XOFLUZA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_MARKETING_DISCONTINUED; US:NDA:210854:001; exact Final ANDA not verified; not proof of generic absence
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 9815835 | 2030-06-14 | DP — | N | Y | U English description not available. | — | — | — |
| 9815835 | 2030-06-14 | ORANGE_BOOK — | N | Y | U English description not available. | — | — | — |
| 8927710 | 2031-05-05 | DP — | N | Y | U English description not available. | — | — | — |
| 8927710 | 2031-05-05 | ORANGE_BOOK — | N | Y | U English description not available. | — | — | — |
| 8987441 | 2032-10-24 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 8987441 | 2032-10-24 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 10392406 | 2036-04-27 | DS — | Y | N | TRUE_DS English description not available. | — | — | — |
| 10392406 | 2036-04-27 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 10633397 | 2036-04-27 | U U-3000 | N | Y | U English description not available. | — | — | — |
| 10633397 | 2036-04-27 | U U-2816 | N | Y | U English description not available. | — | — | — |
| 10633397 | 2036-04-27 | ORANGE_BOOK U-2816,U-3000 | N | Y | U English description not available. | — | — | — |
| 10759814 | 2037-08-09 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 10759814 | 2037-08-09 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11306106 | 2037-08-09 | U U-3000 | N | N | U English description not available. | — | — | — |
| 11306106 | 2037-08-09 | U U-2816 | N | N | U English description not available. | — | — | — |
| 11306106 | 2037-08-09 | ORANGE_BOOK U-2816,U-3000 | N | N | U English description not available. | — | — | — |
| 11261198 | 2038-09-25 | DP — | N | N | OTHER English description not available. | — | — | — |
| 11261198 | 2038-09-25 | ORANGE_BOOK — | N | N | OTHER English description not available. | — | — | — |
| 12064438 | 2039-10-09 | DP — | N | N | DP English description not available. | — | — | — |
| 12064438 | 2039-10-09 | 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 |
|---|---|---|---|---|---|---|---|---|
| I-811 | 2019-10-16 | 2022-10-16 | English description not available. | N | N | — | NCE
Full coverage date: —
| Source |
| NCE | 2018-10-24 | 2023-10-24 | English description not available. | Y | Y | 2023-10-24 | NCE
Full coverage date: 2023-10-24
| Source |
| M-187 | 2024-12-19 | 2027-12-19 | English description not available. | N | N | — | — | Source |
| M-187 | 2024-12-19 | 2027-12-19 | 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 (13)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2030-06-14 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-05-05 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2032-10-24 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2036-04-27 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2036-04-27 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2037-08-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2037-08-09 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2038-09-25 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2039-10-09 | 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 | FDA_MARKETING_DISCONTINUED; US:NDA:210854:001; exact Final ANDA not verified; not proof of generic absence | 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.