Product profile · United States
TAZVERIK
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DISQUALIFIED. Reference year: 2026. Anchor type: FDA_APPROVAL_WITHDRAWAL. Patent anchor: 2034-01-23. Exclusivity anchor: 2027-01-23. Anchor date: not recorded. Patent tail: yes. 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 |
|---|---|---|---|---|---|---|---|---|
| 10155002 | 2031-09-12 | U U-2736 | N | N | U English description not available. | — | — | — |
| 10155002 | 2031-09-12 | ORANGE_BOOK U-2736 | N | N | U English description not available. | — | — | — |
| 10420775 | 2031-09-12 | U U-2852 | N | Y | U English description not available. | — | — | — |
| 10420775 | 2031-09-12 | U U-2853 | N | Y | U English description not available. | — | — | — |
| 10420775 | 2031-09-12 | U U-2736 | N | Y | U English description not available. | — | — | — |
| 10420775 | 2031-09-12 | ORANGE_BOOK U-2736;U-2852;U-2853 | N | Y | U English description not available. | — | — | — |
| 11052093 | 2031-09-12 | DS/DP/U U-2736 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11052093 | 2031-09-12 | DS/DP/U U-2853 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11052093 | 2031-09-12 | DS/DP/U U-2852 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11052093 | 2031-09-12 | ORANGE_BOOK U-2736;U-2852;U-2853 | Y | N | TRUE_DS English description not available. | — | — | — |
| 12161645 | 2031-09-12 | U U-2853 | N | N | U English description not available. | — | — | — |
| 12161645 | 2031-09-12 | ORANGE_BOOK U-2853 | N | N | U English description not available. | — | — | — |
| 12168015 | 2031-09-12 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 12168015 | 2031-09-12 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 12168016 | 2031-09-12 | U U-2736 | N | Y | U English description not available. | — | — | — |
| 12168016 | 2031-09-12 | U U-2853 | N | Y | U English description not available. | — | — | — |
| 12168016 | 2031-09-12 | ORANGE_BOOK U-2736;U-2853 | N | Y | U English description not available. | — | — | — |
| 8691507 | 2031-09-12 | U U-2852 | N | N | OTHER English description not available. | — | — | — |
| 8691507 | 2031-09-12 | ORANGE_BOOK U-2852 | N | N | OTHER English description not available. | — | — | — |
| 8765732 | 2031-09-12 | U U-2852 | N | N | U English description not available. | — | — | — |
| 8765732 | 2031-09-12 | U U-2853 | N | N | U English description not available. | — | — | — |
| 8765732 | 2031-09-12 | ORANGE_BOOK U-2852;U-2853 | N | N | U English description not available. | — | — | — |
| 8895245 | 2031-09-12 | U U-2852 | N | N | U English description not available. | — | — | — |
| 8895245 | 2031-09-12 | ORANGE_BOOK U-2852 | N | N | U English description not available. | — | — | — |
| 9090562 | 2031-09-12 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 9090562 | 2031-09-12 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 9175331 | 2031-09-12 | U U-2852 | N | N | U English description not available. | — | — | — |
| 9175331 | 2031-09-12 | ORANGE_BOOK U-2852 | N | N | U English description not available. | — | — | — |
| 9333217 | 2031-09-12 | U U-2852 | N | N | U English description not available. | — | — | — |
| 9333217 | 2031-09-12 | ORANGE_BOOK U-2852 | N | N | U English description not available. | — | — | — |
| 9334527 | 2031-09-12 | U U-2852 | N | N | U English description not available. | — | — | — |
| 9334527 | 2031-09-12 | ORANGE_BOOK U-2852 | N | N | U English description not available. | — | — | — |
| 9549931 | 2031-09-12 | U U-2853 | N | Y | U English description not available. | — | — | — |
| 9549931 | 2031-09-12 | U U-2736 | N | Y | U English description not available. | — | — | — |
| 9549931 | 2031-09-12 | U U-2852 | N | Y | U English description not available. | — | — | — |
| 9549931 | 2031-09-12 | ORANGE_BOOK U-2736;U-2852;U-2853 | N | Y | U English description not available. | — | — | — |
| 9855275 | 2031-09-12 | U U-2736 | N | N | U English description not available. | — | — | — |
| 9855275 | 2031-09-12 | ORANGE_BOOK U-2736 | N | N | U English description not available. | — | — | — |
| 9949999 | 2031-09-12 | U U-2851 | N | N | U English description not available. | — | — | — |
| 9949999 | 2031-09-12 | ORANGE_BOOK U-2851 | N | N | U English description not available. | — | — | — |
| 10245269 | 2033-04-11 | U U-2851 | N | N | U English description not available. | — | — | — |
| 10245269 | 2033-04-11 | U U-2854 | N | N | U English description not available. | — | — | — |
| 10245269 | 2033-04-11 | U U-2737 | N | N | U English description not available. | — | — | — |
| 10245269 | 2033-04-11 | ORANGE_BOOK U-2737;U-2851;U-2854 | N | N | U English description not available. | — | — | — |
| 10821113 | 2033-04-11 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 10821113 | 2033-04-11 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11491163 | 2033-04-11 | U U-2853 | N | N | U English description not available. | — | — | — |
| 11491163 | 2033-04-11 | U U-2736 | N | N | U English description not available. | — | — | — |
| 11491163 | 2033-04-11 | U U-2852 | N | N | U English description not available. | — | — | — |
| 11491163 | 2033-04-11 | ORANGE_BOOK U-2736;U-2852;U-2853 | N | N | U English description not available. | — | — | — |
| 9394283 | 2033-04-11 | DS/DP/U U-2852 | N | N | DP English description not available. | — | — | — |
| 9394283 | 2033-04-11 | DS/DP/U U-2853 | N | N | DP English description not available. | — | — | — |
| 9394283 | 2033-04-11 | ORANGE_BOOK U-2852;U-2853 | N | N | DP English description not available. | — | — | — |
| 8410088 | 2034-01-23 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 8410088 | 2034-01-23 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 12162865 | 2034-06-12 | U U-2736 | N | N | U English description not available. | — | — | — |
| 12162865 | 2034-06-12 | ORANGE_BOOK U-2736 | N | N | U English description not available. | — | — | — |
| 9688665 | 2034-08-22 | U U-2736 | N | N | U English description not available. | — | — | — |
| 9688665 | 2034-08-22 | ORANGE_BOOK U-2736 | N | N | U English description not available. | — | — | — |
| 10369155 | 2035-10-16 | U U-2852 | N | N | U English description not available. | — | — | — |
| 10369155 | 2035-10-16 | U U-2736 | N | N | U English description not available. | — | — | — |
| 10369155 | 2035-10-16 | U U-2853 | N | N | U English description not available. | — | — | — |
| 10369155 | 2035-10-16 | ORANGE_BOOK U-2736;U-2852;U-2853 | N | N | U English description not available. | — | — | — |
| 9889138 | 2035-10-16 | U U-2852 | N | N | U English description not available. | — | — | — |
| 9889138 | 2035-10-16 | U U-2853 | N | N | U English description not available. | — | — | — |
| 9889138 | 2035-10-16 | U U-2736 | N | N | U English description not available. | — | — | — |
| 9889138 | 2035-10-16 | ORANGE_BOOK U-2736;U-2852;U-2853 | N | N | U English description not available. | — | — | — |
| 10786511 | 2035-12-19 | DP — | N | N | DP English description not available. | — | — | — |
| 10786511 | 2035-12-19 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12168014 | 2038-05-03 | U U-2853 | N | N | U English description not available. | — | — | — |
| 12168014 | 2038-05-03 | U U-2736 | N | N | U English description not available. | — | — | — |
| 12168014 | 2038-05-03 | U U-2852 | N | N | U English description not available. | — | — | — |
| 12168014 | 2038-05-03 | ORANGE_BOOK U-2736;U-2852;U-2853 | N | N | U English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| I-835 | 2020-06-18 | 2023-06-18 | English description not available. | N | N | — | ODE-299 + ODE-314
Full coverage date: —
| Source |
| I-836 | 2020-06-18 | 2023-06-18 | English description not available. | N | N | — | ODE-299 + ODE-314
Full coverage date: —
| Source |
| NCE | 2020-01-23 | 2025-01-23 | English description not available. | Y | Y | 2025-01-23 | ODE-299 + ODE-314
Full coverage date: 2025-01-23
| Source |
| ODE-299 | 2020-01-23 | 2027-01-23 | English description not available. | N | N | — | — | Source |
| ODE-299 | 2020-01-23 | 2027-01-23 | English description not available. | N | N | — | ODE-299 + ODE-314
Full coverage date: —
| Source |
| ODE-314 | 2020-06-18 | 2027-06-18 | English description not available. | N | N | — | — | Source |
| ODE-314 | 2020-06-18 | 2027-06-18 | English description not available. | N | N | — | ODE-299 + ODE-314
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 (33)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-09-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-04-11 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-04-11 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-04-11 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-04-11 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2034-01-23 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2034-06-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2034-08-22 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-10-16 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-10-16 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-12-19 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2038-05-03 | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | — | TERMINAL_STATUS | 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.