TUKYSA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US8648087 c28 tucatinib. TD2031-01-14 followed by PTE1189days; CRC combination tail2038-04-27.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 9693989 | 2027-05-09 | DP/U U-2788 | N | Y | U | B1C03P7 issued-claim review2026-10-15: U | — | — | — |
| 9693989 | 2027-05-09 | ORANGE_BOOK U-2788 | N | Y | U English description not available. | — | — | — |
| 9457093 | 2032-10-12 | DP/U U-2788 | N | N | DP | B1C03P7 issued-claim review2026-10-15: DP | — | — | — |
| 9457093 | 2032-10-12 | ORANGE_BOOK U-2788 | N | N | DP English description not available. | — | — | — |
| 11504370 | 2033-03-25 | U U-2788 | N | N | U | B1C03P7 issued-claim review2026-10-15: U | — | — | — |
| 11504370 | 2033-03-25 | ORANGE_BOOK U-2788 | N | N | U English description not available. | — | — | — |
| 8648087 | 2034-04-17 | DS/DP — | Y | N | TRUE_DS | B1C03P7 issued-claim review2026-10-15: TRUE_DS | — | — | — |
| 8648087 | 2034-04-17 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 11207324 | 2038-04-27 | U U-3783 | N | N | U | B1C03P7 issued-claim review2026-10-15: U | — | — | — |
| 11207324 | 2038-04-27 | ORANGE_BOOK U-3783 | N | N | U English description not available. | — | — | — |
| 11666572 | 2038-04-27 | U U-3783 | N | N | U | B1C03P7 issued-claim review2026-10-15: U | — | — | — |
| 11666572 | 2038-04-27 | ORANGE_BOOK U-3783 | N | N | U English description not available. | — | — | — |
| 12048698 | 2038-04-27 | U U-3783 | N | N | U | B1C03P7 issued-claim review2026-10-15: U | — | — | — |
| 12048698 | 2038-04-27 | ORANGE_BOOK U-3783 | 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 | 2020-04-17 | 2025-04-17 | English description not available. | Y | Y | 2025-04-17 | NCE
Full coverage date: 2025-04-17
| Source |
| I-906 | 2023-01-19 | 2026-01-19 | English description not available. | N | N | — | — | Source |
| I-906 | 2023-01-19 | 2026-01-19 | English description not available. | N | N | — | NCE
Full coverage date: —
| Source |
| ODE-309 | 2020-04-17 | 2027-04-17 | English description not available. | N | N | — | — | Source |
| ODE-309 | 2020-04-17 | 2027-04-17 | English description not available. | N | N | — | NCE
Full coverage date: —
| Source |
| ODE-422 | 2023-01-19 | 2030-01-19 | English description not available. | N | N | — | — | Source |
| ODE-422 | 2023-01-19 | 2030-01-19 | English description not available. | N | N | — | NCE
Full coverage date: —
| 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 | US8648087 c28 tucatinib. TD2031-01-14 followed by PTE1189days; CRC combination tail2038-04-27. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2034 | DEEP_REVIEW | FINAL | 2034-04-17 | 2026-10-17 20:32:21 |
| N | 2034 | DEEP_REVIEW | FINAL | 2034-04-17 | 2026-10-15 00:56:39 |
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.