Product profile · United States
IMBRUVICA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Exact-product correction: NDA217003/001 IMBRUVICA oral suspension 70mg/mL, approved 2022-08-24, is approved for cGVHD in adults and patients aged 1 year and older after failure of one or more systemic therapies. US9795604 independent claim 1 covers ibrutinib treatment of cGVHD without mandatory adult-only, 420mg, complete-response or tablet restrictions. It covers this exact presentation full approved scope and is DS_EQUIVALENT. FDA directly lists US9795604*PED through 2035-04-24; this supersedes the prior TRUE_DS anchor 2028-05-13. US12201690 formulation patent through 2039-06-14 remains a tail. Final decision: 2035 DEEP_REVIEW. This conclusion does not extend to NDA210563 tablets with additional non-cGVHD indications.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7514444 | 2026-12-28 | DS/DP — | — | — | — | — | — | — |
| 8476284 | 2026-12-28 | U U-3845 | — | — | — | — | — | — |
| 8476284 | 2026-12-28 | U U-3844 | — | — | — | — | — | — |
| 8476284 | 2026-12-28 | U U-3843 | — | — | — | — | — | — |
| 8476284 | 2026-12-28 | ORANGE_BOOK U-3843,U-3844,U-3845 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 8497277 | 2026-12-28 | U U-3844 | — | — | — | — | — | — |
| 8497277 | 2026-12-28 | U U-2970 | — | — | — | — | — | — |
| 8497277 | 2026-12-28 | U U-3422 | — | — | — | — | — | — |
| 8497277 | 2026-12-28 | U U-3842 | — | — | — | — | — | — |
| 8497277 | 2026-12-28 | U U-3845 | — | — | — | — | — | — |
| 8497277 | 2026-12-28 | U U-2666 | — | — | — | — | — | — |
| 8497277 | 2026-12-28 | U U-3843 | — | — | — | — | — | — |
| 8697711 | 2026-12-28 | DS/DP — | — | — | — | — | — | — |
| 8703780 | 2026-12-28 | U U-3842 | — | — | — | — | — | — |
| 8703780 | 2026-12-28 | U U-2666 | — | — | — | — | — | — |
| 8703780 | 2026-12-28 | ORANGE_BOOK U-2666,U-3842 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 8735403 | 2026-12-28 | DS/DP — | — | — | — | — | — | — |
| 8754091 | 2026-12-28 | DP — | — | — | — | — | — | — |
| 8952015 | 2026-12-28 | U U-2666 | — | — | — | — | — | — |
| 8952015 | 2026-12-28 | U U-3843 | — | — | — | — | — | — |
| 8952015 | 2026-12-28 | U U-3844 | — | — | — | — | — | — |
| 8952015 | 2026-12-28 | U U-3845 | — | — | — | — | — | — |
| 8952015 | 2026-12-28 | U U-3842 | — | — | — | — | — | — |
| 8952015 | 2026-12-28 | ORANGE_BOOK U-2666,U-3842,U-3843,U-3844,U-3845 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 8957079 | 2026-12-28 | DS/DP — | — | — | — | — | — | — |
| 9181257 | 2026-12-28 | DS — | — | — | — | — | — | — |
| 8563563 | 2027-04-26 | U U-3843 | — | — | — | — | — | — |
| 8563563 | 2027-04-26 | U U-3845 | — | — | — | — | — | — |
| 8563563 | 2027-04-26 | U U-3842 | — | — | — | — | — | — |
| 8563563 | 2027-04-26 | U U-3844 | — | — | — | — | — | — |
| 8563563 | 2027-04-26 | U U-2666 | — | — | — | — | — | — |
| 8563563 | 2027-04-26 | ORANGE_BOOK U-2666,U-3842,U-3843,U-3844,U-3845 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 7514444 | 2027-06-28 | — — | — | — | — | — | 2027-06-28 | — |
| 7514444 | 2027-06-28 | ORANGE_BOOK — | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2027-06-28 | — |
| 8497277 | 2027-06-28 | — — | — | — | — | — | 2027-06-28 | — |
| 8497277 | 2027-06-28 | ORANGE_BOOK U-2666,U-2970,U-3422,U-3842,U-3843,U-3844,U-3845 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | 2027-06-28 | — |
| 8697711 | 2027-06-28 | — — | — | — | — | — | 2027-06-28 | — |
| 8697711 | 2027-06-28 | ORANGE_BOOK — | N | N | PROCESS Synthetic compound/intermediate and process claims; not used as the molecular anchor. | — | 2027-06-28 | — |
| 8735403 | 2027-06-28 | — — | — | — | — | — | 2027-06-28 | — |
| 8735403 | 2027-06-28 | ORANGE_BOOK — | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2027-06-28 | — |
| 8754091 | 2027-06-28 | — — | — | — | — | — | 2027-06-28 | — |
| 8754091 | 2027-06-28 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2027-06-28 | — |
| 8957079 | 2027-06-28 | — — | — | — | — | — | 2027-06-28 | — |
| 8957079 | 2027-06-28 | ORANGE_BOOK — | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2027-06-28 | — |
| 9181257 | 2027-06-28 | — — | — | — | — | — | 2027-06-28 | — |
| 9181257 | 2027-06-28 | ORANGE_BOOK — | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2027-06-28 | — |
| 8008309 | 2027-11-13 | DS/DP — | — | — | — | — | — | — |
| 8008309 | 2028-05-13 | — — | — | — | — | — | 2028-05-13 | — |
| 8008309 | 2028-05-13 | ORANGE_BOOK — | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2028-05-13 | — |
| 10004746 | 2031-06-03 | U U-3849 | — | — | — | — | — | — |
| 10004746 | 2031-06-03 | U U-3848 | — | — | — | — | — | — |
| 10004746 | 2031-06-03 | U U-3847 | — | — | — | — | — | — |
| 10004746 | 2031-06-03 | U U-3846 | — | — | — | — | — | — |
| 10004746 | 2031-06-03 | ORANGE_BOOK U-3846,U-3847,U-3848,U-3849 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 10016435 | 2031-06-03 | U U-3845 | — | — | — | — | — | — |
| 10016435 | 2031-06-03 | ORANGE_BOOK U-3845 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 10478439 | 2031-06-03 | U U-3845 | — | — | — | — | — | — |
| 10478439 | 2031-06-03 | U U-2666 | — | — | — | — | — | — |
| 10478439 | 2031-06-03 | U U-3844 | — | — | — | — | — | — |
| 10478439 | 2031-06-03 | U U-3843 | — | — | — | — | — | — |
| 10478439 | 2031-06-03 | U U-3422 | — | — | — | — | — | — |
| 10478439 | 2031-06-03 | U U-3842 | — | — | — | — | — | — |
| 10478439 | 2031-06-03 | U U-2970 | — | — | — | — | — | — |
| 10751342 | 2031-06-03 | U U-3842 | — | — | — | — | — | — |
| 10751342 | 2031-06-03 | U U-3843 | — | — | — | — | — | — |
| 10751342 | 2031-06-03 | U U-3844 | — | — | — | — | — | — |
| 10751342 | 2031-06-03 | U U-2666 | — | — | — | — | — | — |
| 10751342 | 2031-06-03 | ORANGE_BOOK U-2666,U-3842,U-3843,U-3844 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 11672803 | 2031-06-03 | U U-2666 | — | — | — | — | — | — |
| 11672803 | 2031-06-03 | U U-3842 | — | — | — | — | — | — |
| 11672803 | 2031-06-03 | U U-3844 | — | — | — | — | — | — |
| 11672803 | 2031-06-03 | U U-3843 | — | — | — | — | — | — |
| 11672803 | 2031-06-03 | ORANGE_BOOK U-2666,U-3842,U-3843,U-3844 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 8999999 | 2031-06-03 | U U-2666 | — | — | — | — | — | — |
| 8999999 | 2031-06-03 | U U-3844 | — | — | — | — | — | — |
| 8999999 | 2031-06-03 | U U-3842 | — | — | — | — | — | — |
| 8999999 | 2031-06-03 | U U-3843 | — | — | — | — | — | — |
| 8999999 | 2031-06-03 | ORANGE_BOOK U-2666,U-3842,U-3843,U-3844 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 9125889 | 2031-06-03 | U U-3845 | — | — | — | — | — | — |
| 9125889 | 2031-06-03 | ORANGE_BOOK U-3845 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 9801881 | 2031-06-03 | U U-3846 | — | — | — | — | — | — |
| 9801881 | 2031-06-03 | U U-3847 | — | — | — | — | — | — |
| 9801881 | 2031-06-03 | ORANGE_BOOK U-3846,U-3847 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 9801883 | 2031-06-03 | U U-3842 | — | — | — | — | — | — |
| 9801883 | 2031-06-03 | U U-3843 | — | — | — | — | — | — |
| 9801883 | 2031-06-03 | U U-3844 | — | — | — | — | — | — |
| 9801883 | 2031-06-03 | U U-2666 | — | — | — | — | — | — |
| 9801883 | 2031-06-03 | ORANGE_BOOK U-2666,U-3842,U-3843,U-3844 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 10478439 | 2031-12-03 | — — | — | — | — | — | 2031-12-03 | — |
| 10478439 | 2031-12-03 | ORANGE_BOOK U-2666,U-2970,U-3422,U-3842,U-3843,U-3844,U-3845 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | 2031-12-03 | — |
| 10106548 | 2033-06-03 | DS/DP — | — | — | — | — | — | — |
| 10125140 | 2033-06-03 | DS/DP — | — | — | — | — | — | — |
| 10961251 | 2033-06-03 | DP — | — | — | — | — | — | — |
| 9725455 | 2033-06-03 | DS — | — | — | — | — | — | — |
| 9296753 | 2033-10-30 | DS — | — | — | — | — | — | — |
| 10106548 | 2033-12-03 | — — | — | — | — | — | 2033-12-03 | — |
| 10106548 | 2033-12-03 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2033-12-03 | — |
| 10125140 | 2033-12-03 | — — | — | — | — | — | 2033-12-03 | — |
| 10125140 | 2033-12-03 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2033-12-03 | — |
| 10961251 | 2033-12-03 | — — | — | — | — | — | 2033-12-03 | — |
| 10961251 | 2033-12-03 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2033-12-03 | — |
| 9725455 | 2033-12-03 | — — | — | — | — | — | 2033-12-03 | — |
| 9725455 | 2033-12-03 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2033-12-03 | — |
| 9296753 | 2034-04-30 | — — | — | — | — | — | 2034-04-30 | — |
| 9296753 | 2034-04-30 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2034-04-30 | — |
| 10463668 | 2034-10-24 | U U-2970 | — | — | — | — | — | — |
| 10463668 | 2034-10-24 | ORANGE_BOOK U-2970 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 10695350 | 2034-10-24 | U U-2970 | — | — | — | — | — | — |
| 10695350 | 2034-10-24 | ORANGE_BOOK U-2970 | N | N | U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | — | — |
| 9795604 | 2034-10-24 | U U-3422 | N | Y | DS_EQUIVALENT | — | — | — |
| 9795604 | 2034-10-24 | U U-2970 | N | Y | DS_EQUIVALENT | — | — | — |
| 9795604 | 2035-04-24 | — — | N | Y | DS_EQUIVALENT | — | 2035-04-24 | — |
| 9795604 | 2035-04-24 | ORANGE_BOOK U-2970,U-3422 | N | Y | DS_EQUIVALENT Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | 2035-04-24 | — |
| 12364698 | 2036-04-06 | DP — | — | — | — | — | — | — |
| 12364698 | 2036-04-06 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | — | — |
| 12201690 | 2039-06-14 | DP — | — | — | — | — | — | — |
| 12201690 | 2039-06-14 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | — | 2025-08-24 | — | — | — | — | Source | |
| NP | — | 2025-08-24 | FDA posted date collected; scope not independently certified; preserved as context/tail. | — | — | — | — | Source |
| PED | — | 2026-02-24 | — | — | — | — | Source | |
| PED | — | 2026-02-24 | FDA posted date collected; scope not independently certified; preserved as context/tail. | — | — | — | — | Source |
| ODE-405 | — | 2029-08-24 | — | — | — | — | Source | |
| ODE-405 | — | 2029-08-24 | FDA posted date collected; scope not independently certified; preserved as context/tail. | — | — | — | — | Source |
| PED | — | 2030-02-24 | — | — | — | — | Source | |
| PED | — | 2030-02-24 | FDA posted date collected; scope not independently certified; preserved as context/tail. | — | — | — | — | Source |
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 |
|---|---|---|---|---|---|---|---|
| No generic approval facts are linked to this product. | |||||||
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 (2)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2035-04-24 | CANONICAL_ANCHOR | Exact-product correction: NDA217003/001 IMBRUVICA oral suspension 70mg/mL, approved 2022-08-24, is approved for cGVHD in adults and patients aged 1 year and older after failure of one or more systemic therapies. US9795604 independent claim 1 covers ibrutinib treatment of cGVHD without mandatory adult-only, 420mg, complete-response or tablet restrictions. It covers this exact presentation full approved scope and is DS_EQUIVALENT. FDA directly lists US9795604*PED through 2035-04-24; this supersedes the prior TRUE_DS anchor 2028-05-13. US12201690 formulation patent through 2039-06-14 remains a tail. Final decision: 2035 DEEP_REVIEW. This conclusion does not extend to NDA210563 tablets with additional non-cGVHD indications. | Source |
| PATENT | 2039-06-14 | FTO_TAIL | Formulation limitations remain DP; date is not a commercial launch authorization. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2035 | DEEP_REVIEW | FINAL | 2035-04-24 | 2026-10-16 13:34:59 |
| N | 2028 | DEEP_REVIEW | FINAL | 2028-05-13 | 2026-10-13 20:15:36 |
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.