 2031-06-03 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE CLL/SLL 420 mg continuously until progression/toxicity, with lymphocytosis conditions. | — | — | — |
| 11672803 | 2031-06-03 | U U-2242 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 11672803 | 2031-06-03 | U U-1684 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 11672803 | 2031-06-03 | U U-2241 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 11672803 | 2031-06-03 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 11672803 | 2031-06-03 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE CLL/SLL continuous daily treatment conditions. | — | — | — |
| 11672803 | 2031-06-03 | U U-1684 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE CLL/SLL continuous daily treatment conditions. | — | — | — |
| 11672803 | 2031-06-03 | U U-2242 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE CLL/SLL continuous daily treatment conditions. | — | — | — |
| 11672803 | 2031-06-03 | U U-2241 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE CLL/SLL continuous daily treatment conditions. | — | — | — |
| 8999999 | 2031-06-03 | U U-1491 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8999999 | 2031-06-03 | U U-2228 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8999999 | 2031-06-03 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8999999 | 2031-06-03 | U U-2228 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE relapsed/refractory CLL/SLL280–840mg | — | — | — |
| 8999999 | 2031-06-03 | U U-1946 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE relapsed/refractory CLL/SLL280–840mg | — | — | — |
| 8999999 | 2031-06-03 | U U-1491 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE relapsed/refractory CLL/SLL280–840mg | — | — | — |
| 9125889 | 2031-06-03 | U U-1650 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 9125889 | 2031-06-03 | U U-1650 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE previously-treated WM420–840mg | — | — | — |
| 9801881 | 2031-06-03 | U U-1491 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 9801881 | 2031-06-03 | U U-1491 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE failed prior/refractory CLL420mg | — | — | — |
| 9801883 | 2031-06-03 | U U-2159 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 9801883 | 2031-06-03 | U U-2159 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE treatment-naive CLL/SLL420mg | — | — | — |
| 10004746 | 2031-12-03 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2031-12-03 | — |
| 10004746 | 2031-12-03 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE prior-failed/relapsed-refractory CLL/SLL420mg | — | — | — |
| 10016435 | 2031-12-03 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2031-12-03 | — |
| 10016435 | 2031-12-03 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE treatment-naive WM420mg | — | — | — |
| 10478439 | 2031-12-03 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2031-12-03 | — |
| 10478439 | 2031-12-03 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | — | — | — |
| 10751342 | 2031-12-03 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2031-12-03 | — |
| 10751342 | 2031-12-03 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE CLL/SLL 420 mg continuously until progression/toxicity, with lymphocytosis conditions. | — | — | — |
| 8999999 | 2031-12-03 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2031-12-03 | — |
| 8999999 | 2031-12-03 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE relapsed/refractory CLL/SLL280–840mg | — | — | — |
| 9125889 | 2031-12-03 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2031-12-03 | — |
| 9125889 | 2031-12-03 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE previously-treated WM420–840mg | — | — | — |
| 9801881 | 2031-12-03 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2031-12-03 | — |
| 9801881 | 2031-12-03 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE failed prior/refractory CLL420mg | — | — | — |
| 9801883 | 2031-12-03 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2031-12-03 | — |
| 9801883 | 2031-12-03 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE treatment-naive CLL/SLL420mg | — | — | — |
| 10106548 | 2033-06-03 | DS/DP — | N | N | CRYSTALLINE_FORM | — | — | — |
| 10106548 | 2033-06-03 | DS/DP — | N | N | CRYSTALLINE_FORM Ibrutinib crystal form limited by DSC 157 C and XRPD 18.9/5.7/21.3. | — | — | — |
| 10125140 | 2033-06-03 | DS/DP — | N | N | CRYSTALLINE_FORM | — | — | — |
| 10125140 | 2033-06-03 | DS/DP — | N | N | CRYSTALLINE_FORM Ibrutinib Form A limited by XRPD 16.1/18.9/21.6. | — | — | — |
| 10294231 | 2033-06-03 | DP — | N | N | FORMULATION_OR_PK | — | — | — |
| 10294231 | 2033-06-03 | DP — | N | N | FORMULATION_OR_PK ibrutinib40–200mg·diluent40–50%·disintegrant3–10%·surfactant2–7%·lubricant | — | — | — |
| 10294232 | 2033-06-03 | DP — | N | N | FORMULATION_OR_PK | — | — | — |
| 10294232 | 2033-06-03 | DP — | N | N | FORMULATION_OR_PK Ibrutinib 40-200 mg formulation with diluent 40-50% and lubricant 0.2-1.0%. | — | — | — |
| 10961251 | 2033-06-03 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | — | — |
| 10961251 | 2033-06-03 | DP — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS Ibrutinib crystal composition manufactured by combining an alcohol solution with a specified XRPD starting crystal; distinct from the compound itself. | — | — | — |
| 9713617 | 2033-06-03 | DP — | N | N | FORMULATION_OR_PK | — | — | — |
| 9713617 | 2033-06-03 | DP — | N | N | FORMULATION_OR_PK Ibrutinib fixed excipient ratios and blister packaging. | — | — | — |
| 9725455 | 2033-06-03 | DS — | N | N | CRYSTALLINE_FORM | — | — | — |
| 9725455 | 2033-06-03 | DS — | N | N | CRYSTALLINE_FORM Ibrutinib Form A limited by XRPD 5.7/18.9/21.3. | — | — | — |
| 9540382 | 2033-08-18 | U U-1491 | N | N | FORMULATION_OR_PK | — | — | — |
| 9540382 | 2033-08-18 | U U-1946 | N | N | FORMULATION_OR_PK | — | — | — |
| 9540382 | 2033-08-18 | U U-1650 | N | N | FORMULATION_OR_PK | — | — | — |
| 9540382 | 2033-08-18 | U U-1650 | N | N | FORMULATION_OR_PK Cancer treatment using a fixed ibrutinib formulation; full cGVHD coverage is unproven. | — | — | — |
| 9540382 | 2033-08-18 | U U-1946 | N | N | FORMULATION_OR_PK Cancer treatment using a fixed ibrutinib formulation; full cGVHD coverage is unproven. | — | — | — |
| 9540382 | 2033-08-18 | U U-1491 | N | N | FORMULATION_OR_PK Cancer treatment using a fixed ibrutinib formulation; full cGVHD coverage is unproven. | — | — | — |
| 9296753 | 2033-10-30 | DS — | N | N | CRYSTALLINE_FORM | — | — | — |
| 9296753 | 2033-10-30 | DS — | N | N | CRYSTALLINE_FORM Claim 1: ibrutinib Form A/XRPD limitations. | — | — | — |
| 10106548 | 2033-12-03 | — — | N | N | CRYSTALLINE_FORM | — | 2033-12-03 | — |
| 10106548 | 2033-12-03 | PED — | N | N | CRYSTALLINE_FORM Ibrutinib crystal form limited by DSC 157 C and XRPD 18.9/5.7/21.3. | — | — | — |
| 10125140 | 2033-12-03 | — — | N | N | CRYSTALLINE_FORM | — | 2033-12-03 | — |
| 10125140 | 2033-12-03 | PED — | N | N | CRYSTALLINE_FORM Ibrutinib Form A limited by XRPD 16.1/18.9/21.6. | — | — | — |
| 10294231 | 2033-12-03 | — — | N | N | FORMULATION_OR_PK | — | 2033-12-03 | — |
| 10294231 | 2033-12-03 | PED — | N | N | FORMULATION_OR_PK ibrutinib40–200mg·diluent40–50%·disintegrant3–10%·surfactant2–7%·lubricant | — | — | — |
| 10294232 | 2033-12-03 | — — | N | N | FORMULATION_OR_PK | — | 2033-12-03 | — |
| 10294232 | 2033-12-03 | PED — | N | N | FORMULATION_OR_PK Ibrutinib 40-200 mg formulation with diluent 40-50% and lubricant 0.2-1.0%. | — | — | — |
| 10961251 | 2033-12-03 | — — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS | — | 2033-12-03 | — |
| 10961251 | 2033-12-03 | PED — | N | N | FIXED_FORMULATION_OR_PRODUCT_BY_PROCESS Ibrutinib crystal composition manufactured by combining an alcohol solution with a specified XRPD starting crystal; distinct from the compound itself. | — | — | — |
| 9713617 | 2033-12-03 | — — | N | N | FORMULATION_OR_PK | — | 2033-12-03 | — |
| 9713617 | 2033-12-03 | PED — | N | N | FORMULATION_OR_PK Ibrutinib fixed excipient ratios and blister packaging. | — | — | — |
| 9725455 | 2033-12-03 | — — | N | N | CRYSTALLINE_FORM | — | 2033-12-03 | — |
| 9725455 | 2033-12-03 | PED — | N | N | CRYSTALLINE_FORM Ibrutinib Form A limited by XRPD 5.7/18.9/21.3. | — | — | — |
| 9540382 | 2034-02-18 | — — | N | N | FORMULATION_OR_PK | — | 2034-02-18 | — |
| 9540382 | 2034-02-18 | PED — | N | N | FORMULATION_OR_PK Cancer treatment using a fixed ibrutinib formulation; full cGVHD coverage is unproven. | — | — | — |
| 9296753 | 2034-04-30 | — — | N | N | CRYSTALLINE_FORM | — | 2034-04-30 | — |
| 9296753 | 2034-04-30 | PED — | N | N | CRYSTALLINE_FORM PED row inherits the underlying patent classification; do not add another six months to this date. Claim 1: ibrutinib Form A/XRPD limitations. | — | — | — |
| 10463668 | 2034-10-24 | U U-2654 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10463668 | 2034-10-24 | U U-2654 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE adult refractory cGVHD420mg·complete response | — | — | — |
| 10695350 | 2034-10-24 | U U-2846 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10695350 | 2034-10-24 | U U-2846 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Adult refractory cGVHD with complete response/discontinuation and specified prevention. | — | — | — |
| 9795604 | 2034-10-24 | U U-2970 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 9795604 | 2034-10-24 | U U-3422 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 9795604 | 2034-10-24 | U U-2969 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 9795604 | 2034-10-24 | U U-2970 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE BTK inhibitor limited to cGVHD. | — | — | — |
| 9795604 | 2034-10-24 | U U-3422 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE BTK inhibitor limited to cGVHD. | — | — | — |
| 9795604 | 2034-10-24 | U U-2969 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE BTK inhibitor limited to cGVHD. | — | — | — |
| 10463668 | 2035-04-24 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2035-04-24 | — |
| 10463668 | 2035-04-24 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE adult refractory cGVHD420mg·complete response | — | — | — |
| 10695350 | 2035-04-24 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2035-04-24 | — |
| 10695350 | 2035-04-24 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Adult refractory cGVHD with complete response/discontinuation and specified prevention. | — | — | — |
| 9795604 | 2035-04-24 | — — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | 2035-04-24 | — |
| 9795604 | 2035-04-24 | PED — | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE BTK inhibitor limited to cGVHD. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NPP | — | 2025-08-24 | Chronic GVHD extension in pediatric patients aged one year and older and associated PED; does not cover all adult CLL/SLL/WM indications. | N | N | — | Source | |
| NPP | — | 2025-08-24 | Chronic GVHD extension in pediatric patients aged one year and older and associated PED; does not cover all adult CLL/SLL/WM indications. | N | N | — | Source | |
| PED | — | 2026-02-24 | Chronic GVHD extension in pediatric patients aged one year and older and associated PED; does not cover all adult CLL/SLL/WM indications. | N | N | — | Source | |
| PED | — | 2026-02-24 | Chronic GVHD extension in pediatric patients aged one year and older and associated PED; does not cover all adult CLL/SLL/WM indications. | N | N | — | Source | |
| ODE-405 | — | 2029-08-24 | Chronic GVHD extension in pediatric patients aged one year and older and associated PED; does not cover all adult CLL/SLL/WM indications. | N | N | — | Source | |
| ODE-405 | — | 2029-08-24 | Chronic GVHD extension in pediatric patients aged one year and older and associated PED; does not cover all adult CLL/SLL/WM indications. | N | N | — | Source | |
| PED | — | 2030-02-24 | Chronic GVHD extension in pediatric patients aged one year and older and associated PED; does not cover all adult CLL/SLL/WM indications. | N | N | — | Source | |
| PED | — | 2030-02-24 | Chronic GVHD extension in pediatric patients aged one year and older and associated PED; does not cover all adult CLL/SLL/WM indications. | N | N | — | Source |
2026-10-10 · CURRENT_SNAPSHOT_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 |
|---|---|---|---|---|---|---|---|
| 214498 / 001 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | ALVOGEN INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211344 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-03-31 | — | ZYDUS LIFESCIENCES GLOBAL FZE | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 211344 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-03-31 | — | ZYDUS LIFESCIENCES GLOBAL FZE | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 211344 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2021-03-31 | — | ZYDUS LIFESCIENCES GLOBAL FZE | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 211344 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2021-03-31 | — | ZYDUS LIFESCIENCES GLOBAL FZE | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | 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 4 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 |
|---|---|---|---|---|---|---|
| 211344 / 001 | ZYDUS LIFESCIENCES GLOBAL FZE | FINAL_APPROVAL · FINAL_APPROVED | 2021-03-31 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 211344 / 001 | ZYDUS LIFESCIENCES GLOBAL FZE | FINAL_APPROVAL · FINAL_APPROVED | 2021-03-31 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 211344 / 001 | ZYDUS LIFESCIENCES GLOBAL FZE | FINAL_APPROVAL · FINAL_APPROVAL | 2021-03-31 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 211344 / 001 | ZYDUS LIFESCIENCES GLOBAL FZE | FINAL_APPROVAL · FINAL_APPROVAL | 2021-03-31 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
Decision evidence (102)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| GENERIC_APPROVAL | 2021-03-31 | DISQUALIFYING_FINAL_GENERIC | Exact Final ANDA211344/001 -> NDA205552/002 | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Limited to B-cell proliferative disorders. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Limited to B-cell proliferative disorders. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Limited to leukemia. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Irreversible BTK inhibitor Formula A/Cys481 binding, a compound genus. Final structural-image correspondence with the product requires further verification. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Limited to B-cell proliferative disorders. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Formula B Michael-acceptor compound genus; final structural-image correspondence requires further verification. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Limited to B-cell proliferative disorders. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | BTK inhibitor limited to lymphoma. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | BTK inhibitor limited to lymphoma. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Verified claims 1-13 and certificate of correction on USPTO PDF pages 68-70. Independent claim 1 directly claims the phenoxyphenyl-pyrazolopyrimidine/piperidine/acrylamide structure of ibrutinib without stereochemical restriction, including (R)-ibrutinib; claim 2 broadly claims compositions. Claim 3 specifies the depicted stereoisomer, and claims 5-13 include synthesis processes distinct from the substance protection in claim 1. No specific crystal-form, formulation, or indication limitation: TRUE_DS Y; DS-equivalent Y. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Independent claim 1: Formula D; dependent claim 5 explicitly names (R)-ibrutinib. Compound protection without crystal-form/use limitations. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | BTK/ITK inhibitor limited to blood-cell cancer. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | BTK/ITK inhibitor limited to blood-cell cancer. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Independent claim 1: Formula A BTK inhibitor plus permitted excipient; capsule/excipient ratios appear only in dependent claims. Broad-composition DS-equivalent provisional classification. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | BTK/ITK inhibitor limited to blood-cell cancer. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Limited to B-cell proliferative disorders. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Limited to B-cell proliferative disorders. | Source |
| PATENT | 2026-12-28 | LISTING_CONTEXT | Formula A nitrogen heterocycle/Michael-acceptor compound genus; final structural-image correspondence requires further verification. | Source |
| PATENT | 2027-04-26 | LISTING_CONTEXT | B-cell disorder/plasma myeloma+second anticancer agent | Source |
| PATENT | 2027-04-26 | LISTING_CONTEXT | B-cell disorder/plasma myeloma+second anticancer agent | Source |
| PATENT | 2027-04-26 | LISTING_CONTEXT | B-cell disorder/plasma myeloma+second anticancer agent | Source |
| PATENT | 2027-04-26 | LISTING_CONTEXT | B-cell disorder/plasma myeloma+second anticancer agent | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Limited to leukemia. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | BTK/ITK inhibitor limited to blood-cell cancer. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Formula A nitrogen heterocycle/Michael-acceptor compound genus; final structural-image correspondence requires further verification. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Independent claim 1: Formula A BTK inhibitor plus permitted excipient; capsule/excipient ratios appear only in dependent claims. Broad-composition DS-equivalent provisional classification. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Limited to B-cell proliferative disorders. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Verified claims 1-13 and certificate of correction on USPTO PDF pages 68-70. Independent claim 1 directly claims the phenoxyphenyl-pyrazolopyrimidine/piperidine/acrylamide structure of ibrutinib without stereochemical restriction, including (R)-ibrutinib; claim 2 broadly claims compositions. Claim 3 specifies the depicted stereoisomer, and claims 5-13 include synthesis processes distinct from the substance protection in claim 1. No specific crystal-form, formulation, or indication limitation: TRUE_DS Y; DS-equivalent Y. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Independent claim 1: Formula D; dependent claim 5 explicitly names (R)-ibrutinib. Compound protection without crystal-form/use limitations. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Irreversible BTK inhibitor Formula A/Cys481 binding, a compound genus. Final structural-image correspondence with the product requires further verification. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | BTK inhibitor limited to lymphoma. | Source |
| PATENT | 2027-06-28 | LISTING_CONTEXT | Formula B Michael-acceptor compound genus; final structural-image correspondence requires further verification. | Source |
| PATENT | 2027-10-26 | LISTING_CONTEXT | B-cell disorder/plasma myeloma+second anticancer agent | Source |
| PATENT | 2027-11-13 | LISTING_CONTEXT | Independent claim 1: Formula D; dependent claim 6 explicitly names the ibrutinib scaffold. Compound genus without crystal-form/use limitations. | Source |
| PATENT | 2028-05-13 | CANONICAL_ANCHOR | Independent claim 1: Formula D; dependent claim 6 explicitly names the ibrutinib scaffold. Compound genus without crystal-form/use limitations. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | prior-failed/relapsed-refractory CLL/SLL420mg | Source |
| PATENT | 2031-06-03 | FTO_TAIL | B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | relapsed/refractory CLL/SLL280–840mg | Source |
| PATENT | 2031-06-03 | FTO_TAIL | treatment-naive WM420mg | Source |
| PATENT | 2031-06-03 | FTO_TAIL | relapsed/refractory CLL/SLL280–840mg | Source |
| PATENT | 2031-06-03 | FTO_TAIL | CLL/SLL continuous daily treatment conditions. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | previously-treated WM420–840mg | Source |
| PATENT | 2031-06-03 | FTO_TAIL | CLL/SLL continuous daily treatment conditions. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | CLL/SLL 420 mg continuously until progression/toxicity, with lymphocytosis conditions. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | CLL/SLL continuous daily treatment conditions. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | failed prior/refractory CLL420mg | Source |
| PATENT | 2031-06-03 | FTO_TAIL | relapsed/refractory CLL/SLL280–840mg | Source |
| PATENT | 2031-06-03 | FTO_TAIL | B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | prior-failed/relapsed-refractory CLL/SLL420mg | Source |
| PATENT | 2031-06-03 | FTO_TAIL | B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | treatment-naive CLL/SLL420mg | Source |
| PATENT | 2031-06-03 | FTO_TAIL | CLL/SLL continuous daily treatment conditions. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | prior-failed/relapsed-refractory CLL/SLL420mg | Source |
| PATENT | 2031-06-03 | FTO_TAIL | B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | prior-failed/relapsed-refractory CLL/SLL420mg | Source |
| PATENT | 2031-06-03 | FTO_TAIL | CLL/SLL 420 mg continuously until progression/toxicity, with lymphocytosis conditions. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | CLL/SLL 420 mg continuously until progression/toxicity, with lymphocytosis conditions. | Source |
| PATENT | 2031-06-03 | FTO_TAIL | CLL/SLL 420 mg continuously until progression/toxicity, with lymphocytosis conditions. | Source |
| PATENT | 2031-12-03 | FTO_TAIL | failed prior/refractory CLL420mg | Source |
| PATENT | 2031-12-03 | FTO_TAIL | previously-treated WM420–840mg | Source |
| PATENT | 2031-12-03 | FTO_TAIL | relapsed/refractory CLL/SLL280–840mg | Source |
| PATENT | 2031-12-03 | FTO_TAIL | prior-failed/relapsed-refractory CLL/SLL420mg | Source |
| PATENT | 2031-12-03 | FTO_TAIL | CLL/SLL 420 mg continuously until progression/toxicity, with lymphocytosis conditions. | Source |
| PATENT | 2031-12-03 | FTO_TAIL | treatment-naive CLL/SLL420mg | Source |
| PATENT | 2031-12-03 | FTO_TAIL | B-cell proliferative disorder with AUC >100/BTK occupancy >90%; does not cover all cGVHD. | Source |
| PATENT | 2031-12-03 | FTO_TAIL | treatment-naive WM420mg | Source |
| PATENT | 2033-06-03 | FTO_TAIL | Ibrutinib Form A limited by XRPD 5.7/18.9/21.3. | Source |
| PATENT | 2033-06-03 | FTO_TAIL | Ibrutinib crystal form limited by DSC 157 C and XRPD 18.9/5.7/21.3. | Source |
| PATENT | 2033-06-03 | FTO_TAIL | ibrutinib40–200mg·diluent40–50%·disintegrant3–10%·surfactant2–7%·lubricant | Source |
| PATENT | 2033-06-03 | FTO_TAIL | Ibrutinib fixed excipient ratios and blister packaging. | Source |
| PATENT | 2033-06-03 | FTO_TAIL | Ibrutinib Form A limited by XRPD 16.1/18.9/21.6. | Source |
| PATENT | 2033-06-03 | FTO_TAIL | Ibrutinib crystal composition manufactured by combining an alcohol solution with a specified XRPD starting crystal; distinct from the compound itself. | Source |
| PATENT | 2033-06-03 | FTO_TAIL | Ibrutinib 40-200 mg formulation with diluent 40-50% and lubricant 0.2-1.0%. | Source |
| PATENT | 2033-08-18 | FTO_TAIL | Cancer treatment using a fixed ibrutinib formulation; full cGVHD coverage is unproven. | Source |
| PATENT | 2033-08-18 | FTO_TAIL | Cancer treatment using a fixed ibrutinib formulation; full cGVHD coverage is unproven. | Source |
| PATENT | 2033-08-18 | FTO_TAIL | Cancer treatment using a fixed ibrutinib formulation; full cGVHD coverage is unproven. | Source |
| PATENT | 2033-10-30 | FTO_TAIL | Claim 1: ibrutinib Form A/XRPD limitations. | Source |
| PATENT | 2033-12-03 | FTO_TAIL | ibrutinib40–200mg·diluent40–50%·disintegrant3–10%·surfactant2–7%·lubricant | Source |
| PATENT | 2033-12-03 | FTO_TAIL | Ibrutinib Form A limited by XRPD 16.1/18.9/21.6. | Source |
| PATENT | 2033-12-03 | FTO_TAIL | Ibrutinib crystal composition manufactured by combining an alcohol solution with a specified XRPD starting crystal; distinct from the compound itself. | Source |
| PATENT | 2033-12-03 | FTO_TAIL | Ibrutinib 40-200 mg formulation with diluent 40-50% and lubricant 0.2-1.0%. | Source |
| PATENT | 2033-12-03 | FTO_TAIL | Ibrutinib Form A limited by XRPD 5.7/18.9/21.3. | Source |
| PATENT | 2033-12-03 | FTO_TAIL | Ibrutinib fixed excipient ratios and blister packaging. | Source |
| PATENT | 2033-12-03 | FTO_TAIL | Ibrutinib crystal form limited by DSC 157 C and XRPD 18.9/5.7/21.3. | Source |
| PATENT | 2034-02-18 | FTO_TAIL | Cancer treatment using a fixed ibrutinib formulation; full cGVHD coverage is unproven. | Source |
| PATENT | 2034-04-30 | FTO_TAIL | PED row inherits the underlying patent classification; do not add another six months to this date. Claim 1: ibrutinib Form A/XRPD limitations. | Source |
| PATENT | 2034-10-24 | FTO_TAIL | Adult refractory cGVHD with complete response/discontinuation and specified prevention. | Source |
| PATENT | 2034-10-24 | FTO_TAIL | BTK inhibitor limited to cGVHD. | Source |
| PATENT | 2034-10-24 | FTO_TAIL | adult refractory cGVHD420mg·complete response | Source |
| PATENT | 2034-10-24 | FTO_TAIL | BTK inhibitor limited to cGVHD. | Source |
| PATENT | 2034-10-24 | FTO_TAIL | BTK inhibitor limited to cGVHD. | Source |
| PATENT | 2035-04-24 | FTO_TAIL | Adult refractory cGVHD with complete response/discontinuation and specified prevention. | Source |
| PATENT | 2035-04-24 | FTO_TAIL | adult refractory cGVHD420mg·complete response | Source |
| PATENT | 2035-04-24 | FTO_TAIL | BTK inhibitor limited to cGVHD. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Chronic GVHD extension in pediatric patients aged one year and older and associated PED; does not cover all adult CLL/SLL/WM indications. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Chronic GVHD extension in pediatric patients aged one year and older and associated PED; does not cover all adult CLL/SLL/WM indications. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Chronic GVHD extension in pediatric patients aged one year and older and associated PED; does not cover all adult CLL/SLL/WM indications. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Chronic GVHD extension in pediatric patients aged one year and older and associated PED; does not cover all adult CLL/SLL/WM indications. | 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.