Product profile · United States
QINLOCK
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US8461179 c1 named ripretinib. Formulation/adverse-event/subgroup/interaction tails retained; full downstream mapping incomplete.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8188113 | 2030-07-27 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 8188113 | 2030-07-27 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| RE48731 | 2032-06-07 | U U-3219 | N | N | U English description not available. | — | — | — |
| RE48731 | 2032-06-07 | ORANGE_BOOK U-3219 | N | N | U English description not available. | — | — | — |
| 8461179 | 2034-05-15 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 8461179 | 2034-05-15 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 10966966 | 2040-08-12 | U U-3153 | N | N | U English description not available. | — | — | — |
| 10966966 | 2040-08-12 | ORANGE_BOOK U-3153 | N | N | U English description not available. | — | — | — |
| 11266635 | 2040-08-12 | U U-3330 | N | N | U English description not available. | — | — | — |
| 11266635 | 2040-08-12 | ORANGE_BOOK U-3330 | N | N | U English description not available. | — | — | — |
| 11344536 | 2040-08-12 | U U-3381 | N | N | U English description not available. | — | — | — |
| 11344536 | 2040-08-12 | ORANGE_BOOK U-3381 | N | N | U English description not available. | — | — | — |
| 11426390 | 2040-08-12 | U U-3416 | N | N | U English description not available. | — | — | — |
| 11426390 | 2040-08-12 | ORANGE_BOOK U-3416 | N | N | U English description not available. | — | — | — |
| 11433056 | 2040-08-12 | U U-3423 | N | N | U English description not available. | — | — | — |
| 11433056 | 2040-08-12 | ORANGE_BOOK U-3423 | N | N | U English description not available. | — | — | — |
| 11529336 | 2040-08-12 | U U-3382 | N | N | U English description not available. | — | — | — |
| 11529336 | 2040-08-12 | ORANGE_BOOK U-3382 | N | N | U English description not available. | — | — | — |
| 11534432 | 2040-08-12 | U U-3442 | N | N | U English description not available. | — | — | — |
| 11534432 | 2040-08-12 | ORANGE_BOOK U-3442 | N | N | U English description not available. | — | — | — |
| 11576904 | 2040-08-12 | U U-3537 | N | N | U English description not available. | — | — | — |
| 11576904 | 2040-08-12 | ORANGE_BOOK U-3537 | N | N | U English description not available. | — | — | — |
| 11813251 | 2040-08-12 | U U-3750 | N | N | U English description not available. | — | — | — |
| 11813251 | 2040-08-12 | ORANGE_BOOK U-3750 | N | N | U English description not available. | — | — | — |
| 12023325 | 2040-08-12 | U U-3960 | N | N | U English description not available. | — | — | — |
| 12023325 | 2040-08-12 | ORANGE_BOOK U-3960 | N | N | U English description not available. | — | — | — |
| 12023326 | 2040-08-12 | U U-3959 | N | N | U English description not available. | — | — | — |
| 12023326 | 2040-08-12 | ORANGE_BOOK U-3959 | N | N | U English description not available. | — | — | — |
| 12023327 | 2040-08-12 | U U-3958 | N | N | U English description not available. | — | — | — |
| 12023327 | 2040-08-12 | ORANGE_BOOK U-3958 | N | N | U English description not available. | — | — | — |
| 12059410 | 2040-08-12 | U U-3153 | N | N | U English description not available. | — | — | — |
| 12059410 | 2040-08-12 | ORANGE_BOOK U-3153 | N | N | U English description not available. | — | — | — |
| 12059411 | 2040-08-12 | U U-3971 | N | N | U English description not available. | — | — | — |
| 12059411 | 2040-08-12 | ORANGE_BOOK U-3971 | N | N | U English description not available. | — | — | — |
| 12295944 | 2040-08-12 | U U-4183 | N | N | U English description not available. | — | — | — |
| 12295944 | 2040-08-12 | ORANGE_BOOK U-4183 | N | N | U English description not available. | — | — | — |
| 12318373 | 2040-08-12 | U U-4191 | N | N | U English description not available. | — | — | — |
| 12318373 | 2040-08-12 | ORANGE_BOOK U-4191 | N | N | U English description not available. | — | — | — |
| 11185535 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 11185535 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11395818 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 11395818 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11576903 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 11576903 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11612591 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 11612591 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11793795 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 11793795 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11801237 | 2040-12-30 | DP/U U-3219 | N | N | DP English description not available. | — | — | — |
| 11801237 | 2040-12-30 | ORANGE_BOOK U-3219 | N | N | DP English description not available. | — | — | — |
| 11844788 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 11844788 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11850240 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 11850240 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11850241 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 11850241 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11896585 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 11896585 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11903933 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 11903933 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11911370 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 11911370 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11918564 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 11918564 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11969415 | 2040-12-30 | U U-3219 | N | N | U English description not available. | — | — | — |
| 11969415 | 2040-12-30 | ORANGE_BOOK U-3219 | N | N | U English description not available. | — | — | — |
| 12023328 | 2040-12-30 | U U-3957 | N | N | U English description not available. | — | — | — |
| 12023328 | 2040-12-30 | ORANGE_BOOK U-3957 | N | N | U English description not available. | — | — | — |
| 12064422 | 2040-12-30 | U U-3219 | N | N | U English description not available. | — | — | — |
| 12064422 | 2040-12-30 | ORANGE_BOOK U-3219 | N | N | U English description not available. | — | — | — |
| 12213967 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 12213967 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12213968 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 12213968 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12226406 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 12226406 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12318374 | 2040-12-30 | DP — | N | N | DP English description not available. | — | — | — |
| 12318374 | 2040-12-30 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12708617 | 2040-12-30 | U U-3219 | N | N | U English description not available. | — | — | — |
| 12708617 | 2040-12-30 | ORANGE_BOOK U-3219 | N | N | U English description not available. | — | — | — |
| 11969414 | 2041-02-08 | U U-3897 | N | N | U English description not available. | — | — | — |
| 11969414 | 2041-02-08 | ORANGE_BOOK U-3897 | N | N | U English description not available. | — | — | — |
| 11779572 | 2042-10-06 | U U-3714 | N | N | U English description not available. | — | — | — |
| 11779572 | 2042-10-06 | ORANGE_BOOK U-3714 | 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 | 2020-05-15 | 2025-05-15 | English description not available. | Y | Y | 2025-05-15 | ODE-298
Full coverage date: 2025-05-15
| Source |
| ODE-298 | 2020-05-15 | 2027-05-15 | English description not available. | Y | Y | 2027-05-15 | — | Source |
| ODE-298 | 2020-05-15 | 2027-05-15 | English description not available. | Y | Y | 2027-05-15 | ODE-298
Full coverage date: 2027-05-15
| 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 | US8461179 c1 named ripretinib. Formulation/adverse-event/subgroup/interaction tails retained; full downstream mapping incomplete. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2034 | DEEP_REVIEW | FINAL | 2034-05-15 | 2026-10-17 20:32:21 |
| N | 2034 | DEEP_REVIEW | FINAL | 2034-05-15 | 2026-10-15 05:56:56 |
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.