Product profile · United States
TIBSOVO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: CANDIDATE. Reference year: 2039. Anchor type: PATENT. Patent anchor: 2039-06-07. Exclusivity anchor: 2025-07-20. Anchor date: 2039-06-07. Patent tail: no. Exclusivity tail: no. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10610125 | 2030-06-21 | U U-3385 | N | N | U English description not available. | — | — | — |
| 10610125 | 2030-06-21 | U U-2785 | N | N | U English description not available. | — | — | — |
| 10610125 | 2030-06-21 | U U-2784 | N | N | U English description not available. | — | — | — |
| 10610125 | 2030-06-21 | ORANGE_BOOK U-2784;U-2785;U-3385 | N | N | U English description not available. | — | — | — |
| 10717764 | 2033-01-18 | U U-3215 | N | N | U English description not available. | — | — | — |
| 10717764 | 2033-01-18 | ORANGE_BOOK U-3215 | N | N | U English description not available. | — | — | — |
| 11667673 | 2033-01-18 | U U-3742 | N | N | U English description not available. | — | — | — |
| 11667673 | 2033-01-18 | ORANGE_BOOK U-3742 | N | N | U English description not available. | — | — | — |
| 9850277 | 2033-01-18 | DS/DP/U U-3386 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9850277 | 2033-01-18 | DS/DP/U U-3213 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9850277 | 2033-01-18 | DS/DP/U U-2533 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9850277 | 2033-01-18 | DS/DP/U U-2534 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9850277 | 2033-01-18 | DS/DP/U U-3742 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9850277 | 2033-01-18 | DS/DP/U U-2350 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9850277 | 2033-01-18 | ORANGE_BOOK U-2350;U-2533;U-2534;U-3213;U-3386;U-3742 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9474779 | 2033-08-19 | DS/DP/U U-3742 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9474779 | 2033-08-19 | DS/DP/U U-3213 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9474779 | 2033-08-19 | DS/DP/U U-2534 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9474779 | 2033-08-19 | DS/DP/U U-2533 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9474779 | 2033-08-19 | DS/DP/U U-3386 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9474779 | 2033-08-19 | DS/DP/U U-2350 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9474779 | 2033-08-19 | ORANGE_BOOK U-2350;U-2533;U-2534;U-3213;U-3386;U-3742 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10449184 | 2035-03-13 | DP — | N | N | DP English description not available. | — | — | — |
| 10449184 | 2035-03-13 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 10799490 | 2035-03-13 | DP/U U-3384 | N | N | DP English description not available. | — | — | — |
| 10799490 | 2035-03-13 | DP/U U-2982 | N | N | DP English description not available. | — | — | — |
| 10799490 | 2035-03-13 | DP/U U-2981 | N | N | DP English description not available. | — | — | — |
| 10799490 | 2035-03-13 | ORANGE_BOOK U-2981;U-2982;U-3384 | N | N | DP English description not available. | — | — | — |
| 9968595 | 2035-03-13 | DP/U U-2533 | N | N | DP English description not available. | — | — | — |
| 9968595 | 2035-03-13 | DP/U U-2351 | N | N | DP English description not available. | — | — | — |
| 9968595 | 2035-03-13 | DP/U U-2534 | N | N | DP English description not available. | — | — | — |
| 9968595 | 2035-03-13 | DP/U U-3384 | N | N | DP English description not available. | — | — | — |
| 9968595 | 2035-03-13 | ORANGE_BOOK U-2351;U-2533;U-2534;U-3384 | N | N | DP English description not available. | — | — | — |
| 10653710 | 2036-10-18 | U U-3387 | N | N | U English description not available. | — | — | — |
| 10653710 | 2036-10-18 | ORANGE_BOOK U-3387 | N | N | U English description not available. | — | — | — |
| 10980788 | 2039-06-07 | U U-3214 | N | Y | U English description not available. | — | — | — |
| 10980788 | 2039-06-07 | U U-3113 | N | Y | U English description not available. | — | — | — |
| 10980788 | 2039-06-07 | U U-3112 | N | Y | U English description not available. | — | — | — |
| 10980788 | 2039-06-07 | U U-3743 | N | Y | U English description not available. | — | — | — |
| 10980788 | 2039-06-07 | U U-3383 | N | Y | U English description not available. | — | — | — |
| 10980788 | 2039-06-07 | ORANGE_BOOK U-3112;U-3113;U-3214;U-3383;U-3743 | N | Y | U English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| I-816 | 2019-05-02 | 2022-05-02 | English description not available. | N | N | — | ODE-203 + ODE-242 + ODE-368 + ODE-447
Full coverage date: —
| Source |
| NCE | 2018-07-20 | 2023-07-20 | English description not available. | Y | Y | 2023-07-20 | ODE-203 + ODE-242 + ODE-368 + ODE-447
Full coverage date: 2023-07-20
| Source |
| I-875 | 2021-08-25 | 2024-08-25 | English description not available. | N | N | — | ODE-203 + ODE-242 + ODE-368 + ODE-447
Full coverage date: —
| Source |
| I-893 | 2022-05-25 | 2025-05-25 | English description not available. | N | N | — | ODE-203 + ODE-242 + ODE-368 + ODE-447
Full coverage date: —
| Source |
| ODE-203 | 2018-07-20 | 2025-07-20 | English description not available. | N | N | — | ODE-203 + ODE-242 + ODE-368 + ODE-447
Full coverage date: —
| Source |
| ODE-242 | 2019-05-02 | 2026-05-02 | English description not available. | N | N | — | — | Source |
| ODE-242 | 2019-05-02 | 2026-05-02 | English description not available. | N | N | — | ODE-203 + ODE-242 + ODE-368 + ODE-447
Full coverage date: —
| Source |
| I-924 | 2023-10-24 | 2026-10-24 | English description not available. | N | N | — | — | Source |
| I-924 | 2023-10-24 | 2026-10-24 | English description not available. | N | N | — | ODE-203 + ODE-242 + ODE-368 + ODE-447
Full coverage date: —
| Source |
| ODE-368 | 2021-08-25 | 2028-08-25 | English description not available. | N | N | — | — | Source |
| ODE-368 | 2021-08-25 | 2028-08-25 | English description not available. | N | N | — | ODE-203 + ODE-242 + ODE-368 + ODE-447
Full coverage date: —
| Source |
| ODE-447 | 2023-10-24 | 2030-10-24 | English description not available. | N | N | — | — | Source |
| ODE-447 | 2023-10-24 | 2030-10-24 | English description not available. | N | N | — | ODE-203 + ODE-242 + ODE-368 + ODE-447
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 (20)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2030-06-21 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-01-18 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-01-18 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-01-18 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-08-19 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-03-13 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-03-13 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-03-13 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2036-10-18 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2039-06-07 | CANONICAL_ANCHOR | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | 2039-06-07 | CANONICAL_DECISION | English description not available. | 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.