Product profile · United States
MEKTOVI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Rights after the canonical full-scope anchor require DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7777050 | 2027-03-13 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 7777050 | 2027-03-13 | DS/DP — | Y | Y | TRUE_DS Independent claim 1 explicitly claims binimetinib by chemical name or pharmaceutically acceptable salts without formulation or indication limits. | — | — | — |
| 10005761 | 2030-08-27 | U U-3737 | N | Y | DS_EQUIVALENT | — | — | — |
| 10005761 | 2030-08-27 | U U-2331 | N | Y | DS_EQUIVALENT | — | — | — |
| 10005761 | 2030-08-27 | U U-3737 | N | Y | DS_EQUIVALENT Claim 1 broadly treats cancer using encorafenib; both current binimetinib indications require encorafenib. Dependent claim 13 explicitly includes ARRY-438162. Full indication coverage through the mandatory companion, not a binimetinib compound claim. | — | — | — |
| 10005761 | 2030-08-27 | U U-2331 | N | Y | DS_EQUIVALENT Claim 1 broadly treats cancer using encorafenib; both current binimetinib indications require encorafenib. Dependent claim 13 explicitly includes ARRY-438162. Full indication coverage through the mandatory companion, not a binimetinib compound claim. | — | — | — |
| 9850229 | 2030-08-27 | U U-2333 | N | N | PARTIAL_INDICATION_COMBINATION_USE | — | — | — |
| 9850229 | 2030-08-27 | U U-2333 | N | N | PARTIAL_INDICATION_COMBINATION_USE Independent claim 1 requires BRAF-mutant melanoma and encorafenib plus a MEK inhibitor; does not cover approved BRAF-mutant NSCLC. | — | — | — |
| 9314464 | 2031-07-04 | U U-3737 | N | Y | DS_EQUIVALENT | — | — | — |
| 9314464 | 2031-07-04 | U U-2332 | N | Y | DS_EQUIVALENT | — | — | — |
| 9314464 | 2031-07-04 | U U-2332 | N | Y | DS_EQUIVALENT Independent claim 1 treats B-Raf-mediated lung carcinoma and melanoma using an encorafenib-containing genus; both approved binimetinib indications require encorafenib. Formula/species and mandatory-companion label mapping checked. | — | — | — |
| 9314464 | 2031-07-04 | U U-3737 | N | Y | DS_EQUIVALENT Independent claim 1 treats B-Raf-mediated lung carcinoma and melanoma using an encorafenib-containing genus; both approved binimetinib indications require encorafenib. Formula/species and mandatory-companion label mapping checked. | — | — | — |
| 9562016 | 2033-10-18 | DS/DP — | N | N | CRYSTAL_PROCESS_FORMULATION | — | — | — |
| 9562016 | 2033-10-18 | DS/DP — | N | N | CRYSTAL_PROCESS_FORMULATION Crystallized binimetinib product/process and crystalline composition embodiments; no unrestricted drug-substance claim. | — | — | — |
| 9598376 | 2033-10-18 | U U-2330 | N | N | LIMITED_CRYSTAL_USE | — | — | — |
| 9598376 | 2033-10-18 | U U-2330 | N | N | LIMITED_CRYSTAL_USE Crystalline binimetinib use for enumerated cancers including melanoma but not NSCLC; both form and indication restrictions. | — | — | — |
| 9980944 | 2033-10-18 | U U-2334 | N | N | CRYSTAL_RESTRICTED_PARTIAL_USE | — | — | — |
| 9980944 | 2033-10-18 | U U-2334 | N | N | CRYSTAL_RESTRICTED_PARTIAL_USE Independent claim 1 requires crystallized binimetinib and BRAF-mutant melanoma; excludes non-crystalline forms and approved NSCLC. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2018-06-27 | 2023-06-27 | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Y | Y | 2023-06-27 | ODE-194 + I-928
Full coverage date: 2023-06-27
| Source |
| ODE-194 | 2018-06-27 | 2025-06-27 | Encorafenib plus binimetinib for BRAF V600E/V600K unresectable/metastatic melanoma; approved NSCLC remains outside the protected indication. | N | N | — | ODE-194 + I-928
Full coverage date: —
| Source |
| I-928 | 2023-10-11 | 2026-10-11 | ENCORAFENIB IN COMBINATION WITH BINIMETINIB, IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST | N | N | — | ODE-194 + I-928
Full coverage date: —
| Source |
| I-928 | 2023-10-11 | 2026-10-11 | ENCORAFENIB IN COMBINATION WITH BINIMETINIB, IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST | N | N | — | ODE-194 + I-928
Full coverage date: —
| Source |
2026-10-11 · CURRENT_AND_HISTORICAL_RECORDS · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 217678 / 001 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | ALEMBIC PHARMS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
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 | 2027-03-13 | LISTING_CONTEXT | Independent claim 1 explicitly claims binimetinib by chemical name or pharmaceutically acceptable salts without formulation or indication limits. | Source |
| PATENT | 2030-08-27 | LISTING_CONTEXT | Claim 1 broadly treats cancer using encorafenib; both current binimetinib indications require encorafenib. Dependent claim 13 explicitly includes ARRY-438162. Full indication coverage through the mandatory companion, not a binimetinib compound claim. | Source |
| PATENT | 2030-08-27 | LISTING_CONTEXT | Claim 1 broadly treats cancer using encorafenib; both current binimetinib indications require encorafenib. Dependent claim 13 explicitly includes ARRY-438162. Full indication coverage through the mandatory companion, not a binimetinib compound claim. | Source |
| PATENT | 2030-08-27 | LISTING_CONTEXT | Independent claim 1 requires BRAF-mutant melanoma and encorafenib plus a MEK inhibitor; does not cover approved BRAF-mutant NSCLC. | Source |
| PATENT | 2031-07-04 | CANONICAL_ANCHOR | Independent claim 1 treats B-Raf-mediated lung carcinoma and melanoma using an encorafenib-containing genus; both approved binimetinib indications require encorafenib. Formula/species and mandatory-companion label mapping checked. | Source |
| PATENT | 2031-07-04 | CANONICAL_ANCHOR | Independent claim 1 treats B-Raf-mediated lung carcinoma and melanoma using an encorafenib-containing genus; both approved binimetinib indications require encorafenib. Formula/species and mandatory-companion label mapping checked. | Source |
| PATENT | 2033-10-18 | FTO_TAIL | Crystallized binimetinib product/process and crystalline composition embodiments; no unrestricted drug-substance claim. | Source |
| PATENT | 2033-10-18 | FTO_TAIL | Crystalline binimetinib use for enumerated cancers including melanoma but not NSCLC; both form and indication restrictions. | Source |
| PATENT | 2033-10-18 | FTO_TAIL | Independent claim 1 requires crystallized binimetinib and BRAF-mutant melanoma; excludes non-crystalline forms and approved NSCLC. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | ENCORAFENIB IN COMBINATION WITH BINIMETINIB, IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Encorafenib plus binimetinib for BRAF V600E/V600K unresectable/metastatic melanoma; approved NSCLC remains outside the protected indication. | Source |
| REGULATORY_EXCLUSIVITY | 2023-06-27 | SCOPE_CONTEXT | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Source |
| REGULATORY_STATUS | 2031-07-04 | DECISION_BASIS | Rights after the canonical full-scope anchor require DEEP_REVIEW. | 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.