Product profile · United States
FINTEPLA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Canonical 2027-12-25; DEEP_REVIEW; latest post-anchor right 2038-12-29; 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 |
|---|---|---|---|---|---|---|---|---|
| 10478441 | 2033-05-03 | U U-2860 | — | — | — | — | — | — |
| 10478442 | 2033-05-03 | U U-2860 | — | — | — | — | — | — |
| 12097206 | 2033-05-03 | U U-4013 | — | — | — | — | — | — |
| 9549909 | 2033-05-03 | U U-2858 | — | — | — | — | — | — |
| 9603814 | 2033-05-03 | U U-2858 | — | — | — | — | — | — |
| 9603815 | 2033-05-03 | U U-2858 | — | — | — | — | — | — |
| 9610260 | 2033-05-03 | U U-2858 | — | — | — | — | — | — |
| 10478441 | 2033-11-03 | — — | — | — | — | — | 2033-11-03 | — |
| 10478441 | 2033-11-03 | ORANGE_BOOK U-2860 | N | N | U English description not available. | — | 2033-11-03 | — |
| 10478442 | 2033-11-03 | — — | — | — | — | — | 2033-11-03 | — |
| 10478442 | 2033-11-03 | ORANGE_BOOK U-2860 | N | N | U English description not available. | — | 2033-11-03 | — |
| 12097206 | 2033-11-03 | — — | — | — | — | — | 2033-11-03 | — |
| 12097206 | 2033-11-03 | ORANGE_BOOK U-4013 | N | N | U English description not available. | — | 2033-11-03 | — |
| 9549909 | 2033-11-03 | — — | — | — | — | — | 2033-11-03 | — |
| 9549909 | 2033-11-03 | ORANGE_BOOK U-2858 | N | N | U English description not available. | — | 2033-11-03 | — |
| 9603814 | 2033-11-03 | — — | — | — | — | — | 2033-11-03 | — |
| 9603814 | 2033-11-03 | ORANGE_BOOK U-2858 | N | N | U English description not available. | — | 2033-11-03 | — |
| 9603815 | 2033-11-03 | — — | — | — | — | — | 2033-11-03 | — |
| 9603815 | 2033-11-03 | ORANGE_BOOK U-2858 | N | N | U English description not available. | — | 2033-11-03 | — |
| 9610260 | 2033-11-03 | — — | — | — | — | — | 2033-11-03 | — |
| 9610260 | 2033-11-03 | ORANGE_BOOK U-2858 | N | N | U English description not available. | — | 2033-11-03 | — |
| 10947183 | 2036-12-20 | DS/DP — | — | — | — | — | — | — |
| 10947183 | 2037-06-20 | — — | — | — | — | — | 2037-06-20 | — |
| 10947183 | 2037-06-20 | ORANGE_BOOK — | N | N | PROCESS English description not available. | — | 2037-06-20 | — |
| 10603290 | 2037-08-02 | U U-2861 | — | — | — | — | — | — |
| 10603290 | 2037-08-02 | U U-3347 | — | — | — | — | — | — |
| 11040018 | 2037-08-02 | U U-3347 | — | — | — | — | — | — |
| 11040018 | 2037-08-02 | U U-2861 | — | — | — | — | — | — |
| 11406606 | 2037-08-02 | U U-3407 | — | — | — | — | — | — |
| 11406606 | 2037-08-02 | U U-3406 | — | — | — | — | — | — |
| 11759440 | 2037-08-02 | U U-3694 | — | — | — | — | — | — |
| 11786487 | 2037-08-02 | U U-3733 | — | — | — | — | — | — |
| 10603290 | 2038-02-02 | — — | — | — | — | — | 2038-02-02 | — |
| 10603290 | 2038-02-02 | ORANGE_BOOK U-2861,U-3347 | N | N | U English description not available. | — | 2038-02-02 | — |
| 11040018 | 2038-02-02 | — — | — | — | — | — | 2038-02-02 | — |
| 11040018 | 2038-02-02 | ORANGE_BOOK U-2861,U-3347 | N | N | U English description not available. | — | 2038-02-02 | — |
| 11406606 | 2038-02-02 | — — | — | — | — | — | 2038-02-02 | — |
| 11406606 | 2038-02-02 | ORANGE_BOOK U-3406,U-3407 | N | N | U English description not available. | — | 2038-02-02 | — |
| 11759440 | 2038-02-02 | — — | — | — | — | — | 2038-02-02 | — |
| 11759440 | 2038-02-02 | ORANGE_BOOK U-3694 | N | N | U English description not available. | — | 2038-02-02 | — |
| 11786487 | 2038-02-02 | — — | — | — | — | — | 2038-02-02 | — |
| 11786487 | 2038-02-02 | ORANGE_BOOK U-3733 | N | N | U English description not available. | — | 2038-02-02 | — |
| 10452815 | 2038-06-29 | U U-2859 | — | — | — | — | — | — |
| 10452815 | 2038-12-29 | — — | — | — | — | — | 2038-12-29 | — |
| 10452815 | 2038-12-29 | ORANGE_BOOK U-2859 | N | N | SYSTEM English description not available. | — | 2038-12-29 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2020-06-25 | 2023-06-25 | English description not available. | N | N | — | Source | |
| PED | 2023-06-25 | 2023-12-25 | English description not available. | N | N | — | Source | |
| I-887 | 2022-03-25 | 2025-03-25 | INDICATION FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS WHO ARE 2 YEARS OF AGE AND OLDER | N | N | — | Source | |
| PED | 2025-03-25 | 2025-09-25 | English description not available. | N | N | — | Source | |
| ODE-312 | — | 2027-06-25 | — | — | — | — | Source | |
| ODE-312 | 2020-06-25 | 2027-06-25 | INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER | N | N | — | Source | |
| PED | — | 2027-12-25 | — | — | — | — | Source | |
| PED | 2027-06-25 | 2027-12-25 | English description not available. | N | N | — | Source | |
| ODE-393 | — | 2029-03-25 | — | — | — | — | Source | |
| ODE-393 | 2022-03-25 | 2029-03-25 | TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS 2 YEARS OF AGE AND OLDER | N | N | — | Source | |
| PED | — | 2029-09-25 | — | — | — | — | Source | |
| PED | 2029-03-25 | 2029-09-25 | 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 (23)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2033-11-03 | FTO_TAIL | English description not available. | Source |
| PATENT | 2033-11-03 | FTO_TAIL | English description not available. | Source |
| PATENT | 2033-11-03 | FTO_TAIL | English description not available. | Source |
| PATENT | 2033-11-03 | FTO_TAIL | English description not available. | Source |
| PATENT | 2033-11-03 | FTO_TAIL | English description not available. | Source |
| PATENT | 2033-11-03 | FTO_TAIL | English description not available. | Source |
| PATENT | 2033-11-03 | FTO_TAIL | English description not available. | Source |
| PATENT | 2037-06-20 | FTO_TAIL | English description not available. | Source |
| PATENT | 2038-02-02 | FTO_TAIL | English description not available. | Source |
| PATENT | 2038-02-02 | FTO_TAIL | English description not available. | Source |
| PATENT | 2038-02-02 | FTO_TAIL | English description not available. | Source |
| PATENT | 2038-02-02 | FTO_TAIL | English description not available. | Source |
| PATENT | 2038-02-02 | FTO_TAIL | English description not available. | Source |
| PATENT | 2038-12-29 | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | INDICATION FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS WHO ARE 2 YEARS OF AGE AND OLDER | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER | Source |
| REGULATORY_EXCLUSIVITY | — | FTO_TAIL | TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS 2 YEARS OF AGE AND OLDER | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | FTO_TAIL | English description not available. | Source |
| REGULATORY_STATUS | 2027-12-25 | CANONICAL_DECISION | Canonical 2027-12-25; DEEP_REVIEW; latest post-anchor right 2038-12-29; 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.