KOSELUGO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US7425637 controls 2028-03-13. Existing pediatric ODE ends 2027-04-10, age1-<2 ODE ends 2032-09-10, adult ODE ends 2032-11-19. The scope-union end is 2027-04-10, not the maximum subgroup date. Later age-restricted ODE and formulation tails remain.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8178693 | 2026-03-13 | DS/DP — | Y | N | TRUE_DS | B1C03P8 issued-claim review2026-10-15: TRUE_DS | — | — | — |
| 8178693 | 2026-03-13 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 9156795 | 2026-12-12 | DS/DP — | N | N | DP | B1C03P8 issued-claim review2026-10-15: DP | — | — | — |
| 9156795 | 2026-12-12 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 9562017 | 2026-12-12 | DS/U U-4357 | N | N | U | B1C03P8 issued-claim review2026-10-15: U | — | — | — |
| 9562017 | 2026-12-12 | ORANGE_BOOK U-4357 | N | N | U English description not available. | — | — | — |
| 7425637 | 2028-03-13 | DS — | Y | N | TRUE_DS | B1C03P8 issued-claim review2026-10-15: TRUE_DS | — | — | — |
| 7425637 | 2028-03-13 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 11813246 | 2029-03-26 | DP — | N | N | DP | B1C03P8 issued-claim review2026-10-15: DP | — | — | — |
| 11813246 | 2029-03-26 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12220403 | 2029-03-26 | DP — | N | N | DP | B1C03P8 issued-claim review2026-10-15: DP | — | — | — |
| 12220403 | 2029-03-26 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12318367 | 2029-03-26 | DP — | N | N | DP | B1C03P8 issued-claim review2026-10-15: DP | — | — | — |
| 12318367 | 2029-03-26 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 12364684 | 2029-03-26 | U U-4357 | N | N | U | B1C03P8 issued-claim review2026-10-15: U | — | — | — |
| 12364684 | 2029-03-26 | ORANGE_BOOK U-4357 | 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 | 2020-04-10 | 2025-04-10 | English description not available. | Y | Y | 2025-04-10 | ODE-288 + OOPD_624017_AGE1_LT2 + ODE-545
Full coverage date: 2025-04-10
| Source |
| ODE-288 | 2020-04-10 | 2027-04-10 | English description not available. | N | N | — | — | Source |
| ODE-288 | 2020-04-10 | 2027-04-10 | English description not available. | N | N | — | ODE-288 + OOPD_624017_AGE1_LT2 + ODE-545
Full coverage date: —
| Source |
| NPP | 2025-09-10 | 2028-09-10 | English description not available. | N | N | — | — | Source |
| NPP | 2025-09-10 | 2028-09-10 | English description not available. | N | N | — | ODE-288 + OOPD_624017_AGE1_LT2 + ODE-545
Full coverage date: —
| Source |
| NPP | 2025-11-19 | 2028-11-19 | English description not available. | N | N | — | — | Source |
| NPP | 2025-11-19 | 2028-11-19 | English description not available. | N | N | — | ODE-288 + OOPD_624017_AGE1_LT2 + ODE-545
Full coverage date: —
| Source |
| OOPD_624017_AGE1_LT2 | 2025-09-10 | 2032-09-10 | English description not available. | N | N | — | ODE-288 + OOPD_624017_AGE1_LT2 + ODE-545
Full coverage date: —
| Source |
| ODE-545 | 2025-11-19 | 2032-11-19 | English description not available. | N | N | — | — | Source |
| ODE-545 | 2025-11-19 | 2032-11-19 | English description not available. | N | N | — | ODE-288 + OOPD_624017_AGE1_LT2 + ODE-545
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 |
|---|---|---|---|---|
| FINAL_REVIEW | — | ANCHOR_AND_TAIL | US7425637 controls 2028-03-13. Existing pediatric ODE ends 2027-04-10, age1-<2 ODE ends 2032-09-10, adult ODE ends 2032-11-19. The scope-union end is 2027-04-10, not the maximum subgroup date. Later age-restricted ODE and formulation tails remain. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2028 | DEEP_REVIEW | FINAL | 2028-03-13 | 2026-10-17 06:56:57 |
| N | 2032 | CANDIDATE | FINAL | 2032-11-19 | 2026-10-15 03:06:32 |
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.