Product profile · United States
OGSIVEO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2030. Anchor type: REGULATORY_EXCLUSIVITY. Patent anchor: 2030-08-18. Exclusivity anchor: 2030-11-27. Anchor date: 2030-11-27. 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 |
|---|---|---|---|---|---|---|---|---|
| 7795447 | 2030-08-18 | DS — | Y | N | TRUE_DS English description not available. | — | — | — |
| 7795447 | 2030-08-18 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 10590087 | 2039-08-09 | DS — | N | N | DP English description not available. | — | — | — |
| 10590087 | 2039-08-09 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 10710966 | 2039-08-09 | DS/U U-3754 | N | N | U English description not available. | — | — | — |
| 10710966 | 2039-08-09 | ORANGE_BOOK U-3754 | N | N | U English description not available. | — | — | — |
| 10941118 | 2039-08-09 | DS/U U-3754 | N | N | DP English description not available. | — | — | — |
| 10941118 | 2039-08-09 | ORANGE_BOOK U-3754 | N | N | DP English description not available. | — | — | — |
| 11820748 | 2039-08-09 | DP — | N | N | DP English description not available. | — | — | — |
| 11820748 | 2039-08-09 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11845732 | 2039-08-09 | DS/U U-3754 | N | N | U English description not available. | — | — | — |
| 11845732 | 2039-08-09 | ORANGE_BOOK U-3754 | N | N | U English description not available. | — | — | — |
| 11884634 | 2039-08-09 | DP — | N | N | DP English description not available. | — | — | — |
| 11884634 | 2039-08-09 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11884635 | 2039-08-09 | DP — | N | N | DP English description not available. | — | — | — |
| 11884635 | 2039-08-09 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11905255 | 2039-08-09 | DP — | N | N | DP English description not available. | — | — | — |
| 11905255 | 2039-08-09 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12116347 | 2039-08-09 | DP — | N | N | DP English description not available. | — | — | — |
| 12116347 | 2039-08-09 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12297177 | 2039-08-09 | DP — | N | N | DP English description not available. | — | — | — |
| 12297177 | 2039-08-09 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11504354 | 2042-07-08 | DP — | N | N | DP English description not available. | — | — | — |
| 11504354 | 2042-07-08 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11612588 | 2042-07-08 | DP/U U-3754 | N | N | U English description not available. | — | — | — |
| 11612588 | 2042-07-08 | ORANGE_BOOK U-3754 | N | N | U English description not available. | — | — | — |
| 12110277 | 2042-07-08 | DP — | N | N | DP English description not available. | — | — | — |
| 12110277 | 2042-07-08 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12234210 | 2042-07-08 | DP — | N | N | PROCESS English description not available. | — | — | — |
| 12234210 | 2042-07-08 | ORANGE_BOOK — | N | N | PROCESS English description not available. | — | — | — |
| 12247012 | 2042-07-08 | DP — | N | N | PROCESS English description not available. | — | — | — |
| 12247012 | 2042-07-08 | ORANGE_BOOK — | N | N | PROCESS English description not available. | — | — | — |
| 12599587 | 2042-07-08 | DP — | N | N | OTHER English description not available. | — | — | — |
| 12599587 | 2042-07-08 | ORANGE_BOOK — | N | N | OTHER English description not available. | — | — | — |
| 11807611 | 2042-09-08 | DP/U U-3754 | N | N | U English description not available. | — | — | — |
| 11807611 | 2042-09-08 | ORANGE_BOOK U-3754 | N | N | U English description not available. | — | — | — |
| 11844780 | 2042-09-08 | DP/U U-3754 | N | N | U English description not available. | — | — | — |
| 11844780 | 2042-09-08 | ORANGE_BOOK U-3754 | N | N | U English description not available. | — | — | — |
| 11872211 | 2043-05-19 | U U-3754 | N | N | U English description not available. | — | — | — |
| 11872211 | 2043-05-19 | ORANGE_BOOK U-3754 | N | N | U English description not available. | — | — | — |
| 11925619 | 2043-05-19 | U U-3754 | N | N | U English description not available. | — | — | — |
| 11925619 | 2043-05-19 | ORANGE_BOOK U-3754 | N | N | U English description not available. | — | — | — |
| 11925620 | 2043-05-19 | U U-3754 | N | N | U English description not available. | — | — | — |
| 11925620 | 2043-05-19 | ORANGE_BOOK U-3754 | N | N | U English description not available. | — | — | — |
| 11938116 | 2043-05-19 | U U-3754 | N | N | U English description not available. | — | — | — |
| 11938116 | 2043-05-19 | ORANGE_BOOK U-3754 | N | N | U English description not available. | — | — | — |
| 11951096 | 2043-05-19 | U U-3754 | N | N | U English description not available. | — | — | — |
| 11951096 | 2043-05-19 | ORANGE_BOOK U-3754 | N | N | U English description not available. | — | — | — |
| 11957662 | 2043-05-19 | U U-3754 | N | N | U English description not available. | — | — | — |
| 11957662 | 2043-05-19 | ORANGE_BOOK U-3754 | N | N | U English description not available. | — | — | — |
| 12011434 | 2043-05-19 | U U-3754 | N | N | U English description not available. | — | — | — |
| 12011434 | 2043-05-19 | ORANGE_BOOK U-3754 | N | N | U English description not available. | — | — | — |
| 12011435 | 2043-05-19 | U U-3754 | N | N | U English description not available. | — | — | — |
| 12011435 | 2043-05-19 | ORANGE_BOOK U-3754 | N | N | U English description not available. | — | — | — |
| 12036207 | 2043-05-19 | U U-3754 | N | N | U English description not available. | — | — | — |
| 12036207 | 2043-05-19 | ORANGE_BOOK U-3754 | N | N | U English description not available. | — | — | — |
| 12138246 | 2043-05-19 | U U-3754 | N | N | U English description not available. | — | — | — |
| 12138246 | 2043-05-19 | ORANGE_BOOK U-3754 | 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 | 2023-11-27 | 2028-11-27 | English description not available. | Y | Y | 2028-11-27 | — | Source |
| NCE | 2023-11-27 | 2028-11-27 | English description not available. | Y | Y | 2028-11-27 | ODE-452
Full coverage date: 2028-11-27
| Source |
| ODE-452 | 2023-11-27 | 2030-11-27 | English description not available. | Y | Y | 2030-11-27 | ODE-452
Full coverage date: 2030-11-27
| Source |
| ODE* | — | 2030-11-27 | — | — | — | — | 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 (32)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2030-08-18 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2039-08-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-08-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-08-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-08-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-08-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-08-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-08-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-08-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-08-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-08-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2042-07-08 | FTO_TAIL | English description not available. | Source |
| PATENT | 2042-07-08 | FTO_TAIL | English description not available. | Source |
| PATENT | 2042-07-08 | FTO_TAIL | English description not available. | Source |
| PATENT | 2042-07-08 | FTO_TAIL | English description not available. | Source |
| PATENT | 2042-07-08 | FTO_TAIL | English description not available. | Source |
| PATENT | 2042-07-08 | FTO_TAIL | English description not available. | Source |
| PATENT | 2042-09-08 | FTO_TAIL | English description not available. | Source |
| PATENT | 2042-09-08 | FTO_TAIL | English description not available. | Source |
| PATENT | 2043-05-19 | FTO_TAIL | English description not available. | Source |
| PATENT | 2043-05-19 | FTO_TAIL | English description not available. | Source |
| PATENT | 2043-05-19 | FTO_TAIL | English description not available. | Source |
| PATENT | 2043-05-19 | FTO_TAIL | English description not available. | Source |
| PATENT | 2043-05-19 | FTO_TAIL | English description not available. | Source |
| PATENT | 2043-05-19 | FTO_TAIL | English description not available. | Source |
| PATENT | 2043-05-19 | FTO_TAIL | English description not available. | Source |
| PATENT | 2043-05-19 | FTO_TAIL | English description not available. | Source |
| PATENT | 2043-05-19 | FTO_TAIL | English description not available. | Source |
| PATENT | 2043-05-19 | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | CANONICAL_ANCHOR | English description not available. | Source |
| REGULATORY_STATUS | 2030-11-27 | 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.