GOMEKLI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US12661330 claim 1 covers NF1 inoperable PN, age>=2, BSA>=1.5m2 and 4mg BID. Whole-4mg-product scope is assessed from the granted claim, FDA-approved strength and published dose table; no new-strength-specific label was obtained. Later LVEF tail remains.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 11066358 | 2041-02-17 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 11066358 | 2041-02-17 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11084780 | 2041-02-17 | DS — | N | N | DP English description not available. | — | — | — |
| 11084780 | 2041-02-17 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11453641 | 2041-02-17 | U U-4130 | N | N | U English description not available. | — | — | — |
| 11453641 | 2041-02-17 | ORANGE_BOOK U-4130 | N | N | U English description not available. | — | — | — |
| 11571402 | 2041-02-17 | DP — | N | N | DP English description not available. | — | — | — |
| 11571402 | 2041-02-17 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11806321 | 2041-02-17 | U U-4130 | N | N | U English description not available. | — | — | — |
| 11806321 | 2041-02-17 | ORANGE_BOOK U-4130 | N | N | U English description not available. | — | — | — |
| 11819487 | 2041-02-17 | U U-4590 | N | N | U English description not available. | — | — | — |
| 11819487 | 2041-02-17 | ORANGE_BOOK U-4590 | N | N | U English description not available. | — | — | — |
| 12037306 | 2041-02-17 | U U-4130 | N | N | U English description not available. | — | — | — |
| 12037306 | 2041-02-17 | ORANGE_BOOK U-4130 | N | N | U English description not available. | — | — | — |
| 12263146 | 2041-02-17 | U U-4130 | N | N | U English description not available. | — | — | — |
| 12263146 | 2041-02-17 | ORANGE_BOOK U-4130 | N | N | U English description not available. | — | — | — |
| 12295925 | 2041-02-17 | U U-4590 | N | N | U English description not available. | — | — | — |
| 12295925 | 2041-02-17 | ORANGE_BOOK U-4590 | N | N | U English description not available. | — | — | — |
| 12357597 | 2041-02-17 | U U-4130 | N | N | U English description not available. | — | — | — |
| 12357597 | 2041-02-17 | ORANGE_BOOK U-4130 | N | N | U English description not available. | — | — | — |
| 12220390 | 2043-03-16 | U U-4130 | N | N | U English description not available. | — | — | — |
| 12220390 | 2043-03-16 | ORANGE_BOOK U-4130 | N | N | U English description not available. | — | — | — |
| 12324791 | 2043-03-16 | U U-4591 | N | N | U English description not available. | — | — | — |
| 12324791 | 2043-03-16 | ORANGE_BOOK U-4591 | N | N | U English description not available. | — | — | — |
| 12661330 | 2044-02-05 | U U-4130 | N | N | U English description not available. | — | — | — |
| 12661330 | 2044-02-05 | ORANGE_BOOK U-4130 | N | N | U English description not available. | — | — | — |
| 12029711 | 2044-03-15 | DP/U U-4130 | N | N | DP English description not available. | — | — | — |
| 12029711 | 2044-03-15 | ORANGE_BOOK U-4130 | N | N | DP English description not available. | — | — | — |
| 12390430 | 2044-10-10 | U U-4130 | N | N | U English description not available. | — | — | — |
| 12390430 | 2044-10-10 | ORANGE_BOOK U-4130 | 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 | 2025-02-11 | 2030-02-11 | English description not available. | Y | Y | 2030-02-11 | — | Source |
| NCE | 2025-02-11 | 2030-02-11 | English description not available. | Y | Y | 2030-02-11 | ODE-488
Full coverage date: 2030-02-11
| Source |
| ODE-488 | 2025-02-11 | 2032-02-11 | English description not available. | Y | Y | 2032-02-11 | ODE-488
Full coverage date: 2032-02-11
| Source |
| ODE* | — | 2032-02-11 | — | — | — | — | 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 | US12661330 claim 1 covers NF1 inoperable PN, age>=2, BSA>=1.5m2 and 4mg BID. Whole-4mg-product scope is assessed from the granted claim, FDA-approved strength and published dose table; no new-strength-specific label was obtained. Later LVEF tail remains. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2044 | DEEP_REVIEW | FINAL | 2044-02-05 | 2026-10-17 06:56:57 |
| N | 2032 | DEEP_REVIEW | FINAL | 2032-02-11 | 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.