Product profile · United States
EPIDIOLEX
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2035. Anchor type: PATENT. Patent anchor: 2035-06-17. Exclusivity anchor: 2025-09-28. Anchor date: 2035-06-17. Patent tail: yes. Exclusivity tail: no. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10092525 | 2035-06-17 | U U-2427 | N | N | U English description not available. | — | — | — |
| 10092525 | 2035-06-17 | ORANGE_BOOK U-2427 | N | N | U English description not available. | — | — | — |
| 10111840 | 2035-06-17 | U U-2443 | N | N | U English description not available. | — | — | — |
| 10111840 | 2035-06-17 | U U-2442 | N | N | U English description not available. | — | — | — |
| 10111840 | 2035-06-17 | ORANGE_BOOK U-2442;U-2443 | N | N | U English description not available. | — | — | — |
| 10137095 | 2035-06-17 | U U-2454 | N | N | U English description not available. | — | — | — |
| 10137095 | 2035-06-17 | U U-2455 | N | N | U English description not available. | — | — | — |
| 10137095 | 2035-06-17 | ORANGE_BOOK U-2454;U-2455 | N | N | U English description not available. | — | — | — |
| 10603288 | 2035-06-17 | U U-2781 | N | N | U English description not available. | — | — | — |
| 10603288 | 2035-06-17 | U U-2782 | N | N | U English description not available. | — | — | — |
| 10603288 | 2035-06-17 | U U-2780 | N | N | U English description not available. | — | — | — |
| 10603288 | 2035-06-17 | U U-2783 | N | N | U English description not available. | — | — | — |
| 10603288 | 2035-06-17 | ORANGE_BOOK U-2780;U-2781;U-2782;U-2783 | N | N | U English description not available. | — | — | — |
| 10709671 | 2035-06-17 | U U-2862 | N | N | U English description not available. | — | — | — |
| 10709671 | 2035-06-17 | ORANGE_BOOK U-2862 | N | N | U English description not available. | — | — | — |
| 10709673 | 2035-06-17 | DP — | N | N | DP English description not available. | — | — | — |
| 10709673 | 2035-06-17 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 10709674 | 2035-06-17 | U U-2780 | N | N | U English description not available. | — | — | — |
| 10709674 | 2035-06-17 | U U-2781 | N | N | U English description not available. | — | — | — |
| 10709674 | 2035-06-17 | ORANGE_BOOK U-2780;U-2781 | N | N | U English description not available. | — | — | — |
| 10849860 | 2035-06-17 | U U-2454 | N | N | U English description not available. | — | — | — |
| 10849860 | 2035-06-17 | U U-2427 | N | N | U English description not available. | — | — | — |
| 10849860 | 2035-06-17 | ORANGE_BOOK U-2427;U-2454 | N | N | U English description not available. | — | — | — |
| 10966939 | 2035-06-17 | DP/U U-2781 | N | N | U English description not available. | — | — | — |
| 10966939 | 2035-06-17 | DP/U U-2780 | N | N | U English description not available. | — | — | — |
| 10966939 | 2035-06-17 | ORANGE_BOOK U-2780;U-2781 | N | N | U English description not available. | — | — | — |
| 11154516 | 2035-06-17 | U U-3236 | N | N | U English description not available. | — | — | — |
| 11154516 | 2035-06-17 | U U-3235 | N | N | U English description not available. | — | — | — |
| 11154516 | 2035-06-17 | ORANGE_BOOK U-3235;U-3236 | N | N | U English description not available. | — | — | — |
| 11311498 | 2035-06-17 | U U-3376 | N | N | U English description not available. | — | — | — |
| 11311498 | 2035-06-17 | U U-3375 | N | N | U English description not available. | — | — | — |
| 11311498 | 2035-06-17 | ORANGE_BOOK U-3375;U-3376 | N | N | U English description not available. | — | — | — |
| 11357741 | 2035-06-17 | U U-2862 | N | N | U English description not available. | — | — | — |
| 11357741 | 2035-06-17 | ORANGE_BOOK U-2862 | N | N | U English description not available. | — | — | — |
| 11446258 | 2035-06-17 | U U-2781 | N | Y | U English description not available. | — | — | — |
| 11446258 | 2035-06-17 | U U-2780 | N | Y | U English description not available. | — | — | — |
| 11446258 | 2035-06-17 | U U-3071 | N | Y | U English description not available. | — | — | — |
| 11446258 | 2035-06-17 | ORANGE_BOOK U-2780;U-2781;U-3071 | N | Y | U English description not available. | — | — | — |
| 11633369 | 2035-06-17 | DP/U U-3071 | N | N | U English description not available. | — | — | — |
| 11633369 | 2035-06-17 | DP/U U-2781 | N | N | U English description not available. | — | — | — |
| 11633369 | 2035-06-17 | DP/U U-2780 | N | N | U English description not available. | — | — | — |
| 11633369 | 2035-06-17 | ORANGE_BOOK U-2780;U-2781;U-3071 | N | N | U English description not available. | — | — | — |
| 11701330 | 2035-06-17 | U U-2780 | N | N | U English description not available. | — | — | — |
| 11701330 | 2035-06-17 | U U-2781 | N | N | U English description not available. | — | — | — |
| 11701330 | 2035-06-17 | ORANGE_BOOK U-2780;U-2781 | N | N | U English description not available. | — | — | — |
| 11766411 | 2035-06-17 | U U-2781 | N | N | U English description not available. | — | — | — |
| 11766411 | 2035-06-17 | ORANGE_BOOK U-2781 | N | N | U English description not available. | — | — | — |
| 11963937 | 2035-06-17 | U U-2780 | N | N | U English description not available. | — | — | — |
| 11963937 | 2035-06-17 | U U-2781 | N | N | U English description not available. | — | — | — |
| 11963937 | 2035-06-17 | ORANGE_BOOK U-2780;U-2781 | N | N | U English description not available. | — | — | — |
| 12064399 | 2035-06-17 | U U-3988 | N | N | U English description not available. | — | — | — |
| 12064399 | 2035-06-17 | U U-3989 | N | N | U English description not available. | — | — | — |
| 12064399 | 2035-06-17 | ORANGE_BOOK U-3988;U-3989 | N | N | U English description not available. | — | — | — |
| 9949937 | 2035-06-17 | U U-2421 | N | N | U English description not available. | — | — | — |
| 9949937 | 2035-06-17 | ORANGE_BOOK U-2421 | N | N | U English description not available. | — | — | — |
| 9956183 | 2035-06-17 | U U-2422 | N | N | U English description not available. | — | — | — |
| 9956183 | 2035-06-17 | U U-2423 | N | N | U English description not available. | — | — | — |
| 9956183 | 2035-06-17 | ORANGE_BOOK U-2422;U-2423 | N | N | U English description not available. | — | — | — |
| 9956184 | 2035-06-17 | U U-2424 | N | N | U English description not available. | — | — | — |
| 9956184 | 2035-06-17 | ORANGE_BOOK U-2424 | N | N | U English description not available. | — | — | — |
| 9956185 | 2035-06-17 | U U-2425 | N | N | U English description not available. | — | — | — |
| 9956185 | 2035-06-17 | ORANGE_BOOK U-2425 | N | N | U English description not available. | — | — | — |
| 9956186 | 2035-06-17 | U U-2426 | N | N | U English description not available. | — | — | — |
| 9956186 | 2035-06-17 | ORANGE_BOOK U-2426 | N | N | U English description not available. | — | — | — |
| 10918608 | 2035-10-13 | U U-3071 | N | N | U English description not available. | — | — | — |
| 10918608 | 2035-10-13 | U U-3072 | N | N | U English description not available. | — | — | — |
| 10918608 | 2035-10-13 | U U-3073 | N | N | U English description not available. | — | — | — |
| 10918608 | 2035-10-13 | ORANGE_BOOK U-3071;U-3072;U-3073 | N | N | U English description not available. | — | — | — |
| 11065209 | 2035-10-13 | U U-3071 | N | N | U English description not available. | — | — | — |
| 11065209 | 2035-10-13 | ORANGE_BOOK U-3071 | N | N | U English description not available. | — | — | — |
| 11096905 | 2035-10-13 | DS/DP/U U-2781 | N | N | U English description not available. | — | — | — |
| 11096905 | 2035-10-13 | DS/DP/U U-2780 | N | N | U English description not available. | — | — | — |
| 11096905 | 2035-10-13 | ORANGE_BOOK U-2780;U-2781 | N | N | U English description not available. | — | — | — |
| 11400055 | 2035-10-13 | U U-3071 | N | N | U English description not available. | — | — | — |
| 11400055 | 2035-10-13 | ORANGE_BOOK U-3071 | N | N | U English description not available. | — | — | — |
| 11207292 | 2039-04-26 | DS/U U-3235 | N | N | DP English description not available. | — | — | — |
| 11207292 | 2039-04-26 | DS/U U-3277 | N | N | DP English description not available. | — | — | — |
| 11207292 | 2039-04-26 | DS/U U-3236 | N | N | DP English description not available. | — | — | — |
| 11207292 | 2039-04-26 | ORANGE_BOOK U-3235;U-3236;U-3277 | N | N | DP English description not available. | — | — | — |
| 11865102 | 2039-04-26 | DS/DP/U U-2781 | N | N | DP English description not available. | — | — | — |
| 11865102 | 2039-04-26 | DS/DP/U U-3277 | N | N | DP English description not available. | — | — | — |
| 11865102 | 2039-04-26 | DS/DP/U U-3236 | N | N | DP English description not available. | — | — | — |
| 11865102 | 2039-04-26 | ORANGE_BOOK U-2781;U-3236;U-3277 | N | N | DP English description not available. | — | — | — |
| 11160795 | 2041-03-01 | U U-3233 | N | N | U English description not available. | — | — | — |
| 11160795 | 2041-03-01 | ORANGE_BOOK U-3233 | N | N | U English description not available. | — | — | — |
| 11406623 | 2041-03-01 | U U-3233 | N | N | U English description not available. | — | — | — |
| 11406623 | 2041-03-01 | ORANGE_BOOK U-3233 | N | N | U English description not available. | — | — | — |
| 12102619 | 2041-03-01 | U U-3233 | N | N | U English description not available. | — | — | — |
| 12102619 | 2041-03-01 | ORANGE_BOOK U-3233 | N | N | U English description not available. | — | — | — |
| 12661365 | 2042-09-24 | U U-4573 | N | N | U English description not available. | — | — | — |
| 12661365 | 2042-09-24 | U U-4574 | N | N | U English description not available. | — | — | — |
| 12661365 | 2042-09-24 | U U-4575 | N | N | U English description not available. | — | — | — |
| 12661365 | 2042-09-24 | ORANGE_BOOK U-4573;U-4574;U-4575 | N | N | U English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NPP | 2020-07-31 | 2023-07-31 | English description not available. | N | N | — | ODE-216 + ODE-326 + ODE-332
Full coverage date: —
| Source |
| NCE | 2018-09-28 | 2023-09-28 | English description not available. | Y | Y | 2023-09-28 | ODE-216 + ODE-326 + ODE-332
Full coverage date: 2023-09-28
| Source |
| ODE-216 | 2018-09-28 | 2025-09-28 | English description not available. | N | N | — | ODE-216 + ODE-326 + ODE-332
Full coverage date: —
| Source |
| M-270 | 2023-10-20 | 2026-10-20 | English description not available. | N | N | — | — | Source |
| M-270 | 2023-10-20 | 2026-10-20 | English description not available. | N | N | — | ODE-216 + ODE-326 + ODE-332
Full coverage date: —
| Source |
| ODE-326 | 2020-07-31 | 2027-07-31 | English description not available. | N | N | — | — | Source |
| ODE-326 | 2020-07-31 | 2027-07-31 | English description not available. | N | N | — | ODE-216 + ODE-326 + ODE-332
Full coverage date: —
| Source |
| ODE-332 | 2020-07-31 | 2027-07-31 | English description not available. | N | N | — | — | Source |
| ODE-332 | 2020-07-31 | 2027-07-31 | English description not available. | N | N | — | ODE-216 + ODE-326 + ODE-332
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 (40)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-06-17 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2035-10-13 | FTO_TAIL | English description not available. | Source |
| PATENT | 2035-10-13 | FTO_TAIL | English description not available. | Source |
| PATENT | 2035-10-13 | FTO_TAIL | English description not available. | Source |
| PATENT | 2035-10-13 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-04-26 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-04-26 | FTO_TAIL | English description not available. | Source |
| PATENT | 2041-03-01 | FTO_TAIL | English description not available. | Source |
| PATENT | 2041-03-01 | FTO_TAIL | English description not available. | Source |
| PATENT | 2041-03-01 | FTO_TAIL | English description not available. | Source |
| PATENT | 2042-09-24 | FTO_TAIL | 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 | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | 2035-06-17 | CANONICAL_DECISION | English description not available. | 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.
| Event date | Party | Event | Licensed entry | Evidence | Source |
|---|---|---|---|---|---|
| Not disclosed | Multiple generic applicants | SETTLEMENT | 2030s | REVIEW | — |
| Vague window; company-by-company records pending | |||||