Product profile · United States
BRUKINSA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US9447106 c21/22 zanubrutinib. US11884674 BID and US11970500 QD are not crystal-required independent claims; combined-regimen2037 risk retained. CYP3A subset2043 tail.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10570139 | 2034-04-22 | U U-2145 | N | Y | U English description not available. | — | — | — |
| 10570139 | 2034-04-22 | U U-2537 | N | Y | U English description not available. | — | — | — |
| 10570139 | 2034-04-22 | U U-3063 | N | Y | U English description not available. | — | — | — |
| 10570139 | 2034-04-22 | U U-1745 | N | Y | U English description not available. | — | — | — |
| 10570139 | 2034-04-22 | U U-2666 | N | Y | U English description not available. | — | — | — |
| 10570139 | 2034-04-22 | U U-3486 | N | Y | U English description not available. | — | — | — |
| 10570139 | 2034-04-22 | U U-3860 | N | Y | U English description not available. | — | — | — |
| 10570139 | 2034-04-22 | ORANGE_BOOK U-1745;U-2145;U-2537;U-2666;U-3063;U-3486;U-3860 | N | Y | U English description not available. | — | — | — |
| 11142528 | 2034-04-22 | DP/U U-2145 | N | Y | U English description not available. | — | — | — |
| 11142528 | 2034-04-22 | DP/U U-2537 | N | Y | U English description not available. | — | — | — |
| 11142528 | 2034-04-22 | DP/U U-3486 | N | Y | U English description not available. | — | — | — |
| 11142528 | 2034-04-22 | DP/U U-2666 | N | Y | U English description not available. | — | — | — |
| 11142528 | 2034-04-22 | DP/U U-3860 | N | Y | U English description not available. | — | — | — |
| 11142528 | 2034-04-22 | DP/U U-3063 | N | Y | U English description not available. | — | — | — |
| 11142528 | 2034-04-22 | DP/U U-1745 | N | Y | U English description not available. | — | — | — |
| 11142528 | 2034-04-22 | ORANGE_BOOK U-1745;U-2145;U-2537;U-2666;U-3063;U-3486;U-3860 | N | Y | U English description not available. | — | — | — |
| 9447106 | 2034-04-22 | DS/DP/U U-2666 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9447106 | 2034-04-22 | DS/DP/U U-3860 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9447106 | 2034-04-22 | DS/DP/U U-2537 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9447106 | 2034-04-22 | DS/DP/U U-1745 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9447106 | 2034-04-22 | DS/DP/U U-3063 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9447106 | 2034-04-22 | DS/DP/U U-2145 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9447106 | 2034-04-22 | DS/DP/U U-3486 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9447106 | 2034-04-22 | ORANGE_BOOK U-1745;U-2145;U-2537;U-2666;U-3063;U-3486;U-3860 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10927117 | 2037-08-15 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 10927117 | 2037-08-15 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11591340 | 2037-08-15 | U U-2537 | N | N | U English description not available. | — | — | — |
| 11591340 | 2037-08-15 | U U-3063 | N | N | U English description not available. | — | — | — |
| 11591340 | 2037-08-15 | U U-2666 | N | N | U English description not available. | — | — | — |
| 11591340 | 2037-08-15 | U U-3727 | N | N | U English description not available. | — | — | — |
| 11591340 | 2037-08-15 | U U-1745 | N | N | U English description not available. | — | — | — |
| 11591340 | 2037-08-15 | U U-2145 | N | N | U English description not available. | — | — | — |
| 11591340 | 2037-08-15 | U U-3728 | N | N | U English description not available. | — | — | — |
| 11591340 | 2037-08-15 | U U-3729 | N | N | U English description not available. | — | — | — |
| 11591340 | 2037-08-15 | U U-3486 | N | N | U English description not available. | — | — | — |
| 11591340 | 2037-08-15 | ORANGE_BOOK U-1745;U-2145;U-2537;U-2666;U-3063;U-3486;U-3727;U-3728;U-3729 | N | N | U English description not available. | — | — | — |
| 11851437 | 2037-08-15 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 11851437 | 2037-08-15 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11884674 | 2037-08-15 | U U-2145 | N | N | U English description not available. | — | — | — |
| 11884674 | 2037-08-15 | U U-3860 | N | N | U English description not available. | — | — | — |
| 11884674 | 2037-08-15 | U U-1745 | N | N | U English description not available. | — | — | — |
| 11884674 | 2037-08-15 | U U-3486 | N | N | U English description not available. | — | — | — |
| 11884674 | 2037-08-15 | U U-2537 | N | N | U English description not available. | — | — | — |
| 11884674 | 2037-08-15 | U U-2666 | N | N | U English description not available. | — | — | — |
| 11884674 | 2037-08-15 | U U-3063 | N | N | U English description not available. | — | — | — |
| 11884674 | 2037-08-15 | ORANGE_BOOK U-1745;U-2145;U-2537;U-2666;U-3063;U-3486;U-3860 | N | N | U English description not available. | — | — | — |
| 11970500 | 2037-08-15 | U U-3860 | N | N | U English description not available. | — | — | — |
| 11970500 | 2037-08-15 | U U-1745 | N | N | U English description not available. | — | — | — |
| 11970500 | 2037-08-15 | U U-2666 | N | N | U English description not available. | — | — | — |
| 11970500 | 2037-08-15 | U U-3486 | N | N | U English description not available. | — | — | — |
| 11970500 | 2037-08-15 | U U-3063 | N | N | U English description not available. | — | — | — |
| 11970500 | 2037-08-15 | U U-2537 | N | N | U English description not available. | — | — | — |
| 11970500 | 2037-08-15 | U U-2145 | N | N | U English description not available. | — | — | — |
| 11970500 | 2037-08-15 | ORANGE_BOOK U-1745;U-2145;U-2537;U-2666;U-3063;U-3486;U-3860 | N | N | U English description not available. | — | — | — |
| 11701357 | 2039-06-24 | U U-3860 | N | N | U English description not available. | — | — | — |
| 11701357 | 2039-06-24 | ORANGE_BOOK U-3860 | N | N | U English description not available. | — | — | — |
| 12233069 | 2040-06-10 | DP — | N | N | DP English description not available. | — | — | — |
| 12233069 | 2040-06-10 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11786531 | 2043-01-19 | U U-3718 | N | N | U English description not available. | — | — | — |
| 11786531 | 2043-01-19 | U U-3717 | N | N | U English description not available. | — | — | — |
| 11786531 | 2043-01-19 | U U-3715 | N | N | U English description not available. | — | — | — |
| 11786531 | 2043-01-19 | U U-3719 | N | N | U English description not available. | — | — | — |
| 11786531 | 2043-01-19 | U U-3875 | N | N | U English description not available. | — | — | — |
| 11786531 | 2043-01-19 | U U-3720 | N | N | U English description not available. | — | — | — |
| 11786531 | 2043-01-19 | U U-3716 | N | N | U English description not available. | — | — | — |
| 11786531 | 2043-01-19 | ORANGE_BOOK U-3715;U-3716;U-3717;U-3718;U-3719;U-3720;U-3875 | N | N | U English description not available. | — | — | — |
| 11896596 | 2043-01-19 | U U-3716 | N | N | U English description not available. | — | — | — |
| 11896596 | 2043-01-19 | U U-3715 | N | N | U English description not available. | — | — | — |
| 11896596 | 2043-01-19 | U U-3720 | N | N | U English description not available. | — | — | — |
| 11896596 | 2043-01-19 | U U-3719 | N | N | U English description not available. | — | — | — |
| 11896596 | 2043-01-19 | U U-3717 | N | N | U English description not available. | — | — | — |
| 11896596 | 2043-01-19 | U U-3875 | N | N | U English description not available. | — | — | — |
| 11896596 | 2043-01-19 | U U-3718 | N | N | U English description not available. | — | — | — |
| 11896596 | 2043-01-19 | ORANGE_BOOK U-3715;U-3716;U-3717;U-3718;U-3719;U-3720;U-3875 | N | N | U English description not available. | — | — | — |
| 11911386 | 2043-01-19 | U U-3720 | N | N | U English description not available. | — | — | — |
| 11911386 | 2043-01-19 | U U-3719 | N | N | U English description not available. | — | — | — |
| 11911386 | 2043-01-19 | U U-3718 | N | N | U English description not available. | — | — | — |
| 11911386 | 2043-01-19 | U U-3875 | N | N | U English description not available. | — | — | — |
| 11911386 | 2043-01-19 | U U-3715 | N | N | U English description not available. | — | — | — |
| 11911386 | 2043-01-19 | U U-3717 | N | N | U English description not available. | — | — | — |
| 11911386 | 2043-01-19 | U U-3716 | N | N | U English description not available. | — | — | — |
| 11911386 | 2043-01-19 | ORANGE_BOOK U-3715;U-3716;U-3717;U-3718;U-3719;U-3720;U-3875 | N | N | U English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2019-11-14 | 2024-11-14 | English description not available. | N | N | — | ODE-274 + ODE-276 + ODE-370 + ODE-371 + ODE-467
Full coverage date: —
| Source |
| I-817 | 2023-01-19 | 2026-01-19 | English description not available. | N | N | — | — | Source |
| I-817 | 2023-01-19 | 2026-01-19 | English description not available. | N | N | — | ODE-274 + ODE-276 + ODE-370 + ODE-371 + ODE-467
Full coverage date: —
| Source |
| ODE-276 | 2019-11-14 | 2026-11-14 | English description not available. | N | N | — | ODE-274 + ODE-276 + ODE-370 + ODE-371 + ODE-467
Full coverage date: —
| Source |
| ODE* | — | 2026-11-14 | — | — | — | — | Source | |
| I-936 | 2024-03-07 | 2027-03-07 | English description not available. | N | N | — | — | Source |
| I-936 | 2024-03-07 | 2027-03-07 | English description not available. | N | N | — | ODE-274 + ODE-276 + ODE-370 + ODE-371 + ODE-467
Full coverage date: —
| Source |
| ODE-371 | 2021-08-31 | 2028-08-31 | English description not available. | N | N | — | ODE-274 + ODE-276 + ODE-370 + ODE-371 + ODE-467
Full coverage date: —
| Source |
| ODE* | — | 2028-08-31 | — | — | — | — | Source | |
| ODE-370 | 2021-09-14 | 2028-09-14 | English description not available. | N | N | — | ODE-274 + ODE-276 + ODE-370 + ODE-371 + ODE-467
Full coverage date: —
| Source |
| ODE* | — | 2028-09-14 | — | — | — | — | Source | |
| ODE-274 | 2023-01-19 | 2030-01-19 | English description not available. | N | N | — | ODE-274 + ODE-276 + ODE-370 + ODE-371 + ODE-467
Full coverage date: —
| Source |
| ODE* | — | 2030-01-19 | — | — | — | — | Source | |
| ODE-467 | 2024-03-07 | 2031-03-07 | English description not available. | N | N | — | ODE-274 + ODE-276 + ODE-370 + ODE-371 + ODE-467
Full coverage date: —
| Source |
| ODE* | — | 2031-03-07 | — | — | — | — | 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 (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| ANNUAL_DECISION_RECHECK | — | ANCHOR_AND_TAIL | US9447106 c21/22 zanubrutinib. US11884674 BID and US11970500 QD are not crystal-required independent claims; combined-regimen2037 risk retained. CYP3A subset2043 tail. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2034 | DEEP_REVIEW | FINAL | 2034-04-22 | 2026-10-17 20:32:21 |
| N | 2034 | DEEP_REVIEW | FINAL | 2034-04-22 | 2026-10-15 07:23:11 |
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.