OXBRYTA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DISQUALIFIED. Reference year: 2024. Anchor type: FDA_MARKET_WITHDRAWAL. Patent anchor: 2034-01-29. Exclusivity anchor: 2026-11-25. 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 |
|---|---|---|---|---|---|---|---|---|
| 10017491 | 2032-12-28 | DP — | N | Y | U English description not available. | — | — | — |
| 10017491 | 2032-12-28 | ORANGE_BOOK — | N | Y | U English description not available. | — | — | — |
| 10034879 | 2032-12-28 | DS/DP — | N | Y | U English description not available. | — | — | — |
| 10034879 | 2032-12-28 | ORANGE_BOOK — | N | Y | U English description not available. | — | — | — |
| 10806733 | 2032-12-28 | DS — | Y | N | TRUE_DS English description not available. | — | — | — |
| 10806733 | 2032-12-28 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 9018210 | 2033-11-25 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 9018210 | 2033-11-25 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 9248199 | 2034-01-29 | U U-2715 | N | Y | U English description not available. | — | — | — |
| 9248199 | 2034-01-29 | U U-2676 | N | Y | U English description not available. | — | — | — |
| 9248199 | 2034-01-29 | ORANGE_BOOK U-2676;U-2715 | N | Y | U English description not available. | — | — | — |
| 10722502 | 2035-02-06 | DP — | N | N | DP English description not available. | — | — | — |
| 10722502 | 2035-02-06 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11452720 | 2035-02-06 | U U-3459 | N | N | U English description not available. | — | — | — |
| 11452720 | 2035-02-06 | ORANGE_BOOK U-3459 | N | N | U English description not available. | — | — | — |
| 9447071 | 2035-02-06 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 9447071 | 2035-02-06 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11020382 | 2036-12-02 | U U-3133 | N | N | U English description not available. | — | — | — |
| 11020382 | 2036-12-02 | U U-3134 | N | N | U English description not available. | — | — | — |
| 11020382 | 2036-12-02 | ORANGE_BOOK U-3133;U-3134 | N | N | U English description not available. | — | — | — |
| 11944612 | 2036-12-02 | U U-3893 | N | N | DP English description not available. | — | — | — |
| 11944612 | 2036-12-02 | ORANGE_BOOK U-3893 | N | N | DP English description not available. | — | — | — |
| 10493035 | 2037-10-12 | DP — | N | N | DP English description not available. | — | — | — |
| 10493035 | 2037-10-12 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2019-11-25 | 2024-11-25 | English description not available. | Y | Y | 2024-11-25 | ODE-281 + ODE-394
Full coverage date: 2024-11-25
| Source |
| ODE-281 | 2019-11-25 | 2026-11-25 | English description not available. | N | N | — | — | Source |
| ODE-281 | 2019-11-25 | 2026-11-25 | English description not available. | N | N | — | ODE-281 + ODE-394
Full coverage date: —
| Source |
| ODE-394 | 2021-12-17 | 2028-12-17 | English description not available. | N | N | — | — | Source |
| ODE-394 | 2021-12-17 | 2028-12-17 | English description not available. | N | N | — | ODE-281 + ODE-394
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 (15)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2032-12-28 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2032-12-28 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2032-12-28 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-11-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2034-01-29 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-02-06 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-02-06 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-02-06 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2036-12-02 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2036-12-02 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2037-10-12 | 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 | 2024-09-26 | TERMINAL_STATUS | English description not available. | Source |
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.