Product profile · United States
LENVIMA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Canonical 2026-04-24; DEEP_REVIEW; latest post-anchor right 2038-11-15; Final exact ANDA link not identified; not certified generic absence.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7253286 | 2025-10-24 | DS/DP — | — | — | — | — | — | — |
| 7253286 | 2026-04-24 | — — | — | — | — | — | 2026-04-24 | — |
| 7253286 | 2026-04-24 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | 2026-04-24 | — |
| 7612208 | 2026-09-19 | DS/DP — | — | — | — | — | — | — |
| 7612208 | 2027-03-19 | — — | — | — | — | — | 2027-03-19 | — |
| 7612208 | 2027-03-19 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2027-03-19 | — |
| 9006256 | 2027-07-27 | U U-1695 | — | — | — | — | — | — |
| 9006256 | 2028-01-27 | — — | — | — | — | — | 2028-01-27 | — |
| 9006256 | 2028-01-27 | ORANGE_BOOK U-1695 | N | N | U English description not available. | — | 2028-01-27 | — |
| 12508313 | 2030-10-04 | DP — | — | — | — | — | — | — |
| 12508313 | 2031-04-04 | — — | — | — | — | — | 2031-04-04 | — |
| 12508313 | 2031-04-04 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2031-04-04 | — |
| 10259791 | 2035-08-26 | DS — | — | — | — | — | — | — |
| 10407393 | 2035-08-26 | DS — | — | — | — | — | — | — |
| 11186547 | 2035-08-26 | DS — | — | — | — | — | — | — |
| 11090386 | 2036-02-23 | U U-3519 | — | — | — | — | — | — |
| 10259791 | 2036-02-26 | — — | — | — | — | — | 2036-02-26 | — |
| 10259791 | 2036-02-26 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2036-02-26 | — |
| 10407393 | 2036-02-26 | — — | — | — | — | — | 2036-02-26 | — |
| 10407393 | 2036-02-26 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2036-02-26 | — |
| 11186547 | 2036-02-26 | — — | — | — | — | — | 2036-02-26 | — |
| 11186547 | 2036-02-26 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2036-02-26 | — |
| 12083112 | 2036-03-03 | U U-3996 | — | — | — | — | — | — |
| 12083112 | 2036-03-03 | U U-3997 | — | — | — | — | — | — |
| 11090386 | 2036-08-23 | — — | — | — | — | — | 2036-08-23 | — |
| 11090386 | 2036-08-23 | ORANGE_BOOK U-3519 | N | N | U English description not available. | — | 2036-08-23 | — |
| 12083112 | 2036-09-03 | — — | — | — | — | — | 2036-09-03 | — |
| 12083112 | 2036-09-03 | ORANGE_BOOK U-3996,U-3997 | N | N | U English description not available. | — | 2036-09-03 | — |
| 12226409 | 2038-05-15 | U U-4146 | — | — | — | — | — | — |
| 12226409 | 2038-11-15 | — — | — | — | — | — | 2038-11-15 | — |
| 12226409 | 2038-11-15 | ORANGE_BOOK U-4146 | N | N | U English description not available. | — | 2038-11-15 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| I-734 | 2016-05-13 | 2019-05-13 | EXPANDED INDICATION FOR THE USE OF LENVIMA IN COMBINATION WITH EVEROLIMUS FOR THE TREATMENT OF PATIENTS WITH ADVANCED RCC FOLLOWING ONE PRIOR ANTI-ANGIOGENIC THERAPY | N | N | — | Source | |
| NCE | 2015-02-13 | 2020-02-13 | English description not available. | Y | Y | — | Source | |
| I-787 | 2018-08-15 | 2021-08-15 | FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC) | N | N | — | Source | |
| ODE | 2015-02-13 | 2022-02-13 | ORPHAN DRUG EXCLUSIVITY | N | N | — | Source | |
| ODE-87 | 2015-02-13 | 2022-02-13 | TREATMENT OF PATIENTS WITH LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE, RADIOACTIVE IODINE REFRACTORY DIFFERENTIATED THYROID CANCER | N | N | — | Source | |
| I-807 | 2019-09-17 | 2022-09-17 | TREATMENT OF ADVANCED ENDOMETRIAL CARCINOMA THAT IS NOT MICROSATELLITE INSTABILITY-HIGH OR MISMATCH REPAIR DEFICIENT, WHO HAVE DISEASE PROGRESSION FOLLOWING PRIOR SYSTEMIC THERAPY AND ARE NOT CANDIDATES FOR CURATIVE SURGERY OR RADIATION | N | N | — | Source | |
| M-269 | 2021-07-21 | 2024-07-21 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY 309/KEYNOTE-775 TO SUPPORT PMR 3696-1 AND 3700-1 | N | N | — | Source | |
| I-868 | 2021-08-10 | 2024-08-10 | LENVATINIB IN COMBINATION WITH PEMBROLIZUMAB, IS INDICATED FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH ADVANCED RENAL CELL CARCINOMA (RCC) | N | N | — | Source | |
| M-272 | 2021-12-19 | 2024-12-19 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E7080-G000-211 TO SUPPORT PMR 2865-1 | N | N | — | Source | |
| ODE-196 | — | 2025-08-15 | — | — | — | — | Source | |
| ODE-196 | 2018-08-15 | 2025-08-15 | INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC) | N | N | — | Source | |
| PED | — | 2026-02-15 | — | — | — | — | Source | |
| PED | 2025-08-15 | 2026-02-15 | English description not available. | N | N | — | Source | |
| M-14 | — | 2027-04-03 | — | — | — | — | Source | |
| M-14 | 2024-04-03 | 2027-04-03 | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | N | N | — | Source | |
| PED | — | 2027-10-03 | — | — | — | — | Source | |
| PED | 2027-04-03 | 2027-10-03 | English description not available. | N | N | — | 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 (24)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-04-24 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2027-03-19 | FTO_TAIL | English description not available. | Source |
| PATENT | 2028-01-27 | FTO_TAIL | English description not available. | Source |
| PATENT | 2031-04-04 | FTO_TAIL | English description not available. | Source |
| PATENT | 2036-02-26 | FTO_TAIL | English description not available. | Source |
| PATENT | 2036-02-26 | FTO_TAIL | English description not available. | Source |
| PATENT | 2036-02-26 | FTO_TAIL | English description not available. | Source |
| PATENT | 2036-08-23 | FTO_TAIL | English description not available. | Source |
| PATENT | 2036-09-03 | FTO_TAIL | English description not available. | Source |
| PATENT | 2038-11-15 | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | EXPANDED INDICATION FOR THE USE OF LENVIMA IN COMBINATION WITH EVEROLIMUS FOR THE TREATMENT OF PATIENTS WITH ADVANCED RCC FOLLOWING ONE PRIOR ANTI-ANGIOGENIC THERAPY | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC) | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | TREATMENT OF ADVANCED ENDOMETRIAL CARCINOMA THAT IS NOT MICROSATELLITE INSTABILITY-HIGH OR MISMATCH REPAIR DEFICIENT, WHO HAVE DISEASE PROGRESSION FOLLOWING PRIOR SYSTEMIC THERAPY AND ARE NOT CANDIDATES FOR CURATIVE SURGERY OR RADIATION | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | LENVATINIB IN COMBINATION WITH PEMBROLIZUMAB, IS INDICATED FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH ADVANCED RENAL CELL CARCINOMA (RCC) | Source |
| REGULATORY_EXCLUSIVITY | — | FTO_TAIL | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY 309/KEYNOTE-775 TO SUPPORT PMR 3696-1 AND 3700-1 | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E7080-G000-211 TO SUPPORT PMR 2865-1 | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | ORPHAN DRUG EXCLUSIVITY | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC) | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | TREATMENT OF PATIENTS WITH LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE, RADIOACTIVE IODINE REFRACTORY DIFFERENTIATED THYROID CANCER | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | FTO_TAIL | English description not available. | Source |
| REGULATORY_STATUS | 2026-04-24 | CANONICAL_DECISION | Canonical 2026-04-24; DEEP_REVIEW; latest post-anchor right 2038-11-15; Final exact ANDA link not identified; not certified generic absence. | 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.