OXLUMO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US12723247 independent claims1/2: PH1 human treatment, specified HAO1 dsRNA/salt,3 or6mg/kg subcutaneous. FDA label sections1/2.1/11: all approved age/weight groups and loading/maintenance doses covered. U;TRUE_DS=N;DS-equivalent=Y. Latest of15 listed patents2041-05-29; no later listed patent/exclusivity tail. Correct prior tail-only classification.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10131907 | 2028-08-24 | DS/DP/U U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10131907 | 2028-08-24 | ORANGE_BOOK U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 8828956 | 2028-12-04 | DS/DP/U U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 8828956 | 2028-12-04 | ORANGE_BOOK U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 8106022 | 2029-12-12 | DS/DP/U U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 8106022 | 2029-12-12 | ORANGE_BOOK U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10435692 | 2034-12-26 | U U-2995 | N | N | U English description not available. | — | — | — |
| 10435692 | 2034-12-26 | ORANGE_BOOK U-2995 | N | N | U English description not available. | — | — | — |
| 10465195 | 2034-12-26 | DS/DP/U U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10465195 | 2034-12-26 | ORANGE_BOOK U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10487330 | 2034-12-26 | DS/DP/U U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10487330 | 2034-12-26 | ORANGE_BOOK U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11060093 | 2034-12-26 | DS/DP/U U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11060093 | 2034-12-26 | ORANGE_BOOK U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9828606 | 2034-12-26 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 9828606 | 2034-12-26 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 10612024 | 2035-08-14 | DS/DP/U U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10612024 | 2035-08-14 | ORANGE_BOOK U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10612027 | 2035-08-14 | DS/DP/U U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10612027 | 2035-08-14 | ORANGE_BOOK U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11401517 | 2035-08-14 | DS/DP/U U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11401517 | 2035-08-14 | ORANGE_BOOK U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10478500 | 2035-10-09 | DS/DP/U U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10478500 | 2035-10-09 | ORANGE_BOOK U-2995 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11446380 | 2035-10-09 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 11446380 | 2035-10-09 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 11261447 | 2038-11-20 | DS/DP/U U-2995 | N | N | U English description not available. | — | — | — |
| 11261447 | 2038-11-20 | ORANGE_BOOK U-2995 | N | N | U English description not available. | — | — | — |
| US12723247 | 2041-05-29 | ORANGE_BOOK U-2995 | N | N | U English description not available. | — | — | — |
| US12723247 | 2041-05-29 | DS;DP;U U-2995 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| I-901 | 2022-10-06 | 2025-10-06 | English description not available. | N | N | — | ODE-339 + ODE-415
Full coverage date: —
| Source |
| NCE | 2020-11-23 | 2025-11-23 | English description not available. | Y | Y | 2025-11-23 | ODE-339 + ODE-415
Full coverage date: 2025-11-23
| Source |
| ODE-339 | 2020-11-23 | 2027-11-23 | English description not available. | N | N | — | — | Source |
| ODE-339 | 2020-11-23 | 2027-11-23 | English description not available. | N | N | — | ODE-339 + ODE-415
Full coverage date: —
| Source |
| ODE-415 | 2022-10-06 | 2029-10-06 | English description not available. | N | N | — | — | Source |
| ODE-415 | 2022-10-06 | 2029-10-06 | English description not available. | N | N | — | ODE-339 + ODE-415
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 (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| FULL_YEAR_RECHECK | — | ANCHOR_AND_TAIL | US12723247 independent claims1/2: PH1 human treatment, specified HAO1 dsRNA/salt,3 or6mg/kg subcutaneous. FDA label sections1/2.1/11: all approved age/weight groups and loading/maintenance doses covered. U;TRUE_DS=N;DS-equivalent=Y. Latest of15 listed patents2041-05-29; no later listed patent/exclusivity tail. Correct prior tail-only classification. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2041 | CANDIDATE | FINAL | 2041-05-29 | 2026-10-17 22:44:36 |
| N | 2035 | DEEP_REVIEW | FINAL | 2035-10-09 | 2026-10-15 05:56:56 |
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.